Long-Term Biological and Behavioural Impact of an Adolescent Sexual Health Intervention in Tanzania: Follow-up Survey of the Community-Based MEMA kwa Vijana Trial

David Ross and colleagues conduct a follow-up survey of the community-based MEMA kwa Vijana (“Good things for young people”) trial in rural Tanzania to assess the long-term behavioral and biological impact of an adolescent sexual health intervention.


Introduction
UNAIDS estimate that, in 2004 1 , over 60% of all new HIV infections occurred in sub-Saharan Africa. About half of these new infections were in youth aged 15-24 years, in whom rates of STI, and unintended pregnancies are also very high. In the absence of a vaccine or cure, behavioural interventions are the main strategy for HIV control, especially amongst youth. Even in the worst affected countries, the prevalence of both HIV and STIs is very low in 15 year olds, but rise steeply after that. If effective interventions that focus on adolescents can be found, they will make a very substantial impact on the HIV epidemic. However, the limited evidence of the effectiveness of behavioural interventions is mainly from developed countries, and is contradictory.
Very few interventions have been rigorously evaluated in the developing world, where the need is greatest. For example, a review carried out in 2004 could only identify 11 school-based HIV prevention programmes in sub-Saharan Africa that had been evaluated using experimental or quasi-experimental designs 2 . Almost all of the programmes had been able to demonstrate an improvement in knowledge about sexual health issues; most showed an improvement in some reported attitudes; but most studies either reported no changes in reported sexual behaviours or changes that were only present in sub-groups. None had evaluated intervention impact on biomedical outcomes, and none had evaluated impact beyond 24 months follow-up, with most (8/11) having their final evaluation within 6 months. Yet evaluation of biological outcomes is critically important because of the limited validity of reported sexual behaviour among young people [3][4][5] , and because of the considerable potential for interventions to differentially bias reported behaviour towards more "desirable" behaviours in the intervention arm. It is also crucially important to know whether interventions will only have transient effects, or affect behaviour and hence HIV incidence for many years. The recent review of the evidence on the effectiveness of interventions to reduce HIV and to meet the HIV-related UNGASS and Millennium MkV1FS_Protocol_Final.doc 8 • Three sexual health knowledge scores and one sexual health attitudes score (each score based on 3 questions, as used in the previous MkV surveys) • Reported sexual behaviours, including: sexual debut, lifetime number of sexual partners, no. different sexual partners in past 12 months, condom use with last non-regular partner, use of other contraceptives at last sexual intercourse. • Reported lifetime number of pregnancies

Study Design
A cross-sectional survey of young people living in the 20 MkV1 trial communities (10 intervention, 10 comparison).
The specific groups who will be invited to participate in the survey are shown in Figure  1.1. In summary, the inclusion criteria will be: • Currently considered to be de jure member of a household within one of the 20 trial communities (allocation to Intervention and comparison arms described in Annex 3). A de jure member of a household is someone who currently sleeps or has previously slept on a regular basis in the household ('Kaya').
• Attended standard 5,6 or 7 in a primary school within a trial community for at least one year between 1999 and 2002 inclusive (the period when the intervention was implemented most intensively and with closest supervision) • Willing to give informed consent to all the study procedures

. Cohort diagram showing those eligible for the survey (2007/2008)-age distribution
• The potential number of years of exposure to the MkV in-school component of intervention, by the end of the calendar year, for those in the 10 intervention communities is represented by the number in each cell. The number of years of exposure will be '0' for the young people who will be invited to participate in the 10 comparison communities (not shown). • The school year groups which include those eligible for the original MkV1 trial cohorts are highlighted in yellow. The other school year groups who had the potential to receive at least one year of the in-school intervention during the period when this was being implemented most intensively (ie. 1999-2002 inclusive) are shown in light blue. The further follow-up survey will be carried out in the second half of 2007 and will include both these school year groups (cross-hatched in row for the end of 2007). • The mean and age ranges are based on an extrapolation from the baseline data (1998) for std 4, 5 and 6 at that time-excluded ages where <1% of school year group had that age.
• The school year groups that have been exposed to the MkV2 intervention in both the intervention AND comparison communities are indicated in pink.

Sample size and Power
The population who are eligible for this survey is limited (ie must have attended the trial primary schools during the selected time period) and so the sample size of 14, 520 was calculated (Box 1.1) based on the number of eligible young people who: (i) Are aged 17-25 years (See NOTE below) (ii) Can be traced during the census and attend the survey (iii) Agree to participate We had previously estimated that 10% of the young people who attended the appropriate years in trial schools would be excluded on age and by removing the age restriction we would expect an increase in the size of the eligible population. However, given the uncertainty around the estimates of the number of eligible young people who can be traced during the census and/or the number who will agree to participate we have made no change to the sample-size.
Despite previous work, the greatest uncertainty is in the HIV prevalence. Using our best estimates, we predict that the study will have adequate power (79%) to detect a 35% reduction in HIV prevalence in females, but only a moderate power (64%) to detect a 40% reduction in males. Similarly, the study will have good power to detect differences of 35% in syphilis and of 25% in HSV2, in each sex. If similar effects are found in the two sexes, it will be possible to combine the results from the two sexes to give greater power. Subgroup analyses for the commoner outcomes such as HSV2, knowledge, attitudes and behaviours will include the impact by age group, number of years of inschool intervention received, and among those who were original MkV cohort members.
We estimate that there will be an average of 720 men and 720 women from each community who had, between 1999 and 2002, completed at least 1 of the final 3 years of primary school in that community. Based on data from the original enrolment survey for the trial, we predict that 90% of these young people will be aged 17-25 years at the end of 2006. We also estimate that 70% of these young adults will still be living in those communities and will be registered during the census, and that 80% will agree to participate in the further follow-up survey. The total sample size will therefore be 14,520 (726 interviewed per community x 20 communities).
The power of the study to detect true reduction in the prevalence of biological outcomes was calculated separately for men and women assuming 365 men and 365 women per community, 10 communities per arm,and k=0.2, where k is the coefficient of variation between communities for that outcome (Table 1.1). The prevalences of all the other endpoints are expected to be greater than 25%, so the study will have greater power for these endpoints. Estimated using prevalence and incidence estimates from other studies in Mwanza Region 2 Difference in prevalence between intervention and comparison communities □ Best estimates of the prevalence of each outcome. Kasamwa (11) Mwagi (23) I1 C1 3.

Questionnaires and Forms
Questionnaires and forms will be based on materials used during MkV1, other surveys conducted in Mwanza and other surveys measuring sexual and reproductive health. Questionnaires and Forms will be designed in Microsoft Word.
Initially, all questionnaires and forms will be drafted in English and will then, where appropriate, be translated into Swahili and Sukuma and back translated into English. All questionnaires and forms will undergo a series of pre-tests and revisions. Final drafts will be used during the pilot study and revised before the survey if necessary.
The following questionnaires will be needed by the census and survey team (in English and Swahili/ Sukuma): • Census questionnaire (programmed into PDA and back-up paper copy) (Annex 7 a-d) • Main questionnaire (Annex 8 a-e) • Main questionnaire-quality control (Annex 9 a-b) A random 10% of participants will answer quality control questionnaires and a list of preselected sticker numbers will be prepared for the survey teamsby the data section.

Census
Following mobilisation, a census will be conducted in each of the survey communities in order to identify young people eligible to participate in the survey. A community (~ward) has a radius of 5-10 km, a population of approximately 18,000 and is made up of approx. 6 villages. There will be two census teams and each census team will work in 10 communities. Each team will comprise of a census team leader (survey deputy team leader) and 8-10 census interviewers and will travel in a project landcruiser. The census team leader (CTL) and census interviewers (CI) will work according to their standard operating procedures (Annex 11 b-d)

Pre-census preparations
With help and supervision from senior MkV1 FS staff, and in collaboration with other census team members, the Census Team Leader (CTL) should make sure that all logistic issues are taken care of and that the census team are ready to go to the field.
The day after the census team arrive in each Ward (Community) they will introduce themselves to the WEO, WEC and other ward officials and let them know that the survey is about to start in the ward. They will provide officials with an updated survey timetable indicating the days that census and survey teams will be in each village and sub-village.
The census team leader (CTL) will then travel to the nearest village (usually near the ward capital) and introduce him/herself to the village executive officer, the village chairperson and the Vitongoji leaders. (The Mobilisation Officer will phone the leaders of this first village a few days before to prepare them for the visit of the census team). He/she will remind them of the survey procedures, inform them that the census will start in their village the next day and provide them with the updated survey timetable. The Vitongoji leaders will be requested to mobilise the residents of their sub-village so that as many of them as possible are present in the sub-village on the day that the census team will visit. They will be encouraged to use the list of HH to help them with this mobilisation.
The CTL will also ask the Vitongoji leaders help to arrange for community helpers to assist the census workers during the census (Kitongoji leader should be one of the helpers). Whenever possible, the CTL should meet with local helpers and explain in detail the purpose and procedures of the census and ensure that the community helpers know their responsibilities during the exercise and amount of payment). These community helpers (CH) will receive 3000 Tsh/ day. Before leaving the kitongoji the CTL will make sure that each "census helper" received his or her incentives/money. While census interviewers (CI) are carrying-out the census in one village/sub-village, the CTL will arrange a pre-census visit to the next village/sub-village as per census schedule (one day before). He/she will do all preparatory activities as explained above.
When the census starts in a village the census team leader (CTL) will go to the guesthouses/ houses that will be used in that village for the survey and ensure that they are ready for the survey team who will arrive 2-4 days later. The CTL will also visit the survey venue a day or two before the survey team arrive in a village in order to ensure that everything is ready for the survey team.

MkV1FS_Protocol_Final.doc 21
The CTL will also complete the Census village information sheet with the help of leaders in the community (Annex 22: Census village information sheet).

Census
The CI will travel to the study site in a Land cruiser (one Land cruiser/team) and will then travel from household to household on foot or by bicycle (project bicycle or hired during the exercise). Each of the 10 CI will work 48 hours/week (8 hours/day for 6 days) and will need to interview approximately 150 households/week each (approx. 20 mins/HH; 25 HH/day/CI) ( Table 3.1). A number of additional days will be needed in each village as some of the households will need to be visited more than once. It should take 3 weeks to complete the census in each community. In order to work more efficiently, the CTL may decide to assign each of the sub-villages in a village to a sub-group of CI.  (1 HH interview in 20 mins,8 hours work) Using the list of household heads prepared by the Kitongoji for the MO, a CI will copy the information on the households onto their CI form for HH (Annex 23:CI form for household head). Using this form, they will go with their community helper (CH) to each of these households. If the CI happens to find some additional household(s) in the Kitongoji, which are not included in the list prepared before, CI will add the household to the list of additional household heads (Annex 18c-d).
In each household (HH) the CI and Community Helper (CH) will briefly introduce themselves to the head of HH or member of the HH and explain briefly the aim of census. The respondent can be the HH head or another member of the HH. Informed consent will be obtained from the respondent prior to questioning (Annex 24ab:Household head consent form).
Each CI will use a hand-help computer (PDA) to directly enter information on household members aged 15-30 years. Eligibility to participate in the survey will be assessed immediately. Eligible young people will be given an appointment 2-4 days later to attend the survey that will be held in a nearby rented building (4-8 venues per study community). If the eligible young person is not present at the time of the census, the other household members will be asked to give the survey invitation to them. The survey invitation (Annex 25a-b: Invitation to attend the main survey) will contain the following information: 1. Location and time of the survey interview If the eligible young person is <18 years of age then the parent or guardian will be given an additional information sheet explaining the survey procedures (Annex 26a-b: Information sheet about main survey for Parent/guardian) and the parent/guardian will be asked to sign a sheet to indicate that they consent for the young person to participate in the survey (Annex 27a-b: Parent/Guardian consent form).
If the household members indicate that the eligible young person will not be able to attend the survey then the CI will record the details of their whereabouts on a moved away form (Annex 28a-b: Moved away form).
Each CI will also have geographical positioning system (GPS) equipment that will allow them to record the exact location of the household and enter this location into the PDA. This information will be used to help locate individual households at a later date eg by tracers or for STI treatment and/or to map the location of the study participants for presentation and further analysis.
If there are any technical problems that prevent the CI using the PDA to record the census data then the CI must use the back-up paper census form (Annex 7a-d).

Generation of lists for survey team
Each evening, the CTL will be responsible for downloading the census data from the PDAs into the laptop. Each evening the CTL will make a copy of the data collected that day onto a blank CD. He/She will be responsible for the storage and safety of the census equipment (i.e. laptop, PDAs/GPS, chargers) and make sure that all equipment are ready for the next day (charged) (Annex 29: PDA and GPS borrowing form). The CTL will, with the help of the CI, complete the census team daily progress report form (Annex 30:CT daily progress report form).
If the paper back-up census questionnaire was used then, in the evening, the CTL with the assistance of the CI will enter the data into an Access Database.
When the census team have completed all the households in one village (~ every 3 days) the CTL will generate and print lists of eligible young people (Lists A1-A3). Lists will be delivered to the survey team (one day before survey).

A1: List of males identified during the MkV1 FS census
List A1 will be ordered by appointment date and then by first name and will contain the following variables: Name of young person (first, surname, other), appointment date, sex, Census ID number, village, sub-village. This list will also have space for the registration interviewer to enter date of survey, registration interviewer ID code and will have space for a sticker.
MkV1FS_Protocol_Final.doc 23 A2: List of females identified during the MkV1 FS census (As A1 above)

A3: List of Household heads
This list will be sorted by village and then by census ID number and will contain names of young person, sex, names of household heads, sub-village and GPS location.
At the end of every village the CTL will complete the census village summary form (Annex 31: Census Village Summary Form) and at the end of the community will complete the census community report form (Annex 32: Census community summary form).

Pre-survey preparations
At least one week before the field trip the team should check that they have all required equipment, documents and other supplies. If there are any problems with the equipment then they must inform the STL. With help and supervision from senior MkV1 FS staff, and in collaboration with other survey team members, the Survey Team Leader (STL) should make sure that all logistic issues are taken care of and that the survey team are ready to go to the field The day before travelling, the team must double-check that they have all equipment/supplies that are needed. They should also attend the ST briefing meeting with the Mobilisation Officer (MO), Field Supervisor (FS) and Fieldwork Manager AND the rest of the ST. During this meeting the MO will give you any important information about the community.
On the day of departure, the team will leave NIMR, Mwanza early in the morning so as to arrive in the survey community (ward capital) in the afternoon/early evening. All travel to the field must start at NIMR, Mwanza.
Each survey team and their equipment will travel from Mwanza to the survey communities in a hired bus (at least 22 seater bus). This bus will be hired only on the specific days that the survey team travel from one community to the next. Each survey team will also have a project land cruiser that will transport them and their equipment from village to village within a community.
When the Survey Team Leader (STL) arrives in the community he/she should meet the CTL and discuss progress with the census and any issues that are important for the survey. The CTL will provide the STL with printed copies of the list of those invited to the survey (Lists A1-A3).
The CTL and STL will make brief visits to the WEO, WEC and other ward officials to provide an update on the progress of the census and remind the officials about the survey timetable and procedures. The STL will then visit leaders in the first village (including Vitongoji leaders) to introduce the survey team and finalise arrangements for the survey.
The CTL and STL will keep in regular contact (by text/ phone) about the survey venue and accommodation for fieldteams.
Each team will arrive in a village approx. 2-4 days after their respective census team and will set up a survey centre in the pre-booked guesthouse or house. The survey centre will have a registration and waiting area (may be outside in a shaded area), 6 rooms for face-to-face interviews, 1 room for the lab technicians, 2 rooms for the VCT counsellors and 1 room for the clinician (10 rooms + registration/waiting area).
The day after arriving in the community (Day 1) one member of each section of the survey team must go to the survey venue with the STL. The STL will allocate an area/ room for each staff member.
We estimate that there will be ~ 14,500 eligible young adults who will turn up at the interview sites. We anticipate that one team can interview 48 participants /day. It will take approximately 15 days to interview the 730 eligible males and females in a community. The team will spend a number of extra days in each community so that they can interview those who were unable to attend the survey at the designated time 'mop-up'. (Table 3.2).

* 4 males and 4 females / hour, 8 hours work
Invited young people will make their own way to the survey centre on the day and time specified on the survey invitation. The census team will aim to invite 64 young people at 08:00 everyday. When the invitees arrive they will be greeted by the attendee coordinator (Annex 11h) who will take them to the registration interviewers (RI). The RI will greet attendees and record the date and time of interview, attendees name, village, sub-village and name of household head in the registration book. They will then be shown to the waiting area where they will be provided with an information sheet (Annex MkV1FS_Protocol_Final.doc 25 33 a-b: Information Sheet for Participants) and a Walkman containing a recording of information on the project (Annex 34: Walkman Lending Form). One of the team members will show attendees how they can play, pause and stop the recording. When an attendee has read the information sheet and/or listened to the Walkman, he/she will be interviewed by the Registration Interviewer.

