A Randomized Controlled Trial Comparing the Effects of Counseling and Alarm Device on HAART Adherence and Virologic Outcomes

Michael Chung and colleagues show that intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure, whereas use of an alarm device had no effect.

 Ensure the quality of the laboratory facilities  Ensure the high quality of lab results  Supervise the laboratory and lab assistant  Separate, freeze, and process specimens at KNH or Coptic  Oversee and ensure that lab specimens at KNH or Coptic are properly separated and frozen.
 Give results of test in a timely and efficient manner

Arm A (Adherence Counseling)
Subjects randomized to Arm A will receive 3 sessions of educational adherence counseling. Two sessions will be completed before initiation of antiretroviral medications and one session will occur one month after. The first session will be an education session lasting for approximately 45 minutes and will cover topics including the cause of AIDS, the purpose of obtaining CD4 counts, the problems of drug side effects, and the dangers of viral resistance. A copy of the educational counseling protocol used in this first session is included in this chapter. The second session will assess the knowledge gained by the subject from the first session. If the subject fails in this assessment, either through poor knowledge, lack of demonstrated commitment, or community worker's judgment, then adherence session one will be repeated as many times as necessary. If the subject passes the second session then they may initiate antiretroviral medications that will be dispensed by the Study Pharmacist.
Upon randomization to Arm A, the study coordinator will insert the HAART Protocol sheet specific for Arms A and C in the subject's Hope medical folder. On the HAART Protocol sheet, adherence sessions will be marked as needing completion before the HAART Protocol is approved. After specimens are drawn in the laboratory, the Coordinator will send the subject to the Hope Center reception with a community worker who will schedule the subject for the adherence counseling sessions. After determining the dates from the receptionist, the community worker will log the counseling appointments in her calendar book, the subject's research file, and the research calendar book.
A research calendar book will be kept that tracks all subjects and shows which subjects are returning on each day so that the coordinator and community worker can determine if there are missed appointments. Subjects will be asked to stop by the research office on their way to clinic to log their clinic attendance in the large research calendar book.
The research calendar book will be overseen by the study coordinator and maintained by the Laboratory Assistant. Subjects will be asked and required to schedule clinic appointments at the Hope reception with a community worker present who can record these dates.
The community worker will track the subjects and their attendance in the counseling sessions. They will confirm that the subjects have attended all the counseling sessions prior to picking up antiretroviral medications from the study pharmacist. The study pharmacist will check the tracking form and ensure that adherence counseling sessions one and two and other study protocols have been completed prior to HAART initiation. At antiretroviral initiation, the community worker will check to ensure that the third adherence session is scheduled, and will note these appointments in the calendar books as above. At the Month 1 appointment with the pharmacist, the study pharmacist will check the tracking form if the subject has completed adherence session three. If this has not been done, the community workers and coordinator will be informed and this will be scheduled and completed before Month 2 pickup of antiretroviral medications from the study pharmacist.
If any adherence counseling appointments are missed, the community worker will note this through her calendar book and begin tracking the subject through phone calls and home visits with the knowledge and approval of the study coordinator.

Arm B (Alarm Device)
Subjects randomized to Arm B will receive an alarm device along and NO sessions of educational adherence counseling. Alarm devices will be programmed by the laboratory assistant to signal twice a day at a time most convenient to the subject. These pocket alarms devices will be carried at all times by the subjects and can be viewed as a pocket watch. Six months after initiating therapy and carrying the alarm device, the device will be brought back to the laboratory assistant who will disarm the alarm but continue to allow the subjects to carry the alarm as a pocket watch.
Upon randomization to Arm B, the study coordinator will insert the HAART Protocol sheet specific to Arms B and D in the subject's Hope medical folder. On the HAART Protocol sheet, NO adherence counseling sessions will be scheduled and adherence counseling will not be necessary for HAART Protocol approval and completion. After specimens are drawn in the laboratory, the coordinator will send the subject to the Hope Center reception with a community worker who will schedule the subject for the HAART Protocol. The community worker will ensure that the adherence counseling sessions will NOT be performed for any of these subjects in Arm B.
Community workers will ensure that the clinic receptionist only books subjects for Social Work and Nutritionist visits. After determining the dates for these visits from the receptionist, the community worker will log the counseling appointments in her calendar book, the subject's research file, and the research calendar book.
A research calendar book will be kept that tracks all subjects and shows which subjects are returning on each day so that the coordinator and community worker can determine if there are missed appointments. Subjects will be asked to stop by the research office on their way to clinic to log their clinic attendance in the large research calendar book. The research calendar book will be overseen by the study coordinator and maintained by the laboratory assistant. Subjects will be asked and required to schedule clinic appointments at the Hope reception with a community worker present who can record these dates.
At antiretroviral initiation, the study pharmacist will check the tracking form and ensure that the subject receives an alarm device from the laboratory assistant before receiving medications. Once the subject has obtained the programmed device from the laboratory assistant, the pharmacist will dispense HAART and follow the subject monthly. Any difficulties regarding the alarm device will be handled by the laboratory assistant. Lost or stolen alarm devices should be reported to the study investigators immediately.
At the Month 6 visit at the pharmacy for medication pick-up, the study pharmacist will check the tracking form and determine that the alarm device is to be returned to the laboratory assistant to be deactivated. At this visit, the alarm function of the device will be turned off. Thereafter, if requested, the device can be returned to the subject for use as a pocket watch. The study register/calendar will be checked regularly by the community workers, pharmacist, laboratory assistant, and coordinator to ensure that these devices are returned or switched off 6 -7 months after HAART initiation.