Registration
There will be two registration interviewers; one for female attendees and one for male attendees and they will follow out the tasks detailed in the registration interviewer standard operating procedures (Annex 11e). Following reading of the information sheet and listening to the Walkman, the RI will interview the attendee and complete section A of the main questionnaire (Annex 8 a-b). The registration interviewer will verify the identification of the attendee by asking them for their survey invitation and/or by finding their name on the census list (A1-A2). They will enter their census ID number into the registration book. The RI will use lists B or C to help them to determine the eligibility of the attendee. If the young person is a member of the MkV1 cohort then the RI will indicate so in the column 'MkV1' in the registration book.
If an attendee is eligible then RI will ask the attendee a series of questions to determine if they are able to give informed consent (Annex 35a-b: Informed Consent Questions). If the attendee is not able to give informed consent then they should return to the waiting area until one of the team members (STL, counsellor or RI) can discuss with them in more detail what the survey will entail. When the team member is confident that the attendee is able to give informed consent, the attendee will return to the RI and will be asked if they consent to participate in the survey. If consent is given then they must sign or thumbprint the informed consent sheet (Annex 36 a-b). The RI will place one sticker (ST1) with a unique survey ID number on the consent form, a second sticker (ST2) with the same number beside their name in the registration book and if their name is on the census list (List A1 or A2) then another sticker (ST3) will be placed beside their name on this list. The fourth, fifth and sixth stickers will be placed on sections A-C of the main questionnaire (ST4-6). Note: (1) Attendees will also be asked if they consent to receiving follow-up treatment for any STIs that is diagnosed after the day of the survey. If they consent to participate in the survey but would not like follow-up treatment then they are still eligible to participate in the survey. (2) If an attendee is unable to give informed consent following discussion with a survey team member then they are deemed not eligible to participate in the survey but may access clinician and VCT services.
All eligible consenting attendees ('participants') will be given a plastic folder containing their main questionnaire and additional stickers (ST7-21). They will then wait in queue for their turn to be interviewed by a survey interviewer.
The registration book and list A1/A2 with stickers attached must be kept securely by the STL until the team returns to Mwanza.

Face-to-face interview
Eligible consenting attendees will then be interviewed using a face-to-face questionnaire (Annex  Questionnaire-Section B) by a survey interviewer (SI) of same sex and similar age. SI will follow the survey interviewer standard operating procedures (Annex 11f). The interviews must take place in a private place, and the completed questionnaires kept safe at all times. After the interview is complete, the main questionnaire should be returned to the participant and they should be directed to the Laboratory Technician.

Laboratory
The laboratory technicians will greet the participant and check that the stickers on the main questionnaire match the remaining stickers in the folder. The lab technicians will then proceed to collect the blood and urine samples for STI testing and screening for Schistosomiasis according to the Laboratory Technician Standard Operating Procedures (Annex 11j). Serum tubes should be labelled with stickers (ST7-9) and urine tubes with stickers (ST10-11). A sticker will be placed in the laboratory registration book and on the Laboratory Submission Form (Annex 45).
The laboratory technicians will test the urine for the presence of RBC using urine dipsticks. The respondent should be given the questionnaire and the ten remaining sticker and directed to the clinician. Female respondents should also be given the container containing the remaining urine sample. This container should be wrapped in tissue paper.

Clinician
The clinician's primary responsibility is to ensure that the survey participants get the correct treatment for any condition that they might have. Thus during the time of the survey, the clinician will only see the survey participants and invited young people who are ineligible for the survey. After the survey has finished, the clinician may see other attendees, but the clinician should avoid treating any other members of the community who did not attend the survey.
The clinician will receive the questionnaires and remaining stickers from the participant. The clinician will first ask about the symptoms that the respondent has at the present time. The treatment protocols are described in section C of the main questionnaire (Annex 8e) , and the clinician's instructions in Annex 11k. All drugs are to be prepacked and clearly labelled before the survey starts. The clinician should not therefore waste time counting tablets or searching for drugs.
All males will receive an external genital examination. Only females who report genital ulcers will be examined. Females should be examined while lying on a mattress on the floor/ bed or chair and male participants should be examined in a standing position. The results should be recorded in section C of the main questionnaire. If a female participant requires treatment for a STI then the clinician must carry out a pregnancy test (on the urine remaining in the 60mL container) before deciding on the most appropriate treatment. All participants who are given treatment for STD related complaints must be asked about their sexual partners and given contact referral slips (Annex 37: Contact Referral Slip). It will usually not be possible for the clinician to see the partners. Partners MkV1FS_Protocol_Final.doc 27 will have to go to the nearest health centre or dispensary for their treatment. STD diagnosis and all treatment provided should be recorded on section C of the main questionnaire (Annex 8e) and in the clinician registration book.
The clinician will explain that Herpes Simplex Virus 2 is a sexually transmitted infection that cannot be cured but can be treated. He/she will explain that many young people are already infected with this disease and will describe the symptoms. He/she will encourage the participant to attend a health facility if they have any genital ulcers in the future.
Finally, the clinician should consult the QC list which indicates individuals (sticker numbers) that need to complete the Quality Control Questionnaire. The Quality Control Questionnaire (Annex 9 a-b) is printed on coloured paper and contains some of the questions from the main questionnaire. The Clinician should attach a sticker to the QC Questionnaire and direct the participant to the other same sex survey interviewer ie SI who did not interview them previously. The participant should complete the QC questionnaire before proceeding to the counsellor (if they would like to visit the counsellor).

Voluntary counselling and testing for HIV (VCT)
Voluntary counselling and testing for HIV will be offered by qualified VCT counsellors (VC) (Annex 11 l-m). Pre-test counselling will be given by the VC and a request for HIV test results form must be signed by the attendee (Annex 38a-b). Blood from those requesting to know their HIV status will be tested immediately at the survey site using two independent blood tests (Bioline and Determine). Post-test counselling will be provided before results are given If the rapid tests result is indeterminate then the participant will be informed that they will need to wait a further test to be carried out on their blood at NIMR, Mwanza (double ELISA) and that a member of the field team will return as soon as possible to give them their result. The VC will complete a VCT discordants form in order to request HIV test results from NIMR laboratory (Annex 39: VCT Discordants Form).
All those who opt for VCT will be informed that a confirmatory test will be carried out on their serum at NIMR, Mwanza and that they may be contacted again if they find that there has been a problem with their test. They will be informed that it is unlikely that there will be a problem with their test.
The VC will complete a VCT results form (Annex 40) and place a sticker on the form. The VCT results form and the VCT registration book will contain a survey sticker but will not contain the name of the participants or any other identifying information.
All those who test positive for HIV will be referred (Annex 41: HIV Treatment Referral Slip) to the nearest health facility offering ART so that their eligibility for ARVs can be assessed. If there is a home based care organisation working in the survey area then they will be put in contact with the organisation so that they can receive supportive counselling and nutritional care.
Unused stickers must be kept in an envelope and returned to the NIMR data section at the same time as the samples and questionnaires are returned.

Checking of questionnaire
Before the participant returns to registration they will meet with the Data Checker who will, according to their SOP (Annex 11g), go through the questionnaire to check that all sections have been completed correctly. If there are any inconsistencies or omissions they will ask the staff member responsible to clarify with the respondent what the answer should be. Figure 3.1 shows the steps that someone turning up at the survey venue will go through and the estimated time each step will take. Taking into account some waiting time between survey steps, the survey will take between 1.5-2.5 hours for those participating in all steps of the survey.

Participant Incentives
When the participants have completed the survey they will be given their incentive by the Data Checker or the Registration Interviewer. Table 3. 3 shows the transport costs and incentives that will be offered to the different categories of attendees.

Tracing
There will be 5 tracers on each survey team and they will be responsible for ensuring that the young people identified during the census attend the survey venue (Annex 11i). On the first day of the survey in a particular village the tracing team will travel in the project landcruiser, by bicycle or by foot to the areas where those invited to the survey on that day are living. They will encourage the invited young people living in that area to attend the survey venue.
On the second day of the survey they will try to mobilise those invited on the second day and will also try to follow-up on those who did not attend on the first day. On the third day they will try to mobilise those invited to attend the survey on the third day and followup on those who were due to attend the previous days. When following-up on young people who did not attend they will record information on the tracing form (Annex 42: Tracing Form).

Team Debrief
At the end of each day the survey team members should attend the team debrief and share their experiences with the rest of the team.
If requested, team members should assist the STL with other tasks including standing in for other members of staff who are ill or on leave.

MkV1FS Protocol 30
At the end of the survey in each village the STL will complete the survey village summary form (Annex 43: Survey village summary form) and submit this form during the next sample/data collection.
In Mwanza (within 2 days of return from the field), all survey team members must complete the following tasks: a. Attend the ST debriefing meeting b. Return all equipment to the project storeroom c. Complete all report (Annex 44: Survey community report form) and retirements required at NIMR office.

Census and Survey reporting and Field staff supervision
During the field visit the Census and Survey Team Leaders will send daily updates (numbers of households visited, YP interviewed, eligible YP interviewed etc) by text message to the mobile phone of the Field Supervisor or Project co-ordinator. They will also submit reports on each village visited.
The day after his/her team returns to Mwanza, the team leader (Census and Survey) should meet with the FS and/or FM to debrief them on ward mobilisation. The CTL and STL should also submit community reports (Annex 32 and Annex 44) to the MkV1 FS team within one week of returning from the ward. The report should contain information on villages/sub-villages visited, days spent at each survey venue, number of HH visited, number of young people interviewed, problems encountered etc.
The NIMR Mwanza-based Project Co-ordinator (PC), Fieldwork Manager (FM) and Field supervisor (FS) will all be involved in the initial supervision of the field teams ie first few communities. They will travel with the field teams and supervise the setting-up of the survey centre, all steps of the survey including specimen and data collection and each step of the survey process. They will also supervise the census fieldworkers, in particular ensuring that the team have no problems using the PDAs and creating the list of survey participants.
When the census and survey teams have completed the first few communities, field supervision will be carried out primarily by the Field supervisor (will spend approx. 75% of his/her time in the field) and will make supervision visits on alternate weeks to both census and survey teams. At each supervision visit, the supervisor must take out sufficient supplies for the 2 teams in the field; this includes the materials for the survey as well as food and personal requirements. All supervisors from Mwanza (FS, FM, PC, technical support) will complete a supervision report form within 2 days of returning to the office (Annex 45).
The FS will aim to visit one of the field teams each week and will spend at least one day with the census team and one day with the survey team during his/her visit. The FS and CTL will observe the CI at work and complete the CI supervision form (Annex 46). They will also conduct blind and non-blind repeat visits to households previously visited by CI and complete the census supervision form (Annex 47). He/she will sit in on some survey interviews and will prepare a summary of the key findings. The FS will also conduct some quality control interviews with the young people and will feedback to the team MkV1FS_Protocol_Final.doc 32 leader if any areas for improvement are identified. The FS will ensure that the team leaders are completing the summary forms as required. During the FS visit to the field, he/she will discuss any problems or concerns relating to the census or survey with local leaders. The PC and FM will occasionally accompany the Field Supervisor on visits to the field sites.

Specimen collection
Blood and urine samples will be processed and packaged for transport by the field laboratory technicians). An additional project Landcruiser will be used for collecting specimens and will travel to meet the teams and collect specimens approximately every week (collect -approx. 183 blood and 183 urine samples). Transportation to NIMR, Mwanza will be in portable freezer and/or heavy-duty coolbox with fresh ice-packs, so that samples are kept at maximum 4°C. Sample submission forms (Annex 48: Lab Submission Form) should be filled in for all samples sent to Mwanza and should be signed by the staff member who delivers the samples and the Lab Assistant who receives the samples in NIMR.

Data collection
Completed questionnaires and other forms (including village census and survey summary forms) will be collected at the same time as the laboratory specimen collection. These forms will be transported to the Data section of MITU where they will be doubleentered. All paper forms and questionnaires sent to NIMR must be accompanied by a Data Submission Form (Annex 49: Data Submission Form) which should be signed by the staff member who delivers the forms and the data manager who receives the forms at NIMR.

Post-survey mopping up
The extent and intensity of mopping-up activities (eg revisiting survey communities, visit to major migration points etc) will depend on the number of young people that participate in the survey.

Post-survey STI treatment
The NIMR, Mwanza lab and data section will, within 5 weeks of receipt of laboratory samples, produce a list of participants who test positive for a treatable STI (active syphilis or NG or CT) and who were not treated using syndromic management. A dedicated team member will return to the communities approximately 2 months after the survey to offer treatment to these individuals (Annex 11q). They will explain that they are making a follow-up to the survey and will only discuss the STI diagnosis and treatment with the participant. They will complete the Treatment after lab results form (Annex 50: Treatment after lab results form) and provide referral slips for contacts if necessary (Annex 51: Contact Referral Slip-follow up STI Rx).
Those who test positive for HSV2 will not be visited, as this is not a curable although it is a treatable infection. During the survey the clinician will counsel all participants on the importance of attending a health facility if they have genital ulcers.

MkV1FS_Protocol_Final.doc 33
In the unlikely event that there is a discrepancy between the VCT test results and the HIV ELISA result then a participant will be revisited. They will be provided with the ELISA test result and will be offered further counselling. Only those who chose to avail of VCT during the survey will be informed if their ELISA test result is positive.

Accommodation
Census and survey teams will sleep in guesthouses or camp (depending on the location) and will be responsible for the safe keeping of the field equipment. Whenever possible, field teams will stay in the same place.

Personnel Identification
Survey team members will be provided with ID cards and must carry them at all times.
All field staff will be provided with project t-shirts so that they can be easily identified. Census interviewers and tracers will also be provided with project baseball caps.

Project Vehicles
The Fieldwork Manager and Team Leaders will be responsible for co-ordinating the use of project vehicles and ensure that they are kept in a roadworthy condition. Drivers will be responsible for refuelling, the basic maintenance and secure parking of the vehicles. Drivers must obey the rules of the road, wear a seatbelt and ensure that all passengers wear a seatbelt (if fitted). Drivers must complete the vehicle logbook for each journey completed (Annex 11o).
Mobilisation Officers are responsible for ensuring that the project motorcycles are kept in a roadworthy condition. They should keep a vehicle log for all journeys and obey the rules of the road. They are required to wear a safety helmet when riding a motorcycle (Annex 11a: Mobilisation Officer SOPs).

Money for fieldwork
All MkV1 FS staff will receive an overnight allowance when they spend a night outside Mwanza carrying out survey activities. The team leader will be responsible for managing the overnight allowances in the field and will keep a list of people who return to Mwanza. The team leader will also manage the money to cover other field expenses. The project payment form will be used where payment is made without invoice or receipt eg payment of community helpers (Annex 52: Payment Voucher).

Communications
Senior MkV1 FS staff will communicate by mobile phone and will be reimbursed for calls/text messages according to the MkV1 FS mobile phone policy. Text messaging will be used wherever possible.

Timeline
The proposed start date is in December 2006 and the project will last 30 months. Four months have been allowed for recruitment and training of the field teams, and for pretesting and pilot testing of the survey procedures. It will take one team approximately 4 MkV1FS_Protocol_Final.doc 34 weeks to carry out the survey and census in each community. Allowance has been made for restocking and a short rest period back in Mwanza between each community and for a repeat visit to each community at the end of the study period to attempt to locate eligible young people who were absent during the first visit. 11.5 months have therefore been allowed for the census and main survey.

Date
Activity Dec'06-Mar'07 Finalising survey protocol, recruitment and training field teams, pilot study May'07-Apr'08 Survey data & specimen collection May'08-Sept'08 Completing data processing & lab analysis Oct'08-May'09 Statistical analysis and writing-up, dissemination of results

Data management
A database will be created by the data section NIMR, Mwanza. Data checks and consistency checks will be built into each file entered by the data entry personnel. No names or other identifiers will be kept on the computers. All data will be double-entered and checked for inconsistencies.
The pilot study data will be examined to assess the success of the questionnaires and forms. The main survey data will be entered within 2 weeks of receipt of data. The first priority will be to enter the main questionnaire. Other questionnaires and forms will be entered in due course with regular feedback being given to both data entry personnel and the field staff on the quality of the data received.

Laboratory analysis
All the main research laboratory tests will be done in the NIMR STI lab (Annex 53: Laboratory Analytical Plan).
HIV will be tested for using two independent antibody/antigen ELISA tests (Murex, Vironostika), with additional confirmation using p24 antigen ELISA and Western Blot (Inno-Lia), as appropriate (Annex 54: HIV testing algorithm).
HSV2 antibodies will be tested for using the kalon HSV2-specific ELISA test. The TPPA test will be used to detect syphilis, with positive also being tested for active syphilis using the RPR test. NG and CT antigen will be tested by PCR (Amplicor), initially in pools of 5 specimens with retesting of each specimen within positive pools.
The laboratory work will be processed within 3 weeks of the specimens being taken. The laboratory results will be taken and entered into the computer by the data entry personnel. Results will be merged and matched based on sticker numbers. Laboratory data from other sites will be collated and merged with the main questionnaire results.

Communication and Dissemination
The MkV1 Further Survey in collaboration with MkV2 have developed a MkV Communication Strategy which outlines the steps that will be taken to disseminate the results of the trial. Stakeholders at all levels from International to local village level will be (iv) vitendo vinavyohusu jamii kuunda mazingira ya kuisaidia mikakati ya afya ya uzazi kwa vijana, ikiwemo wiki moja ya kuanzia ya kuhamasisha jamii, uundaji wa kamati ya kata kusaidia na kusimamia vitendo vya mradi, wiki ya afya ya vijana ya kila mwaka na siku za afya ya vijana za mara mbili kwa mwaka kwenye taasisi za afya za serikali.

01.20
Has the participant signed the consent form? (circle one) q0120 Yes 1

No-refused 2
Not able to give informed consent 3 If refuse or not able to give informed consent then not eligible to continue. Thank and end interview.

01.21
If the laboratory tests in Mwanza show that you have a sexually (circle one) transmitted infection (Syphlis, CT, NG) would you like us to return to treat you?

Do Not prompt the respondent, but after each answer ask him/her to mention as many as possible (TICK ALL THAT APPLY)
Mine employee professional (engineer, accountant, geologist, surveyor etc)     05.07 What are the main kinds of work/activities (shughuli or kazi) this partner does / has done over the last 12 months?

05.14
Why didn't you and your partner use a condom that time? or Why didn't you and your partner use a condom throughout making love that time?
( tick ALL that apply) Not available/ Don't know where to get them q0514a01 q0514b01 q0514c01 Too expensive q0514a02 q0514b02 q0514c02 Do NOT prompt the respondent, Partner objected q0514a03 q0514b03 q0514c03 but after each answer ask, Don't like them q0514a04 q0514b04 q0514c04

"Thank you. Anything else?"
Don't know how to use them q0514a05 q0514b05 q0514c05 Morally wrong / against religion q0514a06 q0514b06 q0514c06 Used other contraceptive q0514a07 q0514b07 q0514c07 Don't have many partners q0514a08 q0514b08 q0514c08 Trust partner q0514a09 q0514b09 q0514c09 Didn't think of it / forgot q0514a10 q0514b10 q0514c10 Did not want to prevent pregnancy q0514a11 q0514b11 q0514c11 Condom broke q0514a12 q0514b12 q0514c12 Don't know q0514a13 q0514b13 q0514c13 Other (specify): partner 1: ___________________________________________ q0514a14 q0514b14 q0514c14 partner 2: ___________________________________________ 06.07 < Males > Sometimes a girl or young woman becomes pregnant when she does not plan to (not a good time to become pregnant).
Have you ever got a girl pregnant when you did not plan to (when it was not a good time)?
MkV1FS Prot A8a_8c Annotated translation of Quest Version SukSwa30may07.doc -14 -06.08 Did you ever use any contraceptive methods to prevent pregnancy while you were making love?
If YES: Which contraceptive methods did you ever use to prevent pregnancy Do not prompt the respondent, but after each answer ask "Thank you. Anything else?" (TICK ALL THAT ARE MENTIONED)

I'm now going to ask you some questions about marriage experience "marital status". Always when I mention the word marriage I am talking about living with somebody as wife/husband. This will include unofficial marriage (in Swahili "Kimada/ Nyumba ndogo") or living with somebody as wife/husband without any initiation ceremony. We know that some young people like you have been married once, others have been married more than once and some have never been married. We are only interested in hearing the truth about young peoples' marriage experiences. This discussion is very confidential between you and me, so I hope that you will be free to tell me about your life marriage experience.
07.01 In total, how many times have you been married OR lived with man / woman as married?
Enter '00' if never married or lived as married and skip to question 07.08 Enter number (two digits) not known = 99 q0701 07.02 How old were you when you first married OR lived with a man / woman as married?

Pubic lice treatment
Lindane 1% lotion or cream. Apply and wash off after 8hrs q1116g1 OR Lindane shampoo. Apply and wash off after 4 minutes q1116g2

VOLUNTARY HIV TESTING
(completed by COUNSELLOR)

All participants should be given the following information about the voluntary HIV testing service.
As the interviewer told you earlier, all the information and the results of the tests on the urine, and blood you have given us will be kept secret. However, if you would like to know whether you are infected with HIV, there is a separate procedure to be followed. If you are interested, I can tell you about this procedure. If, after that, you want to continue, we can do a test now and I can tell you the results of your HIV test. I will also give you further advice. Nobody except you, me and the project's senior staff in Mwanza will know the results Kata (andika jina la kata na namba ya siri)

VOLUNTARY HIV TESTING
(completed by COUNSELLOR)

All participants should be given the following information about the voluntary HIV testing service.
As the interviewer told you earlier, all the information and the results of the tests on the urine, and blood you have given us will be kept secret. However, if you would like to know whether you are infected with HIV, there is a separate procedure to be followed. If you are interested, I can tell you about this procedure. If, after that, you want to continue, we can do a test now and I can tell you the results of your HIV test. I will also give you further advice. Nobody except you, me and the project's senior staff in Mwanza will know the results
29. You must make 1 copy of each list of households prepared by the Vitongoji and leave the original in the MkV1 FS office and give the copy to the CTL.
30. Make 1 copy of each of the contracts for accommodation/ survey venue.
Leave the original in the office and give the copy to the CTL.

You will be issued with a project motorbike for your work. You must keep
proper records on the motorbike, including filling in the logbook after every journey, keeping receipts for fuel and lubricants purchased for the bike, repairs, etc.
32. You must ensure regular maintenance of the motorcycle and provide a verbal report to the Fieldwork Manager after each trip and help him to arrange the repairs.
33. The motorbike should only be used for official duties. If you are found to have been using the motorbike for private use, you will be fined TSh 50,000 and given a written warning on the first occasion, and will be fined TSh 50,000 and dismissed on the second occasion. The fines will be deducted from your monthly salary payments from the project. You must sign a letter agreeing to these terms before being issued with the motorbike.
34. You must observe traffic regulations (e.g. speed, you must wear a safety helmet and other safety gear).
35. You must also report any accidents to the Field Office immediately by:

MKV1 FS: Standard Operation Procedures for Census Interviewer (CI)
1. Make sure that you have the census timetable at least one week before the field trip.
2. One week before leaving for the field make sure that you have the correct and current version of both the SOP and the Protocol, read them carefully and follow the instructions while working/in the field.
3. One week before the field trip check that you have all required equipment (e.g.

PDAs, GPS), documents and other supplies (Census Team Packing List). If
there are any problems with the equipment then inform the CTL.
4. Two days before travelling, collect your imprest from the Project administrator. 6. On the day of departure, you will leave NIMR, Mwanza early in the morning so as to arrive in the survey community (ward capital) in the afternoon/early evening.
All travel to the field must start at NIMR, Mwanza.
7. The day after arriving in the community (Day 1) you must: a. help the CTL with preparations for the census.
b. Pack your bag for Day 2, double-checking that all equipment is working and that you have the necessary forms for your work the following day.
Where possible carry with you extra copies of necessary forms and sheets. 14. If the eligible young person is aged 17 years or younger then you must leave a

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A11b_CI SOP (03Jan08).doc 4 present then ask them to sign the informed consent sheet (read first to them the information on the IC sheet). Signing of the IC sheet must be witnessed by the kitongoji leader or the community helper (must also sign the form). If the parent/guardian is not present or will not immediately sign the IC sheet then inform the HH members that the invited YP who is <18 yrs of age must take the survey invitation AND the IC sheet to the survey. You must submit completed IC sheet for parent/guardian to the CTL at the end of each day.
15. At each household take a waypoint reading using the GPS and record the coordinates in the PDA form. If after 3 attempts, you are unable to get the coordinates then leave the GPS field in the PDA form blank. Report any problems with the GPS to the CTL as soon as possible.
16. You should use the calendar of events to help the respondents recall dates.
17. Report any problems with the PDA, GPS or other equipment to the CTL as soon as possible. All problems must be recorded in the CT equipment notebook.
18. In the unlikely event that it is not possible to use the PDA on the day of the census then the CTL will instruct you to use the  a. Telephone the guesthouse to confirm the accommodation for the CT b. Telephone the leaders of the first village to let them know that the census team will start working in their village on a specific day 7. Two days before travelling, collect your imprests from the Project administrator.
You are responsible for all money and equipment supplied to you.

MEMA kwa Vijana Trial Further Survey (2007-2008
MkV1FS CTL-SOP (04Jan08) 8. The day before travelling you must supervise the packing of all the census team equipment. You are responsible for checking that each piece of electrical equipment is fully charged and/or has spare batteries.
9. The day before travelling, you must arrange a briefing meeting with the Mobilisation Officer (MO), Field Supervisor (FS) and Fieldwork Manager AND the CI. During this meeting the MO will give you any important information about the community.
10. On the day of departure, you will make sure that the CT leaves NIMR Mwanza early in the morning so as to arrive in the survey community (ward capital) in the afternoon/early evening.
11. The day after arriving in the community (Day 1), you will visit the WEO, WEC and other ward officials at the ward office. You will introduce yourself to the ward officials and let them know that the survey is about to start in the ward. You will provide officials with the updated survey timetable indicating the days that the census and survey teams will be in each village and sub-village. During these visits you should ask the WEO if there are any community or political issues that will make the census or survey difficult to carry out. Whenever possible, you should ensure that all community leaders at ward level are aware of the exercise.
If following these discussions you think that it is necessary to change the census timetable then you must immediately contact the Field Supervisor (or Fieldwork Manager/ Project Co-ordinator).
12. On the same day (Day 1), you will travel to the nearest village and introduce yourself to the VEO, VC and the Vitongoji leaders. You will remind them of the census and survey procedures and inform them that the census will start in that village the next day and provide them with an updated census and survey timetable. You must remind them of the need for community helpers, the fact that informed consent will be obtained from the household head (or proxy respondent), the survey eligibility criteria and that the CT will be using small computers (PDA) to collect data. You should request the Vitongoji leaders to mobilise the residents of their sub-village (house-to-house mobilisation) so that

MEMA kwa Vijana Trial Further Survey (2007-2008
MkV1FS CTL-SOP (04Jan08) as many as possible of the residents are present on the day (s) of the census.
You should encourage him/her to use the list of households (HH) to help them with this mobilisation.
13. During this visit (Day 1), you should meet with the community helpers (identified during the mobilisation visit) and explain to them the purpose and procedures of the census. You must ensure that the community helpers (CH) know their responsibilities during the exercise and tell them that they will receive 3000 Tsh/day for their help. Arrange to meet the Kitongoji leader and the other CH at 8:00am the next day (Day 2).
14. On the evening of Day 1 you will hold a short meeting with the CI. Give them on update on your progress during the day and inform them of any changes to the timetable. Assign each CI to specific kitongoji and give them the name of the CH who will be working with them.
15. On the day of the census you must ensure that all CI are equipped to conduct the census (suitably dressed, equipment charged, sufficient copies of all documents etc) and ensure that they have transport to take them to their assigned Kitongoji.
16. Before the census begins you must arrange a meeting with the CI and the CH at the Village/Vitongoji office. During this meeting the CI and CH for each Kitongoji will sit together and discuss the division of households between the CI working in that Kitongoji (if more than 1 CI assigned to that kitongoji 23. Any problems with the PDA, GPS or other equipment must be recorded in the CT equipment notebook. You are responsible for recording problems reported by the CI. If there is a need for replacement equipment then you must inform the FS, FWM or PC as soon as possible.

MEMA kwa Vijana Trial Further Survey (2007-2008
MkV1FS CTL-SOP (04Jan08) accommodation for the survey team. Contact (text message) the survey team leader (STL) 2-3 days before arrival of survey team in the village and provide him/her with an update on the progress of the census and the survey venue /accommodation arrangements.
31. While the CIs are busy conducting the census in village 1, you must go to the next village and carry out the introductions/tasks as in village 1 (see 11 and 12).
The same procedures must be followed in each village in the ward.
32. Under normal circumstances the CT will not spend more than 3 days in each village.
33. When the census has been completed in a village you must generate and print 2 copies of the lists of invitees (Census data SOP). Keep one copy of these lists. f. Complete and submit retirements required at NIMR office.
g. Ensure service of the generator.
h. Make sure that you update antivirus.
i. Make sure that the vehicle logbook is photocopied.

A. Synchronization process (Transfer of Data from PDA to Laptop)
1. Turn on your laptop 2. Connect your synchronization cable to the laptop using the USB-port 3. Insert the synchronization cable into the PDA. You will get a beep sound when the cable is placed in the right way.
4. Press the synchronization button on the cable. You will hear a sound and see a message on your computer telling you that the process is taking place.

5.
When the process has finished remove the PDA.
6. Repeat process 3 and 4 for all the PDA you have.
7. When you are finished with the process of synchronization copy the database onto the CD (see CD burning procedure).
8. This process must be done daily. 13. Click button "Write these files on the disc (DC)'.

B. CD Burning
14. You will see a message saying that the file has been written onto the disc

MKV1 FS: Standard Operation Procedures for Registration Interviewer (RI)
1. Two days before travelling, collect your imprest from the Project administrator.
2. One week before leaving for the field make sure that you have the correct and current version of both the SOP and the Protocol, read them carefully and follow the instructions while working/in the field.
3. When the attendees arrive, greet them and ask them to be seated in the registration waiting area. 5. Wherever possible, one RI will interview male attendees and the other RI will interview female attendees. The RI will share the same registration book.
6. Interview the attendee and complete section A of the main questionnaire: NB All those who attend the survey must be recorded in the registration book AND must be recorded on section A of the main questionnaire. You should not assess eligibility of an attendee before registering them or before completing section A of the main questionnaire.
a. If the name of the attendee is on the list of those invited to the survey LIST A (A1 or A2) then carefully copy the census ID number onto the questionnaire. Only copy the census ID number from the invitation if you cannot find the attendee on List A.
b. Carefully examine any documentation indicating the date of birth of the attendee. If more than one piece of documentation is produced then take the date of birth from the most reliable document eg Birth certificate.

Write 'not read', your staff code and the date beside the question.
f. If attendee did not participate in MkV1 then look on the Std 7 exam results sheets (LIST D) to verify the school attended. If they did not reach Std7 then ask them to name 2 classmates who reached Std 7.
7. If the attendee is eligible then ask the Informed consent check questions to determine if they are able to give informed consent.
a. If the attendee is not able to give informed consent then ask them to return to the registration waiting area until one of the team members (STL, attendee instructor, counsellor or RI) can discuss the survey procedures with them in more detail.
b. When the team member is confident that the attendee is able to give informed consent, you should ask the attendee return to the registration table and ask them if they consent to participate in the survey.
c. Ask the attendee if he/she also consent to receiving follow-up treatment for any STIs that is diagnosed after the day of the survey. Remind them that if they consent to participate in the survey but would not like follow-up treatment then they are still eligible to participate in the survey.
d. If consent is given then ask the attendee to sign or thumbprint the informed consent sheet.

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A11e_RI SOP (04Jan08).doc 3 8. If you are not sure whether an attendee is eligible then discuss with the STL.

ELIGIBLE ATTENDEES (will now be called PARTICIPANTS):
9. If informed consent is given then place one sticker ( 11. If there is a delay until the next SI is available, you must keep the plastic folder so that the participant does not read the Main Questionnaire while waiting. Give the folder to the participant when the interview is to about to begin.

NON-ELIGIBLE ATTENDEES:
12. If an attendee is not eligible, refuses to give informed consent or cannot give informed consent then use stickers for non-participants (begin with XFS…).
Place one sticker (ST1) on the registration book, a second sticker (ST2) on the census list (List A1/A2) and a third sticker (ST3) on section A of the main questionnaire. Thank the attendee and tell them that they are not eligible to participate in the survey. If they were invited to the survey (have invitation or on List A1/A2) then tell them that they may access the clinician and VCT services. If they wish to avail of these services then place a fourth sticker (ST4) on section C of the main questionnaire and direct them to the clinician and/or VCT counsellor.
Give the non-participant a plastic folder (clear bag) containing their main questionnaire (sections A and C only) and additional stickers (ST5-10).
13. If they were not invited or do not wish to avail of these services then tell them that they are free to leave the survey venue.
14. You are responsible, with the help of the attendee co-ordinator, for ensuring that the attendees in the registration waiting area are comfortable. If there are a larger

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A11e_RI SOP (04Jan08).doc 4 number than expected, a fewer number than expected or if attendees are leaving before being interviewed then you must immediately inform the STL.
15. You must make List A1/A2 available to the Tracers so that they can record on list A3 the names of the invited young people who have attended.
16. During the course of the survey, the field data assistant will check the consistency of the questionnaire and will look to see if questions are appropriately skipped. If he/she finds that there are some inconsistency or questions skipped he/she will ask you to re-interview the same client to correct the inconsistency and/or skipped questions. The will be done before the client

MKV1 FS: Standard Operation Procedures for Survey Interviewer (SI)
1. Two days before travelling, collect your imprest from the Project administrator.
2. One week before leaving for the field make sure that you have the correct and current version of both the SOP and the Protocol, read them carefully and follow the instructions while working/in the field.
3. When the participant arrives, greet him/her and ask him/her to be seated on the chair opposite you. Do your best to make sure that the participant is relaxed. 5. Make sure that you ask the participant what language they would like you to use and ensure that you use the language that they request.
6. You must ask the questions slowly using the wording on the questionnaire and in the order that the questions appear.
7. You can repeat questions if you feel it will help the participant's understanding, but you should not prompt answers for the respondent unless explicitly instructed to do so on the questionnaire.
8. The questionnaire must be completed neatly with BLUE PEN. All sections of the questionnaire must be completed. 9. Make sure that you use the Calendar of events to help the participant to remember events in the last 12 months, last month etc.