Arm C (Adherence Counseling and Alarm Device)
Subjects randomized to Arm C will receive 3 sessions of educational adherence counseling and an alarm device. Two adherence sessions will be completed before initiation of antiretroviral medications and one session will occur one month after. The first session will be an education session lasting for approximately 45 minutes and will cover topics including the cause of AIDS, the purpose of obtaining CD4 counts, the problems of drug side effects, and the dangers of viral resistance. A copy of the educational counseling protocol used in this first session is included in this chapter. The second session will assess the knowledge gained by the subject from the first session. If the subject fails in this assessment, either through poor knowledge, lack of demonstrated commitment, or community worker's judgment, then adherence session one will be repeated as many times as necessary. If the subject passes the second session then they may initiate antiretroviral medications that will be dispensed by the Study Pharmacist.
Alarm devices will also be given to subjects and be programmed by the laboratory assistant to signal twice a day at a time most convenient to the subject. These pocket alarms devices will be carried at all times by the subjects and can be viewed as a pocket watch. Six months after initiating therapy and carrying the alarm device, the device will be brought back to the laboratory assistant who will disarm the alarm but continue to allow the subjects to carry the alarm as a pocket watch as they desire.
Upon randomization to Arm C, the study coordinator will insert the HAART Protocol sheet specific for Arms A and C in the subject's Hope medical folder. On the HAART Protocol sheet, adherence sessions will be marked as needing completion before the HAART Protocol is approved. After specimens are drawn in the laboratory, the Coordinator will send the subject to the Hope Center reception with a community worker who will schedule the subject for the adherence counseling sessions. After determining the dates from the receptionist, the community worker will log the counseling appointments in her calendar book, the subject's research file, and the research calendar book.
A research calendar book will be kept that tracks all subjects and shows which subjects are returning on each day so that the coordinator and community worker can determine if there are missed appointments. Subjects will be asked to stop by the research office on their way to clinic to log their clinic attendance in the large research calendar book. The research calendar book will be overseen by the study coordinator and maintained by the Laboratory Assistant. Subjects will be asked and required to schedule clinic appointments at the Hope reception with a community worker present who can record these dates.
The community worker will track the subjects and their attendance in the counseling sessions. They will confirm that the subjects have attended all the counseling sessions prior to picking up antiretroviral medications from the study pharmacist. The study pharmacist will check the tracking form and ensure that the alarm device, adherence counseling sessions one and two and other study protocols have been completed prior to HAART initiation. The alarm device will be handed out by the laboratory assistance. At antiretroviral initiation, the community worker will also check to ensure that the third adherence session is scheduled, and will note these appointments in the calendar books as above. At the Month 1 appointment with the pharmacist, the study pharmacist will check the tracking form if the subject has completed adherence session three. If this has not been done, the community workers and coordinator will be informed and this will be scheduled and completed before Month 2 pickup of antiretroviral medications from the study pharmacist.
If any adherence counseling appointments are missed, the community worker will note this through her calendar book and begin tracking the subject through phone calls and home visits with the knowledge and approval of the study coordinator. Any difficulties regarding the alarm device will be handled by the laboratory assistant. Lost or stolen alarm devices should be reported to the study investigators immediately.
At the Month 6 visit at the pharmacy for medication pick-up, the study pharmacist will check the tracking form and determine that the alarm device is to be returned to the laboratory assistant to be deactivated. At this visit, the alarm function of the device will be turned off. Thereafter, if requested, the device can be returned to the subject for use as a pocket watch. The study register/calendar will be checked regularly by the community workers, pharmacist, laboratory assistant, and coordinator to ensure that these devices are returned or switched off 6 -7 months after HAART initiation.