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A11f_SI SOP (04Jan08).doc 2 10. When asking the questions (especially the questions on sexual behaviour) you must always remain respectful and non-judgemental. You should not show surprise, shock or any negative or positive reactions they may have in response to questions or comments. You must not say anything or display any emotion that will make the participant feel uncomfortable.
11. You should also take care not to influence the participants' answers in any way.
If a participant asks a question during the interview and it is one that can be answered without influencing them (e.g., "How long will this take?"), the interviewer can answer the question. However, if a participant asks a question and you feel an answer might influence them (e.g., "What is a condom?"), you should explain that you cannot answer the question at that time. Instead, you should instruct the participant to ask those questions of the person who gives them soap at the end of the survey.
12. If the participant is unwilling to answer a question then explain again the reason for asking the questions and explain again that all answers will be kept confidential. If the participant still does not want to answer a question then leave blank and continue to the next question.
13. If there are any inconsistencies in the responses provided by the participant (eg reported number of sexual partners) then you should politely remind the participant of the response (s) provided in the previous question/section and try to resolve the inconsistencies.
14. If you make a mistake then cross through the incorrect response and write your staff code and the date beside the correction.
15. During the course of the survey, the field data assistant will check the consistency of the questionnaire and will look to see if questions are appropriately skipped. If he/she finds that there are some inconsistency or questions skipped he/she will ask you to re-interview the same client to correct the inconsistency and/or skipped questions. The will be done before the client

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A11f_SI SOP (04Jan08).doc 3 leaves the survey site. You should reassure the client that they have not done anything wrong but that you made a small mistake and would like to double-check some of the questions.
16. Ten percent of all participants will be also be interviewed using a quality control

MkV1FS: Standard Operating Procedures for Data Checker
1. Two days before travelling, collect your imprest from the project administrator 2. One week before leaving for the field make sure that you have the correct and current version of both the SOP and the Protocol, read them carefully and follow the instructions while working/in the field.
3. On the day of departure, you will leave NIMR, Mwanza early in the morning so as to arrive in the survey community (ward capital) in the afternoon/early evening. All travel to the field must start at NIMR, Mwanza 4. Great the participant when she/he arrives, and ask him to sit on a chair opposite to you.
5. Ask the participant to give you his/her plastic folder with questionnaire. Then apologise to the client that he/she might take a long time waiting while checking the questionnaire.

Remove section A, B and C of the questionnaire and check if is attached with stickers and if the
stickers' numbers match to each section of the questionnaire.
7. Take section A and B of the questionnaire, then start to check the following: (a) All skips are correct (b) All questions that should be completed are completed (c) There is consistency between section A and B eg female in part A should be female in part B, age at first sex or marriage is less than current age (d) In section B also check the consistency between question No. 4 and No.5.
8. If you see any skipped questions or inconsistency, ask the client to wait, and inform him/her that he/she might be interviewed again on some of the questions. Check the staff code of the interviewer and then go and inform him/her that there is some inconsistency in the questionnaire or some questions have not been answered. Then ask the client to go back for the interview. If the particular interviewer is in the middle of an interview with another client then wait till he/she finishes that interview.

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A11g_ Data checker (09Jan08).doc 2 9. After the repeat interview, check again the questionnaire to see if the inconsistency or skip has been corrected. If there is still a problem then you should contact the STL and ask for their assistance. When you are satisfied with the questionnaire, thank the client for being patient give him/her the incentives and tell the client that he/she is free to leave.
10. If the interviewer does not understand the mistakes that have been made, immediately report to the STL to avoid delays to the client.
11. If necessary eg when there are a large number of clients waiting to be interviewed you will work as a backup survey interviewer.
12. You should record in your error record book all the errors found for each questionnaire checked, and then at the end of the day discuss with the TL.
13. At the end of the survey day collect all the questionnaires and arrange them by sections and then submit them to the TL with consent forms from registration and payment vouchers.
14. When requested you must assist the STL with other survey tasks.

MkV1FS: Standard Operating Procedures for Attendee Co-ordinator
1. Two days before travelling, collect your imprest from the Project administrator.
2. One week before leaving for the field make sure that you have the correct and current version of both the SOP and the Protocol, read them carefully and follow the instructions while working/in the field.
3. You should ensure that the reception and registration section is well arranged and organized.

MEMA kwa Vijana Trial Further Survey (2007-2008)
MKV1FS-Attendees-intructor-SOP (04Jan08) 8. When the attendee has completed all relevant stages of the survey, provide all non-eligible invitees (only those who were invited i.e. have invitation and/or name appears on List A) with TSH 2000 and half a bar of soap. Ensure that they sign the payment form. Provide all eligible invitees with TSH 4000 and a full bar of soap. Ensure that they sign the payment form. Non-eligible attendees who were not invited by the census team should not receive any money or soap.
9. Sometimes the attendees need to wait for a long time and you should do your best to make sure that their wait is enjoyable eg by chatting to them, providing them with newspapers/magazines etc. If the STL decides that refreshments should be provided you should ensure that these are distributed fairly.
Refreshments will be provided for the participants and not for staff members.
10. When requested you must assist the Survey Team Leader (STL) with other survey tasks.

MKV1 FS: Standard Operation Procedures for Tracers
1. When the survey is up and running, you will travel to the sub-village allocated to you by the STL. Before leaving you will transfer information from census list A3 (List of Household heads) and registration lists A1/A2 onto your Tracing Form.
You will use this tracing form to help you when you are tracing and will record the outcome of your activities on this form. You will use either the project car or the bicycle for the villages/sub-villages, which are very far from the survey venue, or go on foot for the nearest sub-villages.
2. Two days before travelling, collect your imprest from the Project administrator. 4. On the day of departure, you will leave NIMR, Mwanza early in the morning so as to arrive in the survey community (ward capital) in the afternoon/early evening.
All travel to the field must start at NIMR, Mwanza.

5.
If you discover that the young person will not be able to attend the survey because they are temporarily living elsewhere then you must complete a Moved Away Form for this person.
6. Every evening you will, under the guidance of the Survey Team Leader (STL), make a note of all those who did not attend the survey on that day (by checking the names on List A1/A2 that have no sticker and date of survey beside their name).
7. On subsequent days of the survey you will mobilise those who are due to attend the survey on that day but will also try to find those who did not attend on previous days.
8. When mobilising in the sub-village you should try to speak directly with the invited young person. Explain again the purpose of the survey and request that

MKV1 FS: Standard Operation Procedures for Laboratory Technician (LT)
Procedure for collection of urine specimens and blood by venepuncture Applicable to: All field laboratory personnel

Responsible person: Field Laboratory technicians for MKV1 FS
Aim: To describe the procedure for collecting and aliquoting urine and blood specimens.

Safety:
Treat all samples as potentially infectious.
Appropriate biosafety practices should be adhered to when handling specimens and reagents.
These precautions include but not limited to the following: o Clean and disinfect all spills of specimens, reagent, blood and other potentially contaminated or infectious materials in accordance with local regulations.
NB: If at any stage the gloves get dirty or split, or you are worried that they might have been holed, you should replace them with a new pair. Any discarded pair of gloves must be put into a bucket that is partially filled with disinfectant.

Procedure:
1. Two days before travelling, collect your imprest from the Project administrator.
2. One week before leaving for the field make sure that you have the correct and current version of both the SOP and the Protocol, read them carefully and follow the instructions while working/in the field.
3. When the participant arrives, greet him/her and try to put him/her at ease.

Ask him/her for the plastic folder and check that it contains the main questionnaire
and remaining stickers. Urine specimen collection 7. Ask the participant when s(he) last urinated. If this was less than 2 hours ago then ask him/her to return to the registration area to please wait until 2 hours are up.
8. Put a sticker on the urine container with sellotape.
9. Explain to the participant how to collect urine specimen, and give the labelled container to the participant, asking him/her to go to the latrine to collect urine and bring the urine container back.
NB: Be careful not to send more than one or two participants to the latrine at the same time, to reduce the chance of exchange of urine specimens.
10. Keep the Main Questionnaire and remaining stickers while the participant goes to collect urine specimen.
11. When the participant returns with his or her urine container, one of you should receive the urine container and process the specimen while the other does blood collection (see below).
12. Label two polypropylene tubes with stickers, and check to ensure that the sticker numbers match the one on the urine container. Secure the stickers with sellotape.
13. Using a sterile plastic pasteur pipette, aliquot slightly less than 2mL (approx. 1.8mL) into each of the pre-labelled tubes.
14. Put each aliquot into the appropriate pre-labelled cryobox and place the cryoboxes with the urine specimens in a freezer. Cryoboxes should be labelled as follows: 19. Place the pipette and discarded dipstick into a bucket containing disinfectant.
20. If less than 2 aliquots of urine are collected then please note this on the questionnaire and in the laboratory technician register book.

Blood collection and aliquoting
21. Label with stickers one plain 10mL vacutainer tube and three serum tubes per participant. Ensure the stickers are sealed with sellotape.
22. Explain to the client that you are going to collect blood by venepuncture.
23. Explain to her that there will be a small pain as the needle is inserted into the vein. 39. During the course of the survey, the field data assistant will check the consistency of the questionnaire and will look to see if questions are appropriately skipped. If he/she finds that there are some inconsistency or questions skipped he/she will ask you to re-interview the same client to correct the inconsistency and/or skipped questions. The will be done before the client leaves the survey site. You should reassure the client that they have not done anything wrong but that you made a small mistake and would like to double-check some of the questions.
40. Before leaving the survey site, you must ensure that all of the disposable materials (urine containers, gloves, dipsticks, used hand towels, and the used disinfectant) that you and the counsellor and clinician have used are disposed of properly, either in the pit latrine or burying them.

MKV1 FS: Standard Operating Procedures for Clinician
1. Two days before travelling, collect your imprest from the Project administrator.
2. One week before leaving for the field make sure that you have the correct and current version of both the SOP and the Protocol, read them carefully and follow the instructions while working/in the field.
3. When the young person arrives, greet him/her and ask him/her to be seated on the chair opposite you. Do your best to make sure that they are relaxed.
4. If the young person is a participant ask him/her to give you their plastic folder.
Remove section C of the main questionnaire from the folder and check that there is a sticker attached and that the sticker matches the stickers on Sections A and B and the remaining stickers. If any of the previous sections of the questionnaire have not been completed, the stickers do not match or a sticker is not attached to the questionnaire then ask the participant to return to the registration interviewer.
If everything is in order then you may proceed. If the young person is not participating ('Non-participant') in the survey i.e. has a sticker number starting with XFS… then they will not have section B of the questionnaire.

5.
In order to put the young person at ease, you should then enquire about their general health (i.e., "How are you today?"). After these introductory questions, you should explain what you are going to do next: Ask some questions about the person's reproductive health and treat any illnesses that you find free-of-charge.
You should then check whether the participant is happy to continue.
6. If the young person consents, you should ask each female whether she is pregnant or is currently having her menstrual period, and record the results in 12. Ask the clients to repeat the frequency of how to take drugs to ensure that they have understood and will not overdose or under-dose the drugs when they reach home.

If pregnant clients have schistosomiasis, she should be referred to a near by Health center for treatment after delivery.
15. All young people with a STI will be requested to notify all their recent sexual partners. You should be given a Contact Referral Slip for each of their partners.
The participant will be asked to request their partners to attend a local health facility to receive advice and treatment.
16. If you discover that a young person has a genital ulcer then you should explain pre-test counselling and HIV testing for the source and exposed according to the PEP guidelines. You must ensure that the exposed person travels with 2 vacutainers of blood well labelled ('source' and 'exposed') in a closed envelope with PEP report to PEP supervisors in Mwanza. The STL will assist you if necessary.
23. You should stand in for the Team Leader in the event that the Team Leader is ill or absent for any reason.

MKV1 FS: Standard Operating Procedures for VCT Counsellor (VC)
1. Two days before travelling, collect your imprests from the Project administrator.
2. One week before leaving for field, make sure that you have the correct and current version of both SOP and the Protocol, read them carefully and follow the instructions while working/in the field.
3. On the day of departure, you will leave NIMR, Mwanza early in the morning so as to arrive in the survey community (ward capital) in the afternoon/early evening. All travel to the field must start at NIMR, Mwanza. 5. When the young person arrives, greet him/her and ask him/her to be seated on the chair opposite you. Do your best to make sure that they are relaxed.
6. If the young person is a participant ask him/her to give you their plastic folder.
Remove section C of the main questionnaire from the folder and check that there is a sticker attached and that the sticker matches the stickers on section A and B and the remaining stickers (NOTE: Non-participants will not have section B). If any of the previous parts of the questionnaire have not been completed, the stickers do not match or a sticker is not attached to the questionnaire then ask the participant to return to the registration interviewer. If everything is in order then you may proceed.

Read the "information about the voluntary HIV testing service" that is on the Main
Questionnaire to the young person. is passed from one person to another mainly by sexual intercourse ("making love"). Ways to reduce the risk of becoming infected yourself and/or of infecting someone else include: • Not making love at all (sexual abstinence). This is the safest way.
• Only making love with one partner whom you trust.
• Particularly avoiding casual (one-off) sexual partners • Always using a condom when making love.
14. Ask the young person why they want to know their HIV test result. This should lead naturally into asking them what they think the potential advantages and disadvantages of knowing their HIV status are.
You should ensure that this discussion includes: Thank them and tell them that you will now burn their result in front of them, so nobody will ever be able to know their result.

Potential Advantages Potential Disadvantages
Burn the HIV VCT Results Form front of the participant.
Thank them, ask them if they have any further questions and end the consultation.
Record in the Counsellor Record Book that the young person did not want to know their result.
25. If the participants say they want to know the result: Tell them that, before giving them their result, you want to go over the same information that you gave them before the test. Remind them of the information in (9) and (10)  Ask whether the participant has any further questions, and answer them to the best of your ability, and as truthfully as possible.
Tell them their result.

If the result is negative:
o Remind them that the body does not react to the HIV virus immediately, and the test can still be negative for up to about 6 months after HIV infection. In other words, it is possible for someone who has been infected recently to test negative.
o Discuss a personal risk-reduction plan with them to ensure that they stay negative.
o Ask them whether they have any questions, and answer them to the best of your ability, and as truthfully as possible.

Potential Elements of a Personal Risk-Reduction Plan
• Not making love at all (sexual abstinence). This is the safest way.
• Only making love with one partner whom you trust.
• Always using a condom when making love. o Discuss ways in which they can reduce the risk of infecting other people.

Ways to Reduce the Risk of Infecting Other People
• Not making love at all (sexual abstinence). This is the safest way.
• Always using a condom when making love.
o Before closing the session, ensure that their immediate plans, intentions and actions have been reviewed.

If the result is indeterminate
o If Eligible and blood sample has been collected by lab: Explain to the client that the result is not clear and that you need to wait for a confirmatory test that will be carried out on the blood sample that has already been collected.
o If not eligible OR blood sample has not been collected by lab: Take a blood sample using a vacutainer (according to the Blood collection and aliquoting SOP). Deliver the labelled vacutainer immediately to the

MkV1FS: Standard Operating Procedures for the SD-Bioline HIV 1 / 2 and Determine Rapid Tests
Applicable to: All personnel of the field team

Responsible person: Counsellors
Aim: To describe the procedure for performing the SD-Bioline and Determine HIV rapid tests.

Safety:
Treat all samples as potentially infectious.
Appropriate biosafety practices should be adhered to when handling specimens and reagents.
These precautions include but not limited to the following: -Wear gloves -Do not pipette by mouth -Do not eat, drink, smoke, apply cosmetics or handle lenses at the areas of work.
-Clean and disinfect all spills of specimens, reagent, blood and other potentially contaminated or infectious materials in accordance with local regulations.
NB: If at any stage the gloves get dirty or split, or you are worried that they might have been holed, you should replace them with a new pair. Any discarded pair of gloves must be put into a bucket that is partially filled with disinfectant.

Specimen collection
Whole blood collected by finger prick should be done aseptically.

MEMA kwa Vijana Trial Further Survey (2007-2008)
MKV1FS Prot A11n_STL SOP (08Jan08).doc 9. On the day of departure, you will make sure that the ST leaves NIMR Mwanza early in the morning so as to arrive in the survey community (ward capital) in the afternoon/early evening. All travel to the field must start at NIMR, Mwanza.
10. The day you arrive you will meet with the census TL. The CTL will give you a brief update on the progress of the census and give you lists A1, A2 and A3 for the first village. The CTL will also give you the parent/guardian informed consent sheets for the invitees <18 years of age and any completed moved away forms.
11. Along with the CTL, you are responsible for negotiation with the village and subvillage leaders to ensure their active co-operation, and paying them as necessary for assistance.
12. On the day after arriving in the community (Day 1), your team will proceed to the survey venue in the first village. You will introduce yourself and your team to the venue owners and look at all the rooms in the venue. Then you will allocate rooms/areas to the different team members and ask the team to begin setting up their equipment.
13. While the team are setting up their equipment you should introduce yourself to the VEO, VC and the Vitongoji leaders in that Village and remind them of the length of time that the survey will be taking place in their village. You should request the Vitongoji leaders to mobilise the residents of their sub-village (houseto-house mobilisation) so that as many as possible of the invited young people attend the survey location.
14. On the day of the survey you must ensure that all survey team members are equipped to conduct their duties (suitably dressed, equipment charged etc). The work areas should be set up as follows: Registration area: Registration

NB All equipment including magazines/newspapers/games must be marked MkV1FS with a black marker
Survey Interview area (one for each SI): Two chairs must be placed facing each other. Each SI must ensure that it is not possible for anyone to listen to conversations that will take place in the survey interview area.
Laboratory area: Laboratory Table: Cover the table with the plastic bench cover and swab the cover with disinfectant. Lay out the equipment needed for taking and processing the blood and urine samples.
The lab room must have a screened area so that the participants who are waiting cannot see you at work.
The VCT counsellor area: Two chairs must be placed facing each other. Ensure that it is not possible for anyone to listen to conversations that will take place in your counseling area.
Set up your laboratory testing equipment on a table that has been covered with a plastic bench cover.
The Clinician area: Two chairs must be placed facing each other. Ensure that it is not possible for anyone to listen to conversations that will take place in your clinician area. -You must stay with your vehicle during repairs /services -The first AID kit must be in place and you are responsible for replacing informing the fieldwork manager about any items that need to be replaced.
-The vehicle should be cleaned/washed once or twice a week when in field. Cleaning of the engine will be done when you return to Mwanza.