Arm D (Control)
Subjects randomized to Arm D will receive NO alarm device and NO sessions of educational adherence counseling. Upon randomization to Arm B, the study coordinator will insert the HAART Protocol sheet specific to Arms B and D in the subject's Hope medical folder. On the HAART Protocol sheet, NO adherence counseling sessions will be scheduled and adherence counseling will not be necessary for HAART Protocol approval and completion. After specimens are drawn in the laboratory, the coordinator will send the subject to the Hope Center reception with a community worker who will schedule the subject for the HAART Protocol. The community worker will ensure that the adherence counseling sessions will NOT be performed for any of these subjects in Arm B.
Community workers will ensure that the clinic receptionist only books subjects for Social Work and Nutritionist visits. After determining the dates for these visits from the receptionist, the community worker will log the counseling appointments in her calendar book, the subject's research file, and the research calendar book.
A research calendar book will be kept that tracks all subjects and shows which subjects are returning on each day so that the coordinator and community worker can determine if there are missed appointments. Subjects will be asked to stop by the research office on their way to clinic to log their clinic attendance in the large research calendar book. The research calendar book will be overseen by the study coordinator and maintained by the laboratory assistant. Subjects will be asked and required to schedule clinic appointments at the Hope reception with a community worker present who can record these dates.

Collection and transportation of Samples from RCT Adherence Intervention Clinic
 Lab Assistant will collect one tube of blood sample in a well-labeled 10 ml tube (purple top)  After collection of sample details will be recorded in clinic lab book.

Receiving Samples
 All details of sample delivered will be recorded in a laboratory research book -Specimen ID, Date, number of tubes, and blood volume

Preparation of Workbench at laboratory
 Wear an appropriate size pair of latex gloves.
 Clean your work surface with 70% alcohol or > 10% Jik diluted in tap water.
 Prepare work area in the hood; bleach bucket, racks, tips, gauze, ect.

Plasma Separation
 Spin blood at 1,800 rpm for 10 minutes at room temperature and set brake to low (make sure to put a cap on the bucket during the spin). Record all spins in centrifuge logbook. Medical and clinical officers at the Hope Center will help identify patients that meet eligibility criteria for this study. Once a medical professional has identified these patients they will assess if the patient is willing to learn more about the research study. If the patient is not interested in the study, the patient will continue receiving services at Hope Center. Each medical officer will address interest by giving a brief statement about the study. For more information on talking points for recruitment please review chapter seven.
If the patient is interested in learning more about the research study, the clinical officer will phone the research facility and speak with the study coordinator. The community health worker will carry the patient's Hope Center file and guide the patient to research facility. The participant will be introduced to the study coordinator who will explain more about the study and enroll the patient if they are interested in participating.

Overview of Study Recruitment
The study nurse will introduce the purpose of the research study. In addition she will review the risks and benefits of being involved in participating in the research study.
She will also review and confirm that the patient is eligible for the study.
If the subject continues to be interested in participating in the research study and meets eligibility criteria, the patient can be enrolled into the Adherence Study.

 Informed Consent
The subject will be required to understand and sign this document. The study coordinator will give the patient the consent in Kiswahili or English to read. If the participant has any questions the study coordinator shall answer all questions prior to enrollment. If the participant agrees verbally and signs the written consent, the patient will be enrolled into the research study.

 Randomization
The study coordinator will start by assigning the subject a research ID number. She will keep track of all research ID numbers in her log book. After assigning the subject with an ID number, she will select the study envelop corresponding to that research ID number which will randomly place the subject in one of four arms.
 Transferring of Information -Creating a new Hope File and research file The study coordinator will then move all the information from the Hope file to a new Hope file (which will be a different color from previous Hope File). She will also place a HAART protocol checklist which will assign the appropriate interventions for the subject depending on which arm of the study the participant has been placed. In addition the study coordinator will exchange the appointment card given at the Hope Center with a different color appointment card. She will write the research ID number in the right hand corner of the appointment card and will write the arm the subject has been placed in left-hand corner.
The randomization envelope will then be placed in a new Adherence Study Research file that will be used to keep track of all research information. The file will be selected based on which Arm the patient was selected for. The study coordinator will place the research ID number on the front of the file. In addition place the signed consent into the research file. The study coordinator will then administer 2 questionnaires: Address and Intake and Enrollment.

 Laboratory Specimen Collection/Knowledge Assessment
After the subject has completed these questionnaires, the participant will be taken to the laboratory. Here the lab assistant will introduce himself and administer the Knowledge Assessment questionnaire. He will place the questionnaire within the research file which will kept in the laboratory. After this the lab assistant will begin procedures for specimen collection.

 Appointment Schedule
After specimen collection the new Hope Center file, appointment card, and the subject will be assigned a community health worker. This CHW will accompany the subject to the Hope Center reception to help schedule visits according to the patient's HAART Protocol checklist. The appointments that will be booked for each group are below: Arm A and C: Book 4 appointments for the HAART protocol The CHW will record the dates for these appointments on the subject's appointment card and their own study diary. After this they return back to the study laboratory to record the appointments in the Adherence study research file and the study schedule binder.