5.
In the field you must handover the keys to the team leader in the evening after the working hours

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A11o_ Driver SOP (04Jan08).doc 2 6. You must keep proper records on the vehicle, including filling in the logbook after every journey, keeping receipts for fuel and lubricants purchased for the vehicle, repairs, etc. You should let the Fieldwork Manager know when the vehicle is going to need its next service.
7. You must ensure that the vehicle has enough fuel for the journey and when you refuel the vehicle you must fill both tanks.
8. You should report to the supervisor/team leader any problem concerning with vehicle 9. You should follow all the instruction as assigned by the team leader, field supervisor, fieldwork manager and/or project co-ordinator. You should cooperate with all staff working on the project 10. While at the field site you should make sure that the vehicle is kept at the safe place (Team Leader must make decision regarding the car parking place).
11. The vehicle should only be used for official duties. If you are found to have been using the vehicle for private use, you will be fined TSh 50,000 and given a written warning on the first occasion, and will be fined TSh 50,000 and dismissed on the second occasion. The fines will be deducted from your monthly salary payments from the project. You must sign a letter agreeing to these terms before being issued with the vehicle.
12. You must also report any accidents to the Field Office immediately by: a. Phoning the office (PC, FC, FS or the Project Accountants).
b. Sending a written report on the accident to the Project co-coordinator by the fastest possible means.

MEMA kwa Vijana Trial Further Survey (2007-2008)
MKV1FS Prot A11p_FS SOP (09Jan08).doc 3. Look through the previous supervision reports to remind yourself of outstanding issues and procedures/staff members that you need to supervise closely. 9. Visit some of the Vitongoji leaders/ Balozi in villages already mobilized to see that they are aware of the project and that they have the correct information.

MKV1 FS: Standard Operation Procedures for Field Supervisor
10. Visit a random selection of households in areas that have been mobilised to see whether the household head has received the project information sheet.
11. At the end of your visit give the MO feedback, praising the good work and giving advice, if necessary, on how they can improve their mobilisation activities.

Census-field supervision
12. The day you arrive you will meet with the census TL. The CTL will give you a brief update on the progress of the census together with good things and challenges encountered. Meet also with the whole census team to hear how they have been getting on and to encourage them to continue their good work.
13. When in the field, go at least with two CIs in the field to observe how they do their work. You should randomly select the CIs that you will observe and you should not involve any staff including the CTL in this activity.
14. You should also make repeat visits to at least two HH from each category i.e.

MkV1 FS: STI Treatment SOP
(1) One week before departure make sure that you have information on the community that you will be visiting ie list of villages, sub villages, participants to be treated and contact details of community leaders. You should make a provisional fieldwork plan indicating the number of days that you will need to work in the community. This plan should be discussed and finalised with the FC/PC/FS at least 2 days be fore travelling.
(2) Ensure that all required field documents letters; equipments, drugs and other supplies are well-packed 2 days before STI treatment trip.
(3) District Capital: Travel to the District capital on your way to the community / ward pass the district capital and greet the DMO, DED and MkV2 TA. Discuss with the DMO that you are in the District to treat MkV1 FS participants who tested positive for NG, CT, and syphilis and who were not treated syndromically during the survey. Explain to the DED that you are in the District to follow-up with some clients who participated in MkV1 FS but do not specify that you will be treating clients for STI.
(4) Ward capital: On the same day report to the WEO a. Explain that you are following up some clients who participated in MkV1 FS. b. Do not specify that you are treating for STI but say that you are collecting some information from some of the clients that we already interviewed. c. Ask the WEO to help you to identify the villages with health facility either a dispensary or health centre ( MKV1FS PROT A11Q_STI TREATMENT SOP. DOC 2 b. If client is there then have a private meeting with the client and if they agree treat them as necessary for chlamydia or gonorrhoea OR invite them to the health facility to be treated for syphilis (see details below). If you invite a client to the health facility tell them that you will give them transport costs for the journey when they arrive at the health facility (up to a maximum of 2,000/= for a return journey). Give an appointment date and time after discussion with the client. c. If the husband or wife of the STI positive client is at the household have an informed consent signed and then treat them. If one or both of them don't consent, give the client referral slips for partner (s) and explain where they can go for treatment. d. If client is not present make an appointment to return to the household OR if this is not possible within the time that you have in the community then let them know when you will be in specific health facilities and invite them to come and see you there. e. If client is travelling for some time and you will not be able to see him/her during your visit to the community you should leave a note for the participant and a referral slip for that client and request that they go to the health centre in the ward capital. Also leave referral slip at the clinic explaining the survey, diagnosis and date the specimen was taken.  b. Explain to them that they need to be treated for Syphilis (and/or other STI). c. If treating for Syphilis with Benz Penicillin ensure that you or health facility staff are ready to treat with adrenalin if client has allergic reaction.

MEMA kwa Vijana Trial Further Survey (2007-2008)
(8) Before leaving the community visit the WEO to let him know that you have finished your work for now. (9) One day after return to mwanza you should meet with FS/PC and debrief them about your visit to the community.

Back in Mwanza
(10) You must submit your retirement to NIMR office on the day after you return to mwanza.
(11) You must produce and submit the STI treatment report to the PC within 3 days of your return to mwanza.

Motorbike
(12) You will be issued with a project motorbike for your work. You must keep proper records on the motorbike, including filling in the logbook after every journey, keeping receipts for fuel and lubricants purchased for the bike repairs.
(14) You must ensure regular maintenance of the motorcycle and provide a written report to the field coordinator after each trip and help him to arrange the repairs.
(15) The motorbike should only be used for official duties. If you are found to have been using the motorbike for private use, you will be fined Tsh50, 000 and given a written warning on the first occasion. You will be fined Tsh50, 000 and dismissed on the second occasion. The fines will be deducted from your monthly salary payments from the project. You must sign a letter agreeing to these terms before being issued with the motorbike.
(16) You must observe traffic regulations (e.g. speed restrictions, you must wear a safety helmet and other safety gear).
(17) You must not drive the motorbike if you have consumed any alcohol within the previous 8 hours.
(18) You must also report any accidents to the field office immediately by: (a) Phoning the office (PC, FC, FS) AND (b) Sending a written report on the accident to the project co-ordinator by the fastest possible means.

MkV1 FS: STI Treatment post-survey SOP
A. Preparation (1) Make sure that you have information on the community that you will be visiting ie list of villages, sub villages, participants to be treated (list from data section) and contact details of community leaders (survey mobilisation information).
(2) If the community has been visited before for STI treatment (by Clinician or during mopup) then cross-check lists of names/sticker numbers to be sure that clients have not already been treated or traced.
(3) Look at registration book to get names and contact details of clients who were not invited by census team ie list produced by data will only have their sticker number.
(4) You should make a provisional fieldwork plan indicating the number of days that you will need to work in the community. This plan should be discussed and finalised with the FC/PC/FS at least 2 days be fore travelling.
(5) Ensure that all required field documents letters; equipments, drugs and other supplies are well-packed 2 days before STI treatment trip.

B. Mobilisation
(6) District Capital: a. Travel to the District capital on your way to the community / ward pass the district capital and greet the DMO, DED and MkV2 TA.
b. Discuss with the DMO that you are in the District to treat MkV1 FS participants who tested positive for NG, CT, and syphilis and who were not treated syndromically during the survey.
c. Explain to the DED that you are in the District to follow-up with some clients who participated in MkV1 FS but do not specify that you will be treating clients for STI.

(7) Ward capital:
a. Meet with the WEO and explain that you are following up some clients who participated in MkV1 FS.
b. Do not specify that you are treating for STI but say that you are collecting some information from some of the clients that we already interviewed.
c. Ask the WEO to help you to identify the villages with health facility either a dispensary or health centre d. Visit the main health facility at the ward capital and meet with the doctor/nurse who is responsible for treatment of STIs. Explain that you may refer some clients to their health facility for treatment and give example of MkV1 FS client referral slip and MkV1 FS contact referral slip.

(8) In each village:
a. Meet with the VEO and explain that you are collecting some extra information from clients that participated in MkV1 FS. Do not specify that you are treating for STI.
b. Visit the health facility (if one exists) and ask the staff if you can use the facility to treat clients for syphilis and other STI. Ask him/her to help you to find a room where you can see the clients.
c. Give names of those to be traced to the tracers. Tell them that these clients are on List A.

Treatment for STI
(9) At the health facility: a. Welcome the client and confirm their identity.
b. Explain to them that they need to be treated for Syphilis, Chlamydia and/or Gonorrhoea.
c. If treating for Syphilis with Benz Penicillin ensure that you or health facility staff are ready to treat with adrenalin if client has allergic reaction.

Revisit to WEO
h. Before leaving the community visit the WEO to let him know that you have finished your work for now.

MEMA kwa Vijana Trial Further Survey (2007-2008)
MKV1FS PROT A11R_STI TREATMENT SOP POST SURVEY (20JUL08). DOC 3 Revisit to Ward Health Facility i. Revisit main health facility in the ward and leave a list of names of those who tested positive for a STI and who you did not manage to treat during the visit to the community ie those who were given MkV1 FS client referral slips.
Back in Mwanza (10) One day after return to mwanza you should meet with FS/PC and debrief them about your visit to the community.
(11) You must submit your retirement to NIMR office on the day after you return to mwanza.
(12) You must produce and submit the STI treatment report to the pc within 3 days of your return to mwanza.

MkV1 FS: Follow-up of HIV results SOP
You will revisit clients who had an initial discordant VCT result and give them the NIMR HIV result ie the result based on analysis of their serum sample at NIMR using ELISA (the samples of some clients were also analysed using p24 and Western Blot).
You will also revisit clients if the VCT result does not match the NIMR HIV result.
A. Preparation (Counsellor/ Clinician) (1) Make sure that you have information on the community that you will be visiting ie list of villages, sub villages, contact details of community leaders (survey mobilisation information).
(2) You will receive a list of sticker numbers form the data section. For each client you will be given the initial VCT result and the NIMR result.
(3) For each client cross-check the VCT results from the data section with the VCT results in the counsellor notebook. If these do not match then please contact the Project co-ordinator or Field supervisor.
(4) You should make a provisional fieldwork plan indicating the number of days that you will need to work in the community. This plan should be discussed and finalised with the FC/PC/FS at least 2 days before travelling.
(5) Ensure that all required field documents letters; equipments, test kits, serum/EDTA tubes and other supplies are well-packed 2 days before field trip.
B. Mobilisation (Counsellor/ Clinician) (6) Your visit is likely to take place at the same time as revisits to treat clients for STI (see SOP for STI treatment post survey) and you will not need to make any specific visits to the District, Ward Capital or village leaders.
(7) If STI treatment is not taking place in that ward/ village then you should meet with the WEO and then the VEO and explain that you are collecting some extra information from clients that participated in MkV1 FS. Do not specify that you are following up clients who had VCT.
C. Tracing (Tracers, Driver) (8) Give the names of clients in Category 1 (c), 2, 3 and 4 to the tracers working with you on your team. Tell them that the names of these clients are on List B. They will invite clients to see you at the health facility.
(9) Clients in Category 1(a) and 1 (b) will not need repeat testing and will not need to visit the health facility. You will be able to visit these clients yourself at their households and give them the final NIMR result and carryout post-test counselling.
b. Explain to them that we have further information for them about their VCT HIV test results.
c. Look carefully at the information provided by the data section and decide which category the client belongs to. Carry out the procedures described below for that category.
d. If you repeat VCT then you should repeat the pre and post test counselling and following the testing procedures as described in the SOP for VCT counsellor.
e. Take the printed stickers that correspond to the original sticker number of the participant. Place one sticker in your notebook and one sticker on the follow-up HIV results form. Place one sticker on the consent for VCT form.
f. If you need to take a blood sample then follow the following procedures.

Collection of Purple topped EDTA tube sample:
g. Place one sticker on the sample submission form.
h. Label with stickers two EDTA purple topped 5mL vacutainer tubes. Ensure the stickers are sealed with sellotape.
i. Explain to the client that you are going to collect blood by venepuncture.
j. Explain to him/her that there will be a small pain as the needle is inserted into the vein.
k. Apply a tourniquet above the elbow until the vein is raised. r. Release the tourniquet and then remove the needle. Put cotton wool soaked in spirit over the puncture mark and ask the client to press on the cotton wool.
s. Unscrew the needle from the holder and dispose of in a safe container/disposal bin.
t. You need to mix the EDTA in the tube with the blood that is collected by carefully turning each tube up and down 6 times. NB DO NOT SHAKE.
u. When you have mixed the contents of the vacutainer tube then store the tube between +4° to +25° degrees Celsius. DO NOT FREEZE.
v. All EDTA tubes must be returned to Mwanza within 4 days of collection. At the end of every community (~ every 3 days) one team member will travel by public transport to Mwanza carrying the samples in a carrier bag with rack for tubes inside. This bag should contain some ice packs. Samples should be brought to NIMR during working hours.
Back in Mwanza (11) One day after return to mwanza you should meet with FS/PC and debrief them about your visit to the community.
(12) You must submit your retirement to NIMR office on the day after you return to mwanza.
(13) You must produce and submit the STI treatment report to the PC within 3 days of your return to mwanza. Repeat VCT: If repeat VCT is positive then tell client that they are positive.
If repeat VCT is negative then tell client that they are negative.
If repeat VCT is discordant then tell client that it is not possible to know if they are positive or negative and that they should retest themselves after 3 months.
For all clients request the client to provide another blood sample. This blood sample will help us with our research. If they agree then collect two EDTA tubes of blood.

Category 2. Initial VCT positive-NIMR result negative
Repeat VCT. If repeat VCT is negative then tell client that they are negative and that their first VCT was a false positive.
If repeat VCT is positive then tell client that they are positive.
If repeat VCT is discordant then tell client that is not possible to know if they are positive or negative and that they should retest themselves after 3 months.
If repeat VCT is positive or discordant then request the client to provide another blood sample. This blood sample will help us with our research. If they agree then collect two EDTA tubes of blood.

Category 3. Initial VCT negative-NIMR result positive
Repeat VCT. If VCT is negative then tell client that they are negative. If VCT is positive then tell client that they are now positive and their first VCT was a false negative. If VCT is discordant then tell client that is not possible to know if they are positive or negative and that they should retest themselves after 3 months.
If repeat VCT is negative or discordant then request the client to provide another blood sample. This blood sample will help us with our research. If they agree then collect two EDTA tubes of blood.

Category 4. Initial VCT positive-NIMR result indeterminate
Repeat VCT. If VCT is negative then tell client that they are negative and that the first VCT result was false positive. Recommend that they get retested after 3 months. If VCT is positive then tell client that they are positive. If VCT is discordant then tell client that is not possible to know if they are positive or negative and that they should retest themselves after 3 months.
For all clients request the client to provide another blood sample. This blood sample will help us with our research. If they agree then collect two EDTA tubes of blood.

MkV1 FS: Tracing Post-survey SOP
a. The clinician and/or counsellor will give you names of clients to be traced. Write these names onto your tracing form.
b. The clinician and/or counsellor will tell you if these clients are on list A or list B. Write A or B beside the name of the client on your tracing form.
c. It is very important that no one in the communities that you are visiting know that you are following up young people who have laboratory results that we need to discuss with them.
d. Meet with the Kitongoji leader and explain that you have some things to discuss with clients that participated in MkV1 FS. Ask the Kitongoji leader to help you to identify the households of the clients that you need to invite to the health facility.
e. At the household, confirm the identity of the client.

List A clients:
a. If client is there then have a private meeting with the client and explain that we would like them to attend at the health facility.
b. Remind them that we promised to return and treat clients who tested positive for syphilis, Chlamydia or gonorrhoea.
c. Give an appointment date and time after discussion with the client (MkV1 FS CLIENT INVITATION SLIP).
d. Tell them that you will give them transport costs for the journey when they arrive at the health facility (up to a maximum of 2,000/= for a return journey).
e. Tell them that their partner (s) can attend with them and if they do so then they will also benefit from free treatment for STIs (if necessary).
f. If client is NOT there then leave invitation for them to come and see you at the health facility (MKV1 FS CLIENT INVITATION SLIP).
g. If client is travelling and you will not be able to see during your visit to the community you should fill out a MOVED AWAY FORM for the client. Leave a referral slip for that client and request that they go to the health centre in the ward capital (USE MKV1FS CLIENT REFERRAL SLIP).
h. Before leaving the household indicate one your tracing form if the client was found and given invitation. If you filled out a moved away form or client referral slip then please indicate this on the tracing form.

List B clients:
a. If client is there have a private meeting with the client and explain that we would like them to attend at the health facility. b. Remind them that we are returning to clients who had a VCT HIV result that was not clearly positive or negative OR where the result of VCT is different from the result found at NIMR.
c. NB Bring the client immediately with you to the health facility.
d. If they are not able to go with you immediately then give an appointment date and time after discussion with the client (MkV1 FS CLIENT INVITATION SLIP).
e. Tell them that you will give them transport costs for the journey when they arrive at the health facility (up to a maximum of 2,000/= for a return journey).
f. If the client is NOT there then make an appointment to return to the household and leave a message saying when you will be in specific health facilities and invite them to come and see you there (MKV1 FS CLIENT INVITATION SLIP).
g. Before leaving the household indicate one your tracing form if the client was found and given invitation. If you filled out a moved away form then please indicate this on the tracing form.

MKV1 FS: Standard Operation Procedures for Census Checker (CC)
1. Make sure that you have the census timetable at least one week before the field trip.
2. One week before leaving for the field make sure that you have the correct and current version of both the SOP and the Protocol, read them carefully and follow the instructions while working/in the field.
3. One week before the field trip check that you have all required equipment (e.g.

PDAs, GPS), documents and other supplies (Census Team Packing List). If
there are any problems with the equipment then inform the CTL.
4. Two days before travelling, collect your imprest from the Project administrator. 6. On the day of departure, you will leave NIMR, Mwanza early in the morning so as to arrive in the survey community (ward capital) in the afternoon/early evening.
All travel to the field must start at NIMR, Mwanza.
7. The day after arriving in the community (Day 1) you must: a. help the CTL with preparations for the census.
b. Pack your bag for Day 2, double-checking that all equipment is working and that you have the necessary forms for your work the following day.
Where possible carry with you extra copies of necessary forms and sheets.

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A11u -SOP Census checker.doc 2 c. Attend the briefing meeting that the CTL will hold at the end of Day 1 and carefully note the kitongoji and CH assigned to you. 11. If there is nobody at the household when you visit then enter 2 = "absent" on the column of census status for this household. Make a maximum of two further attempts to visit that HH later in the day (visits on the same day must be at least 4 hours apart) or on the next day and complete the columns of census status for this household. Record the date and time of each visit (Swahili time) on your CI form for HH head. If possible, leave a message with the neighbours to say that you will be returning at a specified time. The same CI form for HH head will be used for all days in the same kitongoji.

MkV1FS Protocol
Codes for CI form a. If the HH were not interviewed by the CI and you find the young person then ask the household head (and other HH members) to provide the necessary information about the young person. Give all eligible young people you find in the HH which were not interviewed a survey invitation by writing on a sticker note (not a green survey invitation).
b. If the young person is not present then leave a survey invitation at the household.
c. If the eligible young person will not be able to attend the survey because they are travelling for a long period of time/ have moved away to study etc. then fill out the moved away form but still leave an invitation.
Indicate on the CI form for HH head that you have left a moved away form (Please write M to the left of the name of the Household head on the CI form). You must submit used moved away forms to the CTL at the end of each day.

If the eligible young person is aged 17 years or younger then you must leave a copy of the Information sheet for parent(s)/guardian(s). You must also leave an Informed consent sheet for parent(s)/guardian(s).
If the parent/guardian is present then ask them to sign the informed consent sheet (read first to them the information on the IC sheet). Signing of the IC sheet must be witnessed by the kitongoji leader or the community helper (must also sign the form). If the parent/guardian is not present or will not immediately sign the IC sheet then inform the HH members that the invited YP who is <18 yrs of age must take the

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A11u -SOP Census checker.doc 4 survey invitation AND the IC sheet to the survey. You must submit completed IC sheet for parent/guardian to the CTL at the end of each day.
14. You should use the calendar of events to help the respondents recall dates.
15. At the end of the day: a. Attend the daily debriefing meeting and share your experiences with the rest of the team.
b. By using rotary method select the CI whose previous HH you will visit the next day, one CI will pick the piece of paper on which the staff code of the CI is written.
16. When requested you must assist the CTL with other census tasks e.g.
synchronisation, burning of CDs, generation and printing of lists.

SOP for Tracing during Mop-up DRAFT 06 June 08
There are 3 pieces of information that we will use during Mop-up: A. List of households not interviewed B. List of invited young people who did not attend C. Master list of all those who did not attend including those not invited The Team Leader will assign you to one or more kitongoji.

Households:
(i) Write head of household names from the 'mop-up list of households' onto your CI form. (ii) Visit all households on your CI form and complete the PDA/back-up census questionnaire. (iii) If a potentially eligible young person is identified (and has not already attended) then you should give them an invitation to attend the survey site. Try to bring them immediately to the survey site and/or make an appointment for the vehicle to collect them. (iv) Fill out a moved-away form if the young person is absent.

Young People:
(i) Transfer names of young people to be traced from the Master List and/or the List of invited not attended (L1/L2) onto your tracing form. (ii) Visit the households of the young people on your tracing form. (iii) If you find a young person then invite them to the survey site. Try to bring them immediately to the survey site and/or make an appointment for the vehicle to collect them. (iv) Fill out a moved-away form if the young person is absent.

NB Completion of moved-away forms
Ensure that you write the sex of the client (on the top right of the page) or in the space provided Ensure that you write the name of the husband/wife if the client is married For females write the name of the first child if she has had any children Get as detailed information as possible on their current location including a mobile phone no.

NB Prioritisation of females
First you should try to trace females. If you are close to the household of a male then you should also trace the male living in that household.
A. Households not interviewed B. Young people invited but did not attend C. MASTER LIST All young people who did not attend-invited and not invited

MkV1 FS: Standard Operating Procedures for Mobilisation Officers (MO)
Preparations.
1. One week before leaving for field, make sure that you have the correct and current version of both SOP and the protocol, read the carefully and follow the instructions while working/in the field.
2. Two days before travelling, collect your imprest from the Project administrator.
3. Ensure that all required field documents/letter, equipment and other supplies are well-packed 2 days before mobilisation trip.

4.
When you reach at the ward capital, visit the ward official and explain to them that we are in the ward for a few days to do mop-up for the YP we didn't reach during the main survey.

Visit the village officials and inform them of the team revisiting the village for
mop-up.
6. Book accommodation for the team for at least three days. 11. You must submit your retirement to the NIMR office on the day after you return to Mwanza.

Motorbike
12. You will be issued with a project motorbike for your work. You must keep proper records on the motorbike, including filling in the logbook after every journey, keeping receipts for fuel and lubricants purchased for the bike, repairs, etc.

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A11w-SOP for MO for mopup round.doc 13. You must ensure regular maintenance of the motorcycle and provide a verbal report to the Fieldwork Manager after each trip and help him to arrange the repairs.
14. The motorbike should only be used for official duties. If you are found to have been using the motorbike for private use, you will be fined TSh 50,000 and given a written warning on the first occasion, and will be fined TSh 50,000 and dismissed on the second occasion. The fines will be deducted from your monthly salary payments from the project. You must sign a letter agreeing to these terms before being issued with the motorbike.
15. You must observe traffic regulations (e.g. speed, you must wear a safety helmet and other safety gear).
16. You must also report any accidents to the Field Office immediately by: a. Phoning the office (AD, KM, LM or the Project Accountants).
b. Sending a written report on the accident to the Project co-ordinator by the fastest possible means.

SOP for Preparation of Lists for Mop-up 06 June 08
There are 3 pieces of information that we will use during Mop-up. A. List of households not interviewed (will be prepared in the office if possible) B. List of invited young people who did not attend (prepared in the field) C. Master list of all those who did not attend including those not invited (prepared in the field)

A. Lists of Households to be visited
Needed: CI form, Master list of HH heads, blank mop-up household head list 1. Choose a Kitongoji. 2. Compare the Master list of HH heads to the CI form to see that every household has been listed on a CI form. If there are households that were not on CI form then put on mop-up list of household head. 3. Look at CI form to see which HH were absent on last visit ie '2'. List these households on the mop-up list of household head. 4. Repeat procedure for next kitongoji.

B. List of Invited and didn't attend
Needed: List of invited not attended (L1 males and L2 females), list A1 and A2, lists L11 and L12, Tracing forms, Highlighter pens 1. Choose a village. 2. Obtain list L1-L2 (list of young people who were invited but who didn't attend) from data section 3. Cross-check list L1-L2 against list A1-A2 for that village to see if any of the young people have attended (use name and census ID no.). If young person has already attended then write 'ATT' in front of her name and write the sticker number beside her name.

Information Sheet for Officials & Community Members
The MEMA kwa Vijana Programme is a collaborative project of the government of Tanzania  During 2007 and 2008, the programme will conduct a survey to assess the impact of the intervention 'MkV1 Trial Further Survey'. From previous surveys that were conducted between 2000 and 2002, we already know that the MEMA kwa Vijana intervention improved the knowledge and some reported sexual behaviours in young people in your community. This further survey will tell us if these improvements have been sustained, and whether the intervention has been effective in reducing the spread of HIV and other sexually transmitted infections in the longer-term. The information that we collect will help us to find the best ways to reduce the spread of HIV and other sexually transmitted diseases in your community.

Survey Procedures:
The survey will have two parts: (1) a census of all households in the selected wards and (2) the main survey in which young people who are identified during the census will be interviewed. With help of a Project Information Officer and local leaders, information on the days of the census, as well as information on the purpose and procedures of the census and main survey, will be sent in advance to each of the sub-village leaders.

First activity (Pre-survey and preparation for census)
The MEMA kwa Vijana Project's Information Officer will visit each survey community before the census team. He will meet with district, ward, village, and sub-village leaders and explain to them the importance, purpose and timing of the census and main survey, ask for their cooperation and request permission to proceed. Each sub-village leader will be asked to help with the census by providing a list of all the households in their sub-village. This list can be compiled with the assistance of other leaders in the sub-village. They will also be asked to indicate whether there is any young person between the ages of 15 and 30 years who is currently resident in each of these households. The information officer will provide a special form for this list and will indicate the day that he will return to collect the completed list of households.

Second activity (Census)
The census team will arrive in each community. They will have obtained the list of households from the Project Information Officer. With the help of the sub-village leaders, team members will visit each household in the sub-village. They will provide the most senior adult in the household verbal and written information about the survey and obtain their permission for the household to participate in the census. This "household head" will then be asked some questions about the sex and age of all those currently living in the household. This information will be entered directly into a tiny computer. If there is any young adults aged 15-30 years living in the household, further questions will be asked to check their age and attendance at primary school in order to identify if they are eligible to participate in the main survey. Only those who attended certain years of primary school will be eligible.
The census worker will give all young adults who are eligible for the main survey an invitation to attend a specific survey point (eg. a house or guesthouse) in the village 2-3 days later. They will also be provided with a special information sheet that will explain the purpose and procedures of the survey in more detail. They will be told that they will be given a small gift to compensate them for travelling to the survey point, and for giving up some of their time. If the young person is aged 17 years, an information sheet will be left for their parent(s) or guardian(s). As well as explaining the purpose and procedures of the main survey, this will ask them to instruct the young person not to attend the main survey if they do not want them to. If there are no adults present when a household is visited, the census worker will make up to two further visits to the household. If the eligible young person is temporarily absent, the household head will be requested to give the invitation and information sheet to them. If the young person has previously participated in an MkV1 survey and has an MkV1 ID card then they should bring this ID card with them to the main survey.

Third activity (Main Survey)
On the scheduled day, the survey team will set up a survey point in a guesthouse, school or rented house in the village. All the young people who have been invited to attend the survey should come with their invitation. They will be asked to go through the following procedures: 1. Registration: All young persons will be first asked about their age and attendance at primary school (years and standards attended). All those eligible for the survey (participants) will proceed to the interview stage. If a young person is found not to be eligible, they will not be interviewed but will have the opportunity to be seen by the clinician and to be offered voluntary HIV counselling and testing, and will be given half a bar of soap and Tsh 2,000/=. 2. Interview: All participants will be asked some questions about their knowledge, attitudes and behaviour related to sexual and reproductive health. 3. Biological specimens: All participants will be asked to provide a small amount of urine, and a small sample of blood. The blood and urine samples will be tested for HIV and other sexually transmitted infections, and may be tested for other infections or illnesses at a future date. A thorough explanation will be given before any specimen is taken. All procedures will be done carefully and all regulations will be observed. No one will be forced to provide a specimen.

Screening & Treatment:
A project clinician will see each participant and free treatment will be provided to those who need it. This will include treatment for any symptoms of sexually transmitted diseases, for schistosomiasis and other acute illnesses. 5. VCT: All participants will be offered voluntary counselling and testing for HIV. 6. Incentives: Each participant will be given a bar of soap and Tsh 4,000/=.

Confidentiality:
None of the questionnaires, other forms, or specimens will be labelled with the participant's name. Instead, numbers will be used. This is to make sure that only the senior researchers can know who has answered what, and who has provided each specimen. All data and results will be kept secret, and any specimens will eventually be burnt, though they may be stored for many years at the National Institute for Medical Research in Mwanza before that is done.

Participation:
We will encourage all potentially eligible young people to come for the survey. However, if anyone does not want to, we will not force them or inform anyone of this. A participant can also withdraw from the survey any time they want.

Further information:
If you would like any further information on this project, please ask the representative who has brought you this information sheet. If you have additional questions or comments after (s) he has left, please address them to:
During 2007 and 2008, the programme will conduct a survey to assess the impact of the intervention 'MkV1 Trial Further Survey'. From previous surveys that were conducted between 2000 and 2002, we already know that the MEMA kwa Vijana intervention improved the knowledge and some reported sexual behaviours in young people in your community. This further survey will tell us if these improvements have been sustained, and whether the intervention has been effective in reducing the spread of HIV and other sexually transmitted infections in the longer-term. The information that we collect will help us to find the best ways to reduce the spread of HIV and other sexually transmitted diseases in your community.
The survey has two parts: (1) A census of all households in the selected wards (2) A main survey in which young people identified during the census will be interviewed.
We are now conducting a census of all households in this ward. Your sub-village leader is helping us to visit all the households in this sub-village. We would like to ask you some questions about the people who live here in this household. We are particularly interested in young people who have been to primary school in this ward and will invite some of these young people to be interviewed in a few days time. The information that you provide for us will help us chose the right young people to invite for the second part of our survey.
If you agree to take part in this census, we will ask you some simple questions about the age and sex of those living here. We will enter this information onto small computers. This information will be kept private. The questions should take approximately 10 minutes.
We would like you to participate in this census. But, if you do not want to, please understand that we will not force you to, and that you will still be allowed to participate in other MEMA kwa Vijana Programme activities.
Do you have any questions or want me to repeat anything I have just told you? Pause to solicit questions. • Please feel free to discuss this information sheet with anyone else you may wish to consult.
• Thank you for your time and assistance.

Why is the MkV Trial Further Survey being conducted?
During 2007 and 2008, there will be a survey to assess the impact of the intervention 'MkV1 Trial Further Survey'. From previous surveys that were conducted between 2000 and 2002, we already know that the MEMA kwa Vijana intervention improved the knowledge and some reported sexual behaviours in young people in your community. This further survey will tell us if these improvements have been sustained, and whether the intervention has been effective in reducing the spread of HIV and other sexually transmitted infections in the longer-term. The information that we collect will help us to find the best ways to reduce the spread of HIV and other sexually transmitted diseases in your community.

What does the survey involve?
(1) A census of all households in the selected wards (2) A main survey in which young people identified during the census will be interviewed.

Why have I received this invitation?
We have visited your household during the census and have found out that you are eligible to participate in the second part of the survey.

What exactly will happen to me if I attend the survey?
If you come to the survey you will be asked some questions, and, if it is confirmed that you are eligible, you will be asked to provide a small sample of urine and blood.
You will not have to answer any questions or give any samples if you do not want to.
You will be able to change your mind and stop participating in the study at any time.
You will have the opportunity to visit a clinician and to receive free treatment if you need it. You will also be given the choice of having a free, confidential HIV test (VCT).

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A25a_Surv Invit (Eng 12May07).doc In the unlikely event that you are found not to be eligible for the survey, you will receive half a bar of washing soap and TSh 2,000/= to cover your travelling expenses.
If you are eligible for the survey, you will receive a full bar of washing soap and TSh 4,000/= to compensate you for your time and to cover your travelling expenses.
We hope that you will help us with our research. This is your invitation: This is an invitation for <name> __________________________________ Please come to <site> _____________________ in <village> ______________ on <day> ________________________ <Date> _________________200_ Census ID number:

What should I take with me to the survey?
It is very important that you take this invitation with you to your appointment and that you do not give this invitation to anyone else.
If you have previously participated in a MEMA kwa Vijana survey and still have the MkV ID card that you were given, then please bring that ID card with you when you come to your appointment.
If you have any other kind of ID card or a document with your date of birth or age then please also take these to your appointment.
If you already know that you will not be able to come at that time then please tell me, and I shall be happy to try to arrange another time for you.