 Home Assessment
If there is time, the CHW will accompany the patient home to complete the Home Assessment questionnaire. If this is not possible the CHW will schedule a home visit with the patient at the next appointment. This assessment must be completed prior to the start of antiretroviral medication. The assessment will include the collection of GPS coordinates of the subject's home. The GPS device will be given by to the CHW by the laboratory assistant. Transportation funding will be given by the Study coordinator; money will be given for one-way transportation of the subject and twoway trip for the CHW. Petty cash will be kept by the study coordinator and a record book will be used to keep track of all funding.

Appointments Prior to Initiating HAART
Subjects will be required to schedule appointments at the Hope Center and complete the HAART protocol according which group (arm) they have been placed in.
All appointments will be made with the help of the community health workers. The Hope Center reception will be informed that all appointments for research subjects must be accompanied by a CHW.
Subjects should present themselves to the research study clinic prior to there Hope Center appointments. They will check-in with the CHWs or study coordinator who will sign the study calendar that the patient has arrived for their appointment.
For every appointment the subject is advised to stop by the study office to checkin prior to Hope visit. After Hope visit, the subject will inform the study office to help make appointment with community health worker.
After each subject has finished the HAART protocol, according to the arm they were placed in, they will accompany the community worker to help book an appointment to see the medical/clinical officer. The medical professional, will make the decision to start antiretroviral medications.
If the subject is approved to start antiretroviral medications, his or her file must be brought to senior Hope management to certify completion of the HAART protocol. After certification, the participant will accompany the community health worker to the reception to book appointment for medical visits after two weeks and adherence 3 in six weeks (if the participant is assigned to adherence counseling). Then the subject will be referred to pick-up medications at the study pharmacy.

Medical Appointments and Follow-up
After starting medications, the patient will visit the medical officer after two weeks to review medication side effects. If subject is tolerating medications, the community health worker will help the subject book an appointment to see the clinical officer in 2-3 months for further follow-up.
All medical concerns will be within the purview of the Hope Center for Infectious Disease. The subject will be seen every 2-3 months for medical follow-up throughout the course of the study. Every six months a CD4 count and viral load will be conducted.
This information will be gathered via the medical follow-up and lab forms scanned into the Hope Center database. All medical visits will be recorded and followed by the community health workers.
If the subject becomes ill, or needs medical attention, they can be seen at the Hope Center at any point during the study. The study coordinator will request that the subject stop by before to inform the study that he/she is in need of medical attention.
These appointments will be recorded as Medical PRN visits in the study calendar.

Pharmacy Appointments and Follow-up
The study pharmacy technologist will review the patient's research file to verify completion of adherence interventions. If the patient is to receive the alarm device, she will refer the patient to see the lab assistant or the study nurse to receive the study device.
After which she will give the patient counseling on the use and side-effects of antiretroviral medications. She will book the participant to see her in two weeks to increase the medications. She will record the scheduled visits in the study file and pharmacy calendar file. In addition this appointment will be kept in the computer pharmacy database.
When the subject returns, the pharmacy technologist will perform a pill count and a follow-up questionnaire form. After which the pharmacist will book an appointment to see the subject every 4 weeks.
At the end of month one, the pharmacist will verify that the patient has completed adherence #3 (Arm A and Arm C), is using the alarm device (Arm B and Arm C), or using neither intervention (Arm D). At the end of the 6 month visit the pharmacist will make sure that the alarm device will be stopped and retrieved by the study pharmacist (for arms B and D). In addition the pharmacy technologist will ensure the completions of appropriate knowledge assessment questionnaires and collection of lab specimens at month 6, month 12, month 18. For more information on the pharmacy please review chapter six.

General Counseling
At any time the subject can be recommended to receive more counseling in regards to social issues; this includes problems with disclosure, stigma, or economic.
However the role of the counselor during these sessions will not include the adherence education and counseling which will be limited for certain arms of the study.

Loss to Follow-up
If the subject misses any of the scheduled and recorded appointments, the subject will be identified and recorded by the study coordinator. At each weekly meeting subjects who have missed appointments will be discussed. If the patient is unable to be reached, a community health worker will be recruited find the subject and file a Home Tracing form.
If the participant is not found, the subject will be discussed and a Lost to Followup form will be filed and placed in the subject's research file. If the subject is found to have passed away, the study coordinator and principal investigator should be notified. In addition a Mortality form will file by the study coordinator. If the patient is found, he or she will be asked a few questions and will be encouraged to return to clinic. If the subject refuses to return, the community health worker will exit the patient from the study. If the patient is found to be hospitalized, the study coordinator and principal investigator should be notified immediately, and the reason for hospitalization should be recorded.

Data Management Databases
The study databases are recorded in Microsoft Access, SPSS, GIS software programs or a written notebook and include: . GIS Database --GPS locations of subjects will be collected by community health workers using a Garmin GPS device. This data will be stored and downloaded to computers at Kenyatta National Hospital. The software used to store and analyze this data is ArcView 3.2.

RCT Adherence Intervention Research Clinic at Coptic Hospital
The on-site facilities available for the research study include two desktop computers. One computer is devoted to programming alarm devices, while the other is designated to collect and track pharmacy information. Each computer is outfitted with a CD-burner. None of the computers have internet access.

Kenyatta National Hospital
The RCT Adherence Intervention study has a data office in the department of Obstetrics and Gynecology at the University of Nairobi, Kenyatta National Hospital.
There are five desktop computers, one laser printer, one scanner, one zip drive, and two CD-burners. All computers except the data computer have internet access. All computers have antivirus software which is kept up to date by the data manager.
Questionnaires are entered into the computer using Cardiff Teleform software and a Fujitsu scanner. GIS information is downloaded to the computer using ArcView 3.2 software. All computers have SPSS installed.

Hope Center at Coptic Hospital
The RCT Adherence Intervention study will bring medical data collected from the Coptic Hope Center database. At this facility there are two desktop computers, one scanner, and two CD-burners. None of these computers have internet access. All computers have SPSS installed.

Entry
Most data is collected on study subjects using questionnaires. Each subject has a folder in which all questionnaires are stored. These folders are stored in a locked cabinet in the study clinic at Coptic Hospital research facility. Newly filled-out questionnaires are brought to the office from the clinic daily. Questionnaires are scanned into the computer database the same afternoon, and folders are returned to the clinic the following morning. Scanned data is verified by Teleform software and later cross-checked against the paper questionnaire on the same day by the data clerk after it is exported into SPSS.

Quality
1. The data clerk maintains a data logbook where all the data entry queries or errors encountered during data entry are recorded. Data entry queries or errors are then discussed with the study staff at least once a week. Discussions are held with both study staff and data clerk together at the study clinic and corrections are made to the database by the data clerk upon returning to the data office. The data manager ensures that all errors are attended to on a regular basis.
2. The data manager ensures that all the data is clean at all times. Questionnaire data is checked for entry accuracy at the time of scanning. In addition, data checking is done on the databases every week and the data manager takes responsibility for organizing the data checking process. If errors are found, the folders are brought from clinic and checked for inconsistencies. A summary report on the data quality and data entry accuracy is then produced by the data manager and distributed to the project investigators.
3. Data checking is done using the following methods:

 Ranges and Validity rules
A range of acceptable values has been set for all the appropriate variables.
Any values that fall outside this range cannot be accepted by the database.
Validity rules are also set where certain variables can only be entered if they comply with a particular rule. For example, the database does not allow outside limit or blank entries for the patient identification numbers and all unreal dates are rejected. The data manager works with the data entry clerks to identify any inconsistent data on a weekly basis. Inconsistency checks are done when the files are in SPSS. The manager then consults with study clinicians to resolve the inconsistencies.

 Line listings
The main objectives of line listings include: 1. identifying any errors made during data entry 2. estimating the accuracy rate of the data entry clerk, monitor and asses his/her data entry performance The data manager produces line listings of all the enrollment and follow-up files on a monthly basis. The data team members then check the line listings against the hard copy questionnaires. Errors are highlighted on the line listings and the error rate approximated thereafter.
After the checking has been completed, the data manager lists all the corrections that need to be done in the patient charts on the data entry sheet, this helps the data entry clerk easily identify the corrections that need to be done.

 Missing values
The data entry clerk identifies any missing values during data entry. Where values are missing, the data entry clerk notes this down on the data entry sheet of the respective folder and in the data logbook. At least once a week, the study staff will review errors that are determined in this manner.

Hope Center Questionnaires
Entry Entry of questionnaires of study subjects at the Hope Center is similar to entry of questionnaires at the study facility. The only exception being that each research subject has a folder (designated in a different color from other Hope patients) which is kept in a locked cabinet at Coptic Hospital Hope Center. These questionnaires are scanned into the computer database within 24 hrs and folders are returned to the clinic after scanning.
Scanned data is verified by Teleform software and the data clerk keeps records of all errors made. The scanned data is exported to SPSS.

Exporting data to CD
Every Thursday, the data clerk from KNH will meet with the data manager at Coptic Hope Center. The data clerk will have a list of all Hope ID numbers for all research subjects. All the information collected about the research subject at the Hope Center in SPSS will be exported and copied to a CD which will be kept by the research data clerk. Each week new research participants' data will be added to questionnaire data from the previous research participants. The data clerk will review information and conduct quality checks on information on a weekly basis.

Entry
Information that is recorded in the pharmacy will be recorded using Microsoft Access. Data on pill counts and appointment schedule will be recorded directly into the database.

Exporting data to CD
Every Thursday, the data clerk from KNH will meet with the pharmacy technologist at Coptic research facility. All the information collected about the research subject will be exported and copied to a CD which will be kept by the research data clerk.
The data manager and data clerk will review information and conduct quality checks on information on a weekly basis.