Information Sheet about Main Survey for Parent/Guardian
The MEMA kwa Vijana Programme is a collaborative project of the government of Tanzania (the Ministry of Health & Social Welfare and the Ministry of Education & Vocational Training), the National Institute for Medical Research (NIMR), AMREF, the London School of Hygiene and Tropical Medicine, UK (LSHTM), the Liverpool School of Tropical Medicine (LSTM) and MRC Social and Public Health Sciences Institute, Glasgow, UK. The programme is working in four districts of Mwanza Region (Misungwi, Sengerema, Geita, and Kwimba). The programme supports improved treatment of sexually transmitted diseases in health facilities, provides additional training for health workers, and provides sexual and reproductive health education to primary school pupils.
During 2007 and 2008, the programme will conduct a survey to assess the impact of the intervention 'MkV1 Trial Further Survey'. From previous surveys that were conducted between 2000 and 2002, we already know that the MEMA kwa Vijana intervention improved the knowledge and some reported sexual behaviours in young people in your community. This further survey will tell us if these improvements have been sustained, and whether the intervention has been effective in reducing the spread of HIV and other sexually transmitted infections in the longer-term. The information that we collect will help us to find the best ways to reduce the spread of HIV and other sexually transmitted diseases in your community.
We have already made a census of your household, and <name> _______________________ has been selected to participate in the second part of our survey(the main survey).
As (s) he is not yet 18 years of age, we would like to ensure that you understand what will happen if he/she attends the main survey, and to let you know what you should do if you do not want him/her to participate in the survey.
When the participant arrives at the survey point they will be greeted and some of the survey staff will ask some simple questions about his/her age and where he/she went to school.
If it is confirmed that (s)he is eligible, an interviewer of the same sex as the participant will ask him/her some questions about sexual and reproductive health issues, and (s)he will be asked to provide a small sample of urine and blood.
(S)he will not have to answer any questions or give any samples if (s)he does not want to.
(S)he will be able to change his/her mind and stop participating in the study at any time.
(S)he will have the opportunity to visit a clinician and to receive free treatment if (s)he needs it.
(S)he will also be given the choice of having a free, confidential HIV test.
In the unlikely event that (s)he is found not to be eligible for the survey, (s)he will receive half a bar of washing soap and TSh 2,000/=.
If (s)he is eligible for the survey, (s)he will receive a full bar of washing soap and TSh 4,000/=.

MEMA kwa Vijana Trial Further Survey (2007-2008)
MkV1FS Prot A26a_Info Parent (Eng 12May07).doc The participants name will not be written on any of the questionnaires, other forms, or specimen containers. Instead, numbers will be used. This is to make sure that only the senior researchers can know what they have answered, and which are the specimens that they have provided. All data and results will be kept secret, and any specimens that they give us will eventually be burnt, though they may be stored for many years at the National Institute for Medical Research in Mwanza before that is done.
We hope that you will allow him/her to help us with our research. But, if you do not want them to, please understand that we will not force you to agree, and that they will still be allowed to participate in other MEMA kwa Vijana Project activities.
Also, even if you agree for them to participate now, if you change your mind, you can withdraw them from the survey at any time, or can refuse for them to give one or more of the biological specimens. • Please feel free to discuss this information sheet with anyone else you may wish to consult.
• Thank you for your time and assistance.
• Atapata fulsa ya kumtembelea mganga na kupata matibabu ya bure. infections in the longer-term. The information that we collect will help us to find the best ways to reduce the spread of HIV and other sexually transmitted diseases in your community.

Checking eligibility:
You have been invited to attend this survey. Thank-you for coming here today. First we will need to check whether you are really eligible for the main survey. To do this, one of our staff will ask you a few simple questions about your age and where you went to school.

If you are not eligible:
In the unlikely event that you are not eligible, you will not need to do anything more, but will be offered the chance to see a clinician who will check whether you have any illness and will provide free treatment if you need it. (S)he will also offer you the choice of having a free, confidential HIV test.
You will also be given half a bar of washing soap and TSh 2,000/= to cover your travelling expenses.
Your name will not be written on any of the forms. Instead, numbers will be used. This is to make sure that only the senior researchers can know what you have answered. All the data you have provided will be kept secret. If you are found to be eligible, in a few minutes, if you agree to participate, a young interviewer of the same sex as yourself will ask you some questions about sexual and reproductive health issues. You will then be asked to provide a small amount of urine, and a small sample of blood.
If you do not want to provide any of these specimens, you will not be forced to. The blood and urine will be tested for HIV and other sexually transmitted infections, and may be tested for other infections in the future. You will also be seen by a project clinician, who will provide free treatment if you need it. You can also visit the counsellor and have a free test for HIV if you want to do that.
You will be given a bar of washing soap and Tsh 4,000/= to thank you for sparing time to participate in this research.
Your name will not be written on any of the questionnaires, other forms, or specimen containers.
Instead, numbers will be used. This is to make sure that only the senior researchers can know what you have answered, and which are the specimens you provided. All data and results will be kept secret, and any specimens you give us will eventually be burnt, though they may be stored for many years at the National Institute for Medical Research in Mwanza before that is done.
We would like you to participate in all of these survey activities. But, if you do not want to, please understand that we will not force you to. Also, even if you agree to participate now, if you change your mind, you can withdraw from the survey at any time, or can refuse to give one or more of the biological specimens.

Further information:
• Does anyone have any questions or want me to repeat anything I have just told you?
• If you have additional questions or comments after we have left, you will find the name and address of the project on the paper you were given when one of us visited your home previously. Does anyone want another copy of that paper?
• Does anyone have any further questions?  4. I also know that I have the right to leave the study at any time if I do not want to continue. 5. I know that I will be offered free treatment for sexually transmitted infections today, if the clinician thinks this is needed. 6. I know that I will be offered voluntary HIV counselling and testing. 7. I am aware that all the information that I give, all the findings of the clinician, and all the results of the laboratory tests, will be kept secret. 8. I am aware that if I am found to have any curable, harmful infections when my specimens are tested later, a clinician will return to my village to offer me treatment, unless I say I do not want this on this sheet. 9. I agree to take part in this study.

No.
Name ( The risk of someone being HIV-infected after a needlestick injury from an HIVinfected source person has been estimated at 3 per 1,000. The risk after exposure to splashes or contact with other tissues is lower than this. With post-exposure prophylaxis, this risk can be reduced by 50-95%. In most of our current work (e.g. surveys of bar workers), the risk that a source person is HIV-infected is approximately 40-50%. The risk of HIV infection in other groups that we work with (adolescents, ANC attenders, community members) lies between <1-30%.
These guidelines are based on the references cited at the end of this policy.

Eligibility:
Post-exposure prophylaxis (PEP) will only be offered to staff who are exposed while carrying out duties that are directly related to the work they have been assigned by one of the NIMR/AMREF/LSHTM Collaborative Research Projects. PEP will NOT be offered to staff for sexual exposures, with the exception of rape while in the field, or exposures while carrying out private duties or duties that have been assigned by another institution.

Prevention:
All staff working for the NIMR/AMREF/LSHTM Collaborative Research Projects who handle potentially infectious materials (especially human blood) should receive a copy of this policy document. All such staff should receive guidance on how to avoid needlestick injuries and contacts with body fluids or other body tissues, and the importance of receiving immediate first aid if they do have such an injury/contact. This is being incorporated into the training seminars for the collaborative project staff on good clinical and laboratory practice.

Reporting for assessment and advice:
All staff should report incidents in which they have been exposed to needlestick injuries or a contact with body fluids or other body tissues immediately to one of the following PEP supervisors: • Dr Saidi Kapiga, MITU Director, NIMR Mwanza Centre • Joseph Masanja, Acting Mwamko Project Manager.
If neither of the PEP Supervisors is available, one of the other medically trained officers working for the NIMR/AMREF/LSHTM or MITU Projects should be contacted (e.g. currently Mary Rusizoka, HSV).
If the incident happens when working outside Mwanza City, this should be done through their Team Leader, or whoever is the most senior staff member with them (see below).

Assessment:
The PEP supervisor should start to complete a PEP Report Form (Annex 1:Section A). They should assess the risk of exposure to infection and the need for prophylaxis using the following guidelines: •

Needlestick injury:
Recommend PEP in all genuine cases. • Mucosal contact (e.g. mouth or eyes): Offer PEP if there was contact with blood or constituents of blood (e.g. serum/plasma), or was with untreated tissue (e.g. fresh vaginal swab material/semen). Do not offer PEP if the contact was with other body fluids (e.g. urine).

• Skin contact:
Only offer PEP if there is an obvious portal of entry (e.g. a wound or ulcer) on the skin of the exposed person, or there was extreme contact with the blood or other untreated tissue (e.g. a major splash with blood). Do not offer PEP if there is no obvious portal of entry and the exposure was brief.
• Rape: If a staff member is raped while on field assignment for the collaborative projects, and there has been penetrative vaginal and/or anal intercourse, then they should be offered PEP. PEP should also be offered if there was any risk of oral mucosal contact with semen. • Time since incident: If less than 4 days (i.e. <72 hours) have elapsed since the exposure incident, prophylaxis should be considered. If 4 days or more (>72 hours) have elapsed since the exposure incident, prophylaxis should not be considered. However, pre and post test counselling and baseline HIV testing and HIV testing at 6 weeks, 3 and 6 months should be performed with the consent of the exposed person.
The exposed person should immediately wash wounds with soap and water; flush mucous membranes with water.

Prophylaxis:
If the results of the assessment indicate that it is needed and the exposed person accepts it, prophylaxis should be started immediately with a single dose of both zidovudine (ZDV) and lamivudine (3TC) and nelfinavir (NFV): • Immediately after giving the first emergency dose of PEP, the need for an HIV test should be discussed, and full pre-test counselling given. The subject should be reassured that the results of the test will be strictly confidential between themselves and the PEP Supervisor who will give them post-test counselling. The test results will not affect their employment. However, prophylaxis will not be continued unless the HIV test is accepted.
If the HIV test is accepted, prophylaxis should be continued with: • Zidovudine 250mg twice per day and Lamivudine 150mg twice per day P.O.
• Kaletra 2 tablets P.O. twice per day (i.e.400mg lopinavir + 100mg ritonavir b.d.) swallowed whole The full course of PEP is 4 weeks (but see Section 7 for the rules about continuing or stopping prophylaxis depending on the HIV test result). They should read and given the PEP Patient Information Sheet (Annex 2). The drugs should be taken with a light meal or snack to ensure adequate absorption of nelfinavir.
Side effects: diarrhoea. This can usually be managed conservatively with antidiarrhoeals. ZDV-associated anaemia is unlikely within 4 weeks of treatment unless the exposed person already has anaemia. If this is the case, an alternative regimen will be chosen once baseline blood tests have been checked. Increased total cholesterol and GGT are noted on laboratory testing. Other possible minor side effects with Kaletra include insomnia and headache.
Rarely Kaletra can cause pancreatitis. This is more common in people with preexisting liver disease.
Kaletra also interferes with the oral contraceptive pill and reduces its effectiveness. In any event, whether the exposed person accepts HIV-testing or not, they should be encouraged to abstain from sex or to use a condom consistently during the first six months after exposure.
PEP supplies are held by Dr Saidi Kapiga and Joseph Masanja. A 3 day PEP starter pack is also held by the MkV FS field teams, under the supervision of the clinician working in each team.

HIV Testing:
Blood from both the source person and the exposed person should be tested for HIV as soon as possible after the incident. The source person should receive full pre-test counselling, and has the right to refuse to be tested. The importance of maintaining confidentiality for the exposed person is paramount. The PEP Supervisor is responsible for ensuring that the serological testing is done and reported promptly, and that the confidentiality of both the exposed person and the source person is maintained. This should be done by assigning a code to each person.
The decision to continue or stop prophylaxis should be based on the following:

MkV1FS Protocol
• Exposed person HIV-positive: Stop prophylaxis • Exposed person and source person are HIV-negative, where source person is from a low risk group (adolescents, ANC attender): Stop prophylaxis • Exposed person and source person are HIV-negative but source person is from high HIV incidence risk group (e.g. barworker) where early HIV infection cannot be excluded: Continue prophylaxis for a total of 4 weeks • Exposed person is HIV-negative and source person is either HIV-positive or cannot be tested: Continue prophylaxis for a total of 4 weeks.

Documentation:
The PEP Supervisor should complete a PEP Report Form and file this in a locked cabinet. They should cover the names of both the exposed person and the source person with opaque paper and photocopy the form as soon as they have completed Section A. This will create an "anonymised" PEP Report Form. As soon as possible after the incident, the PEP Supervisor should copy the anonymised PEP Report These people should then meet with the PEP Supervisor to discuss the incident (anonymously) and to make recommendations of any steps that should be taken to avoid such incidents in future.
The PEP Supervisor is encouraged to discuss the incident (anonymously) with the other PEP Supervisor if they think there is any difficulty deciding what to do: e.g. if the exposed person is pregnant.

Follow-up:
The exposed person should be encouraged to have further counselling and HIV testing, following Tanzanian guidelines, at 4 weeks, 3 months and 6 months after the incident to document any sero-conversion.
The exposed person should be seen by the PEP Supervisor and assessed clinically at 2 weeks and at 4 weeks if they are receiving PEP to assess their clinical and mental state, with particular assessment of potential drug-related side effects. Common drug-related side effects are: nausea, vomiting, diarrhoea, tiredness and headache. At baseline and at 2 weeks, blood should be taken for full blood count and for renal and liver function tests (if possible) to monitor for drug toxicity. The exposed person should be encouraged to abstain from sex or to use a condom consistently during the first six months after exposure. Condoms should be provided by the PEP supervisor. They should be informed that they should not act a blood donor for the first 6 months after exposure. Staff in such a team must report any incident to their Team Leader and the Field PEP clinician. If it is possible for this clinician to consult one of the PEP supervisors within 2 hours of the incident to seek advice (e.g. by phone), they should do so. If this is not feasible, the Field PEP clinician should make the assessment and recommend or offer prophylaxis if this is indicated (see above)

Staff working away from
. They should open one of the PEP starter packs and immediately give the exposed person a stat dose of: • Zidovudine 250mg and Lamivudine 150mg (Combivir) P.O.
• Kaletra 2 tablets P.O. (i.e.400mg lopinavir + 100mg ritonavir) The Field PEP clinician and Team Leader should instruct the affected staff member to return to Mwanza immediately to seek further advice and treatment (if needed) from one of the PEP supervisors, and should make arrangements for this (e.g. by providing a project car). While they are making these arrangements, the exposed person should be continued on: • Zidovudine 250mg and Lamivudine 150mg twice daily P.O.
• Kaletra 2 tablets P.O. twice per day (i.e.400mg lopinavir + 100mg ritonavir b.d.) swallowed whole The exposed person should be sent to Mwanza with the blood specimen of the source person (if obtained), the blood specimen of the exposed person, and the PEP Report Form in a sealed envelope addressed to both of the PEP Supervisors by name (i.e. Dr Saidi Kapiga or J Masanja). The envelope should be clearly marked URGENT, and both the exposed person and the driver must be told that the envelope must reach one of the two people immediately on arrival in Mwanza (even if this is in the middle of the night). If neither of the PEP Supervisors is available, one of the other medical officers working for the NIMR/AMREF/LSHTM Projects should be contacted (e.g. currently Mary Rusizoka).
Staff members must NEVER act as their own clinician.
If the incident happens outside Mwanza City and the staff member is not part of a team with a clinician (see above), they must return to Mwanza immediately to report to one of the PEP supervisors. However, if the nearest PEP is with one of the other collaborative project teams out in the field, they should go to the team as soon as possible to collect the first dose of PEP before travelling onto Mwanza.

11.
Other regimens: In the event that the PEP packs provided by LSHTM have been used and it is necessary to purchase PEP locally, alternative 28 day regimens are either: Although IDV is recommended as the first-line protease inhibitor for PEP in Tanzania, poor tolerability has been reported.
EFV is currently listed as the first-line protease inhibitor in Tanzania for the management of HIV-infection. The most common side effects with this regimen are EFV-associated CNS effects. For this reason EFV should be taken at night before going to sleep. EFV should NOT be given in 1 st trimester of pregnancy because of potential teratogenic side effects.

12.
PEP in pregnancy: The regimens for exposed pregnant staff members in Mwanza should be either a 28 day course of: The most common side effect with this regimen is NVP-associated rash. If mild/moderate continue tablets. If severe, stop NVP. This will need to be purchased as the PEP coordinators do not stock NVP.

Summary:
Immediately: • Assess exposure and administer first aid • Ask what other drugs the exposed person is taking • Give first dose of PEP • Encourage counselling and HIV testing (unless the exposed person agrees to testing, prophylaxis cannot be continued) • Take blood from both the source person and the exposed person for HIV testing • If outside Mwanza City: Send the exposed person with their own blood specimen and that of the source person (in vacutainers) and the PEP Incident Form to one of the PEP Supervisors in Mwanza. • Ensure the HIV testing is done as quickly as possible.

Baseline:
• HIV ELISA x 2, Clinical assessment and blood for full blood count, urea & electrolytes, and liver function tests 1

Annex 2: Patient's Information Sheet
You have sustained an injury that may have exposed you to HIV infection. We are giving you medicines that will help to reduce your chances of getting HIV infection by more than 80%. It is important that you read and understand the following information.
The full course of treatment is 4 weeks. The treatment may need to be taken 2 times a day. The doctor will explain when you should take the tablets and whether you should take them with food. If you have any problems while taking the medicine we give you, please come back and see the doctor. These problems may include diarrhoea, rashes, vomiting, abdominal pain or tiredness.