Quality
The quality of data collected on research subjects at the Hope Center clinic and the pharmacy database will be checked by the data clerk and data manager creating and using SPSS programs to identify errors. Three types of errors identified:

 Missing values
The data clerk will identify any missing values of the information collected from the exported SPSS files. Where values are missing the data clerk will note these in a log book to review with the Hope Center data manager or pharmacy technologist twice a week.

 Range, Validity, and Inconsistency rules
A range of acceptable values will be set for all the appropriate variables. In addition the data manager will create validity rules for certain variables which will marked as errors if they do not comply with a particular rule. For example, the quality checking program will identify all variables outside the limit or blank entries for the patient identification numbers and all unreal dates are rejected. Violations of these rules will be marked by the data clerk and recorded in the data error log. These will be reviewed with the data manager and Coptic data manager on a weekly basis. Again the data manager will create an SPSS quality checking program which will identify problems with data. For example cross-checking variables such as the subject being male and pregnant or a greater than 50 kg increase in weight in less than a month. These will be recorded by the data clerk and discussed at weekly data meetings.

Safety
All databases are backed up every Friday by saving the most current files on two CD disks.

Security
 All computers are password-protected, preventing access by any unauthorized persons.
 Data is backed up on a weekly basis by the both the data clerks and the data manager. Data is saved on two CD disks. One set remains with the data manager and the other is kept with a study investigator at an off-site location.

Storage
All patient records are filed according to numerical order of the patients' identification.
Folders are kept in a locked storage cabinet at the study clinic for reference by research personnel. Once the subject completes the study or is lost to follow-up, her records are brought to the KNH office for storage. inconsistencies. This will be done by the lab technologist on a daily basis and checked once a month by the data clerk.

Data Schedule
 Computer update -this requires defragmenting the hard drive, updating the virus library, and scanning the hard drive for viruses on all computers

b) Tuesday
 Questionnaire error checking -The data clerk uses the Questionnaire Error Checking Book to discuss any errors with study staff at the research facility and will correct all error upon returning to KNH.
 Exporting Data from Hope Center and Pharmacy databases -The data clerk will burn a CD of information collected by Hope Center on research subjects. In addition the data clerk will burn information collected on the pharmacy database.

c) Wednesday
 Data meeting with Coptic Data Manager -The data manager and data clerk at KNH will meet with the Hope Center Data Manager to discuss any errors within the data collected from the Hope Center questionnaires.
Errors are corrected at this time.

d) Thursday
 Questionnaire error checking -The data clerk uses the Questionnaire Error Checking Book to discuss any errors with study staff at the research facility and will correct all error upon returning to KNH.
 GPS Downloading -The data clerk will bring the GPS devices from the community health workers and download the data points from previous e) Friday  Backup data -Data is backed up on two CDs. One CD and one zip disk remain with the data manager while the other set is given to a study investigator who takes it to an off-site location.
 Summary weekly-a summary and analysis of the data is generated weekly by the data manager for the Administrative meeting. This summary should include:

Pharmacy Introduction
The study pharmacy is one of the most important points of contact between the research subject and the study. The study pharmacist will be seeing subjects most frequently among study staff since subjects will be picking up their medications at the pharmacy on a monthly basis throughout the 1 ½ year duration of the study. The pharmacist will not only be responsible for educating subjects newly initiated on HAART but will be tracking a subject's ability to remain adherent to antiretroviral medications through counting unused pills monthly. Because a subject's ongoing relationship with the study will develop through the pharmacy, the pharmacist will ensure that study time-points such as specimen collection and knowledge assessment every 6 months are also met.

Coptic Hope pharmacy
The study pharmacy will dispense drugs to patients on behalf of the Coptic Hope pharmacy. The reason to dispense drugs through the study pharmacy is to ensure proper follow-up of study subjects and to conduct pill-counts that are not usually performed in the Hope pharmacy. The pharmacist should work closely with Dr. Mouheb at the Hope pharmacy to transfer antiretroviral medications and other drugs to the locked cabinet in the study pharmacy. An accurate inventory of drugs transferred between the Hope pharmacy and the study pharmacy must be maintained by the pharmacist. As per Dr. Mouheb, drug stocks at the study pharmacy can be replenished on a monthly basis or on the basis of need.
All drugs acquired through the Hope pharmacy to be dispensed at the study pharmacy will be free of cost since they are either donated by the Government of Kenya or PEPFAR.

Pharmacy database
Inventory of drugs as well as monthly pill counts and patient drug history are to be recorded on the computer MS Access pharmacy database developed by Management Health Sciences (MHS) and customized by the data office. Every time a subject comes to pick up their medications, the pharmacist should login into this database and fill it out accordingly. This is the same database that the Coptic Hope pharmacy uses with few modifications. These databases will be merged at the Hope data offices for record-keeping therefore every effort should be made to make the databases compatible in terms of drug accounting. The study pharmacy database contains an extra page of reporting pill counts that should be filled out at each monthly patient visit. This page of information is not included in the Hope pharmacy database. Any changes to the database should be coordinated with Dr. Mouheb at the Hope pharmacy and Charles in the data office.

HAART Initiation
When a patient is to initiate HAART for the first time, the pharmacist should check the Tracking form see that all steps have been conducted and checked prior to administration of drugs. If any of the steps have not been taken (for example, Arm A subjects have not undergone adherence counseling), then the pharmacist should not administer the drug but re-book the subject to complete the necessary steps. Please review chapter 4 to learn what steps subjects in various arms must undergo before initiation of HAART.
Most, if not all, patients will start a nevirapine-containing regimen. This means that patients will start nevirapine at half the regular dose and increase their dose 2 weeks after drug initiation. Therefore, patients should be requested to return after 2 weeks to increase the regimen to full dose.
At the first visit and each visit thereafter, the pharmacist should write down the next appointment for the subject in the "Pharmacy Followup tracking form" and fill in the "Followup" questionnaire. This information should be kept in the patient's file and regularly scanned into a computer database by the Data clerk.

Follow-Up
Subjects should follow-up with the pharmacists on a monthly basis to pick up their refills of antiretroviral medications. Patients are required to return monthly and not longer.
Under no circumstances are patients to be given prescription refills greater than one month in duration. Monthly visits to the pharmacy are necessary in order to perform pills counts which are the primary outcome of measurement in this study and therefore a requirement for participation.
The visits are also an important time to track the completion of Knowledge Assessment forms and Specimen Collection and Adherence #3. Knowledge assessment forms are administered by the laboratory assistant. The first assessment is done at enrollment. The next knowledge assessment is performed one month after initiating HAART. Thereafter, it is administered every 6 months from HAART initiation. It is the responsibility of the pharmacist to ensure that knowledge assessments are performed at the specified dates due, by tracking the subjects on the Pharmacy Follow-up Tracking form.
Antiretroviral drugs are not to be administered until these knowledge assessments are performed.
At the same time as knowledge assessments at months 6, 12, and 18 after HAART initiation, blood specimens are to be collected from the subject. One vial of blood will be collected by the laboratory assistant immediately after or before the knowledge assessment form is filled out. Again, antiretroviral medications are not to be dispensed until specimens are collected on the specified dates after HAART initiation.
Those subjects randomized to receive Adherence counseling are in Arms A and C.
The pharmacist should track these subjects closely to ensure that Adherence counseling #3 is conducted 6 weeks after initiating HAART. Therefore, the first month after starting the full-dose nevirapine regimen, the pharmacist should check that Adherence #3 has been performed before dispensing any medications.

Talking Points for Hope Center Staff
Dr. Michael Chung will be conducting a research study at the Hope Center. This study will examine how to help patients adhere to their medications by comparing different interventions. 400 adult patients will be enrolled in the study. They will be randomly assigned to 1 of 4 groups. Each group will contain 100 people. These patients will be followed over 18 months and will receive their medical care at the Hope Center.
Participation in the research study is entirely voluntary and will not affect medical care at Hope in any way. Patients who decide not to participate will continue to be treated at Hope. Patients who do participate will be treated like any other patient except for the aspect of adherence counseling and promotion. This aspect of care will be determined by the research study for the 1 ½ years these patients are enrolled in this study. Enrolled study patients will also pick up their antiretroviral prescriptions from the Study Pharmacist and not the Hope Center pharmacist.
Patients will be invited to enroll in the study if they are > 18 years old, are eligible to start antiretroviral medications, will allow home visits, and plan to live in Nairobi for at least 2 years.
Clinical officers who identify HAART treatment naïve adult patients who are eligible for treatment by CD4 count or WHO clinical staging will refer these patients to the Study Nurse before sending them to the HAART Protocol.
The Study Nurse will explain the study to the patient and invite them to join. If an individual does not want to participate the Study Nurse will continue them on the HAART protocol and they will remain at the Hope Center to receive antiretroviral treatment. If patients decide to join, then the Study Nurse will modify the adherence counseling that they will receive. Subjects will be assigned to one of the following groups: 1. a group that will receive 3 education counseling sessions from a counselor about how to take anti-HIV medications correctly; 2. a group that will carry an electronic alarm device for six months to help remember when to take anti-HIV medications; 3. a group that will receive both education counseling and carry the alarm device for six months; 4. and a group that will receive neither intervention All subjects will receive counseling from the Study Pharmacist. They will continue to receive medical care and free antiretroviral treatment at the Hope Center, the same as any other patient at the Hope Center. They will also see the nutritionist and the social worker. However, they will not be part of the standard Hope adherence counseling sessions.
The Study Nurse will be available at morning meeting everyday to discuss any questions you might have. She will also speak to clinical officers to discuss potential patients who might be referred to the study.
If you have any questions or concerns the Study Nurse can't answer, please contact Dr. Michael Chung at 675-1136.