IMPORTANT
You must use condoms or abstain from sexual intercourse until we have checked you for HIV infection after you have finished the medicines. This is because: • You may be infectious to your partner • You may catch HIV from a partner • You may have been given medicine that may harm a baby if you get pregnant • You may have been given a medicine can interfere with the oral contraceptive pill so that it no longer works to prevent pregnancy. The oral contraceptive pill will work again once you have finished the medicine we have given you. The doctor will advise you about this.
If you have any questions or concerns, please ask us about them now.
If you have any problems on the medication, you should contact one of the doctors listed below, either in AMREF or the following telephone numbers:

Annex 3
Annex 3 HIV test form

HIV TEST RESULT FORM
Please give patient the following information about the voluntary HIV testing service. As you were told earlier, all the information and the results of the test on blood you have given us will be kept secret. If you decide you would like to know your HIV result, I will take a sample of blood from you. This sample will be taken back to NIMR, Mwanza, where it will be tested for HIV. Your name will not be on this sample. No one except you and myself will whose result this is. I will you an appointment to come back to collect the result. At that time I will also give you further advice and information. 1. Summary of trial design and study population

Trial design
The trial is a community randomised controlled trial of the MEMA kwa Vijana (MkV) adolescent sexual and reproductive health intervention (ASRH). In this trial, 20 rural communities were grouped into three strata that were expected to have a high risk (6 communities), medium risk (8 communities) or low risk (6 communities) of HIV and other STIs based on an initial community-based survey. Half the communities in each stratum were randomly selected to receive the intervention, the others acting as control communities.

Hypothesis
In the longer-term, the MEMA kwa Vijana (MkV1) Intervention leads to an improvement in sexual and reproductive health.

Study population
The study population consists of consenting young adults who are de jure members of a household in one of the 20 trial communities in rural Mwanza AND who attended at least one year of standards 5, 6 or 7 in one of the trial primary schools between 1999 and 2002.

Exposure variable
Eligibility depends on attending an MkV study school (either Intervention or Comparison) in Standards 5-7 for at least one year during the period 1999-2002. Study arm will be assigned according to the first such school attended in Standards 5-7 during that period (Exposure 1 in Table 1.1).
A sub-analysis (Exposure 2 in Table 1.1) will look at impact of the intervention on those who were interviewed in 2007/08 in their original community ie their community for exposure 1. We will carry out a sub-analysis of those who had MkV1 FS interview in their 'original' community ie community where they first went to primary school in the correct years (see exposure 1). Those who attended more than one school in the same community or trial arm will be included and classified by the first school attended. 'Crossovers' ie those who had years of schooling in both trial arms will be excluded.

Trial outcomes
The impact of the intervention on predefined primary and secondary outcomes will be examined (Tables 1.2-1.5). The trial is powered to look at primary outcomes individually for each sex but is also likely to have adequate power to look at secondary outcomes individually for each sex.

Potential Confounding Factors and Effect Modifiers
All analysis will be stratified by sex.
We will adjust for confounders only if there is a substantial imbalance between trial arms. We will only adjust for indicators that are not on the causal pathway. A-priori we will adjust for: Age group Tribe Stratum Subgroup analysis will be carried out for the following indicators which are known effect modifiers: Age group at further survey Marital Status Level of exposure to the MkV intervention (years in trial school, std5 -7, 1999-2004) Years since left trial primary school  Std 5-7 (1999Std 5-7 ( -2004

Description of census and survey recruitment
A flow chart will be drawn to show how many of the potentially eligible young people identified during the census attended and were eligible/ non-eligible and how many attended and participated by sex (see Table 2.1).
The proportion of invited young people who attended the survey will be examined by community (census dataset: ward_name), sex (census dataset: sex) and age group (census dataset: dob, yob, age) to identify any possible bias or under representation of sub-populations.

Description of cross-sectional sample
This analysis will involve all those who fulfil the eligibility criteria and who participate in the survey ie Elig ppt • The following socio-demographic variables will be tabulated by sex and Arm of trial (Intervention, Comparison): Age, Marital Status, Religion, Tribe, Highest level of Education.
• Any of these variables for which there is a substantial imbalance between arm will be noted so that final analysis can take this into account. This assessment will not be based on the results of significance tests, and p-values will not be shown.
• The following socio-demographic variables will be tabulated by sex and Arm of trial (Intervention, Comparison) but will not be adjusted for in analyses: Occupation, Male circumcision.

Statistical methods
• Analysis of this stratified cluster randomised trial will follow a two-stage approach: o In the first phase a summary measure is obtained for each cluster. o At the second stage the two sets of cluster-specific measures are compared using a stratified t-test with 14 degrees of freedom. • The number of individuals excluded may differ for each analysis eg result for the test/question not available for that individual • If a similar effect of the intervention is seen in males and females then the impact on both sexes will be examined. This will be done for primary outcomes only.

Unadjusted analysis
Within each sex, the overall prevalence for each community will be calculated and presented according to trial strata and arm. Risk ratios and 95% CIs will be calculated using the method described by Hayes & Moulton for stratified cluster randomised trials. For continuous outcomes eg age at first sex, the overall mean/median for each community will be calculated and community means/medians will be shown by strata and arm. As we have equal numbers of communities within strata in each arm, the log risk ratio is equal to the difference between the means of the log risk in each arm. The stratified t-test will be used to carry out a significance test of the null hypothesis of no intervention effect, and to obtain a confidence interval of the parameter of interest.

Adjusted analysis
Covariate adjustment will be achieved through a two-stage procedure as described by Hayes & Moulton. In the first stage, the expected number of events will be computed by fitting a logistic regression model to the individual level data. This model will include terms for stratum and pre-defined adjustment factors, but not study arm. The adjusted risk ratio (RR) and 95%CI will be obtained using methods as above, but based on the community log (O/E).
For outcomes with zero cases in some communities, or a log transformation is clearly inappropriate, unadjusted and adjusted RR will be obtained as the ratios of arithmetic mean prevalence O/E, and approximate variances and CI will be obtained

Sub-group analyses
Effect-modification of intervention arm with the following factors will be assessed using the method of Cheung et al (TMIH 2008 13:2:247-255): -Age group at further survey (categorical) -Marital status (binary) -Estimated potential number of years of exposure to the intervention (trend) -Estimated number of years since leaving school (trend) For the binary variable (marital status), we carry out a t-test to compare the difference in prevalence within each community between arms. To assess effectmodification of dose-response for the other variables, we extend Cheung's method by using linear regression to estimate the dose-response for each community, and conducting a t-test of the regression coefficients between arms. These analyses will be conducted for the adjusted RR (i.e. outcome is log O/E).  Table 2 shows that the provisional prevalence of HIV in the first eight comparison communities is slightly lower than expected in both males (1.6% vs 2.0%) and females (3.7% vs 5.0%), whereas the prevalence of HSV2 has been roughly as expected (23% vs 25% in males, 41% vs 35% in females). Active syphilis prevalence is also much lower than estimated (2.7% vs 6.5% in males, and 4.5% vs 10.0% in females). There were no specific estimates for CT and NG prevalence, but CT was expected to be much lower than syphilis and roughly similar to HIV, with NG lower than this. of all samples) have been counted as negative. It is possible that some of these discrepant samples will eventually prove to have been HIV positive.
All NG positives will need to be confirmed by a second, independent PCR test, and some may end up with a final result of being negative Overall, all these results should be considered highly provisional, and confidential A simple analysis of the MkV1 2001-02 mopup data shows that a higher proportion of females and ever married were found during mop-up when compared to the main survey (Table 4). There is some indication for both males and females that those interviewed during mop-up were at higher risk of STIs, but in general numbers are too small to draw any definite conclusions.

Aim of Mop-up
To increase the number of eligible females interviewed during MkV1 FS in order to increase the power of our study to detect a difference in HIV prevalence and to decrease potential bias in our sample selection.

(i) Reminder of relevant protocol procedures
Census: House to house census was carried out to identify young people (YP) who might be eligible to participate in MkV1 FS (700-900 YP invited per community). These potentially eligible YP are all invited to attend the survey, irrespective of whether they are currently present or not. If the household head reports a young person who is eligible to be invited to survey but who has moved away, then the census interviewer leaves an invitation for that YP but also fills out a Moved-Away Form (recording information on whereabouts of YP and their contact details).

Survey:
The eligibility of YP is confirmed at the survey site using a list of those enrolled in MkV1 in 1998 or a list of Std 7 students for trial schools in the subsequent years (2002, 2003 and 2004). Tracers go back to the households to try to find invited YP who did not attend the survey. If the household head or other community member reports that the YP has moved away then the tracer will fill out a moved-away form.
In the most recent communities, the survey team leader has been visiting secondary schools to see if there are any YP there who might be eligible (ie any YP in a secondary school who did not receive an invitation from census team). During tracing, tracers occasionally find non-invited potentially eligible and they invite these YP to the survey site.

(ii) Target population for mop-up
During the mop-up we will primarily target females but if we meet males who are eligible then they will also be interviewed. The females that we did not interview fall into three target populations ( Figure 1, Table 4): 1. Females invited without moved-away form.
2. Females invited with moved-away form.
3. Females never identified during census or survey.

Figure 1 Target populations for mop-up (iii) Target sample size
Given our current recruitment for females we would need to find another 1840 females to reach our target of 365 females/ community.
1. Invited (no moved away form): estimate 50% success in interviewing the ~50 females/ community 25 females interviewed / cmty 2. Invited (with moved away form): estimate total of ~60 females/ community with ~10 living in the community and ~ 50 at a migration point. In the community estimate will interview ~ 5 females and at the migration point estimate will interview ~ 15 females 20 females interviewed / cmty 3. Never identified: estimate total of ~ 100 females/ cmty with 20-30 living in community and 70-80 at a migration point. In the community estimate will interview ~8 females and at the migration point estimate will interview 2 females 10 females interviewed / cmty Total: 55 interviewed / community (~ 38 in the community, ~17 at migration points) 1100 additional females (~760 in trial communities, ~340 at migration points) In the above estimations we have included those identified during mop-up at the migration points as they will be identified by their community of origin. It is anticipated that both the target number of females and the number of females interviewed will vary between communities.
AD: The above figures are just rough estimations and ongoing analysis of existing census/ survey data will improve estimations of numbers of females in each of populations 1 and 2 in each community. Might get 50% (?) of those who were invited and did not attend but will depend on proportion of YP who did not attend because they were really passive refusers vs those who were busy/forgot.
Likely to be more males than females in this population (more females have MA form, more males who are invited attend) 2. Invited, with M-away 50-250 moved-away/ cmty but some of these may have attended so estimate ~ 100-150 per community and 2000-2500 for all cmtys (likely at least 50% are female) (i) Migration points with/without return to HH to collect more information Name of YP, location depends on moved-away form/ additional info collected at HH Expect <50% of those who we attempt to trace and expect that will only try to trace ~50% because we would need to restrict this to major migration points where we expect several YP to be based on Moved-Away Forms.
3. Never found 1500-2000 potentially eligible attended school in cmty probably 1000-1500 living or recently lived in cmty. have invited 700-1000 per cmty expect maximum of 300-500 per community who were never found-likely higher number of females?
(i) Return to HH not visited or not interviewed (HH absent) eg in Misasi 48 HH absent (ii) Return to community and ask trial school teachers using master list of potentially eligible (iii) Secondary schools with master list of potentially eligible (i) name of HH head and location of HH (ii) Master list (ie MkV enrolment list and Std 7 lists)-information provided by community members to allow tracing at migration points (iii) Master list (ie MkV enrolment list and Std 7 lists) (i) Could be quite successful for HH never visited or visited only once but if HH 'absent' after 3 visits then less likely will find anyone there during mopup visit-likely to find slightly more males (ii) If most eligible YP living in community have already been found then would at best get information on current location of YP ie movedaway form-more females moved away?
(iii) High if trial villages in catchment area for secondary school that has not already visited-low probability of finding in other migration pointslikely slightly more males than females in secondary schools forms will be used by the fieldworker during the mop-up and annotated in a different colour pen with additional information provided at the household.
List of YP to be invited to the survey site to visit the clinician (by kitongoji) This list will be generated from the survey database and will include those who need to be treated for CT, NG and Syphilis and an additional 20% of young people who will be interviewed by the clinician about their experience of the trial eg if 30 YP in the community to be treated then 36 YP will be invited.
The standard operating procedures (SOP) will be similar to those the teams have been using in the further survey. However, revised moved away forms, tracing forms and revised SOP for registration interviewer and tracers will be produced for use by the mop-up teams.

(vi) Official permissions and clearances
Official permissions have already been obtained to work in the 4 original trial districts (Geita, Sengerema, Missungwi and Kwimba).
MkV1FS senior staff will visit the RAS office to talk about the Mop-up and the need for further work in non-trial districts. They will request the RAS to write a letter introducing MkV1 FS to the District Executive Directors (DED), District Medical Officer (DMO) and the District Education Officers (DEO) in the districts that did not participate in the trial ie districts where migration points are situated.

(vii) Pilot study
There will be no formal piloting of the study procedures as they have already been tested in the previous sweep of the communities. However, during the last village of the main survey (Katoro village) the team will test the use of the master list to identify YP and investigate the success of revisiting HH to collect improved moved away form information.
Before leaving Mwanza for mop-up the newly formed mop-up teams will receive training on the new SOPs and documents to be used during mop-up. The first mopup team will leave a few days before the other teams and will be given extra time in the first community so as to learn the best tracing techniques. Lessons learnt will be shared between teams.

(viii) Mobilisation
A mobilisation officer will travel to the first mop-up community of each team a few days before they arrive to inform the WEO, WEC and Village leaders that the MkV1 FS team are returning. Mobilisation will not involve any formal meetings as this is a continuation of work carried out previously. The mobilisation officer will also organise accommodation for the teams in the first community. For all subsequent communities the teams will ensure that at least one team member visits the next community to meet with the ward and village leaders and organise accommodation. The teams can use previously collected telephone contact details for local leaders to help them in their arrangements.
The mobilisation officer with the assistance of MkV1 FS senior staff will then start mobilisation at the major migration points. One or two MkV1 FS senior staff will visit all the districts where the mop-up will be done to explain to the DAS, DED, DEO and DMO the rationale of doing Mop-up. If that District wasn't among the four MkV1 FS was done explain to them that that is one of the districts with migration points where the field staff will be visiting selected villages, centres and/or towns to get YP. For the new Ward the staff will give a brief introduction in addition to the letter of introduction to the WEO. The senior staff in the team will visit the village leaders and explain the aim of the mop-up and the time expected to stay in the village. For the new village explanations about MkV1FS will be given

Phase 1 of Mop-up
Three mop-up teams will revisit each of the 20 trial communities to try to find eligible females and gather more moved away forms and/or improve the quality of information on the existing moved away forms.
When a mop-up team reaches the community they will set up a survey centre in the main village in that community and organise themselves to complete the following tasks: 1. Revisit all households which were not interviewed during the census 2. Revisit all hholds with a female who was invited to the survey, did not actively refuse to attend, but did not actually attend. These should be revisited whether or not they had a Moved Away Form, but with highest priority being those who did not have a Moved Away Form, then those with an incomplete Moved Away Form, then those with a complete Moved Away Form. 3. Visit households where moved away form information for a female is incomplete and seek further information/ contact details for moved away female. 4. Visit all trial schools with Master list of eligible students and with the help of the teachers try to locate females who were not identified during the census/survey. 5. Visit any secondary school in that community to try to find additional eligible females.
If an eligible female is found the fieldworker will invite the female to the survey site or, preferably, accompany her to the survey site.

Phase 2 of Mop-up
Following phase 1 the moved away form information will be summarised and locations with high numbers (eg 50 +) of potentially eligible females will be selected for phase 2. The three mop-up teams will then go to these major migration points outside the trial communities.
When a mop-up team arrives in the major migration point they will set up a survey centre. Team members will, using the moved away form information, try to contact potentially eligible females. If an eligible female is found the fieldworker will invite the female to the survey site or, preferably, accompany her to the survey site.

MkV1FS Protocol
There will be three survey teams with 15 members each.

(ix) Survey site procedures
The procedures at the survey site during the mop-up will be similar to those used during main survey. However, most of the team will work as tracers during the first day of the survey leaving only the 'core survey team' at the survey site. On subsequent days, depending on workload, the 'survey/ tracing team' will either work at the survey site or work as tracers. The best tracers and drivers will spend all their time tracing. * The teams will prioritise the tracing of females but if they meet an eligible male then he will also be interviewed At the migration points it is estimated that the teams will target ~ 2000 females over a 10 day period. Each team will trace ~ 70 females per day and will expect to interview ~ 30 females/ day.

Timetable and Logisitcs
Each team will have 2 landcruisers to transport them from community to community and to assist with tracing (6 vehicles in total). Sample collection and supervision will be done with another borrowed/hired vehicle or using the existing team vehicles.

Anticipated challenges
The registration interviewers will have to take care to check that a previously interviewed eligible YP is not interviewed again.
Poor documentation for first communities visited eg some households not on household head list.
Multiple copies of census ID number making merging with survey database difficult.
Logistics -especially sample collection

Advantages of mop-up
The mop-up will take place during the school holidays (except for Form 2 students who are preparing for exams) and this may mean that we find more eligible people in their home villages.
Some young people leave the villages during the farming season and may have now returned to their home village.
Young people who were afraid to participate in the survey/ to be identified may be willing to participate now as the community understand what MkV1 FS is doing and no longer fear?
Reports from the field suggest that in some communities eg Bukoli not all households were visited as households were very far from each other. The work of the census checker suggests that even where households are visited potentially eligible young people are missed.