Talking Points for Recruitment
You are being invited to participate in a research study at the Hope Center. The study is being conducted by Dr. Michael Chung and other doctors from the University of Washington in America and the University of Nairobi. The Hope Center is where the study will take place although the Coptic Hospital is not directly involved in the study.
This study examines how to help patients take their anti-HIV medications correctly.
You do not have to join the study. Whether or not you join the study will not impact your care at the Hope Center in any way. If you are eligible, you will still receive free antiretroviral treatment and care from the Hope Center. If you do participate, you will continue to receive free antiretroviral treatment and care at Hope now and after the study is done. The main difference between the joining the study and not joining is the type of counseling and support you will receive to know when and how to take your medications correctly. 400 adult patients will be enrolled in the study and will be assigned to 1 of 4 groups. Each group will contain 100 people. If you decide to join the study, you will be put in one of these groups and followed for 1 ½ years in the study.
The study will also see where your home is located from clinic and the neighborhood where you live. We will do this to see if these things influence whether you take your medications correctly, to provide social support, and to trace you if you become lost to the study. We will also draw blood from you 4 times over 18 months in order to see how much HIV is in your blood and whether the adherence interventions are working for you.
You are referred to us because the clinical officer has determined that you need to start anti-HIV medications to treat your HIV disease.
 Do you plan to start anti-HIV medications as your doctor suggests?
 Are you over 18 years of age?
 Have you ever taken anti-HIV medications before?
If you are interested in the study, I will explain more about it from the informed consent form which I will give or read to you. If you still want to be in the study after reading or being read the informed consent, you can sign the form and we can enroll you in the study.

INTRODUCTION
At the conclusion of the first session of Adherence Counseling, patients will understand:

ADHERENCE
How should you take ARVs?
 You must take the correct dosage. If you take less than the dose prescribed the treatment will not be effective and will result in resistance and treatment failure.
Therefore, do NOT share ARVs with anyone.
 You must take ARVs at the right time of day. Most ARVs are taken twice a day.
This means that you would take your medicines every 12 hours, e.g. 7:00AM and  It is essential to take ARVs exactly as prescribed and not miss doses.
 ARVs will only work when the amount of drug circulating in the body is kept at a certain level. For this to happen, you must take ARVs exactly as prescribed.
 Some other medications interact with ARVs and make them ineffective. Be sure to tell your doctor and pharmacist the names of all the medications (including traditional/herbal medicines) that you are taking as well as any new medications.
How can you make sure you take the ARVs as prescribed?
 Ask a friend, partner, or family member to remind you to take the medications  Set a scheduled time in the day to take the ARVs  Put up notes in the home or at work to remind you to take the medications  Associate your doses with an event that occurs at the same time everyday. For example, when you eat breakfast and dinner.
 You can set dose reminders with an alarm clock, an alarm device, a watch, or cell phone.
 Please tell me some ways you plan to help yourself remember to take ARVs.

DECISIONS ABOUT STARTING ARVs
What do you need to think about before starting ARVs?
 Deciding whether to start ARV treatment is your decision  You should wait to begin therapy until you feel ready  Take enough time to think the decision through and get as much information about ARVs as you need  Feel free to ask many questions about ARVs to the doctor, pharmacist, or counselor  Starting ARVs is never an emergency but should be done only after one has made a commitment to taking lifelong therapy Ask yourself certain questions to determine if you are ready to start ARV therapy:  Can I come every month to the HIV clinic/doctor's office for follow-up and medicine refills?
 Will I commit myself to tolerating the side effects for the sake of a better quality of life in the future?
 Do I have adequate support (e.g., a family member or friend) who can help me adhere to the treatment?
 Can I meet the financial obligations for adherence to ARVs?
 Can I take the medications everyday according to the prescribed schedule?

GUIDELINES FOR PHARMACIST ARMS A, B,C, and D: CONTROL
Basic caution on the possible adverse effects of antiretrovirals and the importance of maintaining therapy will be given by the pharmacist at the time of drug administration.

ADHERENCE
How should you take ARVs?
 You must take the correct dosage. If you take less than the dose prescribed the drugs may not work. Therefore, do NOT share ARVs with anyone.
 You must take ARVs at the right time of day. Most ARVs are taken twice a day.  Assess client's knowledge of side effects related to his/her ARV regimen and the appropriate response to deal with side effects Do you know how long you should normally take ARV?
Assess whether client knows that ARV is life-long treatment.
Do you know what happens if you don't take your ARV consistently?
Assess whether client understand the problem of resistance given ARV interruptions Do you know the purpose of CD4 counts?
Assess whether client knows that CD4 count is a laboratory indicator for monitoring the effect of ARV. Are you still interested in taking ARV?
Assess whether client continues to be motivated to begin treatment.
If yes, what are your expectations from ARV?
Assess whether client has realistic expectations, e.g., prolonging life, keeping them well enough from their family, etc. Assess for false expectations, e.g., a cure for HIV, etc. Assess for factors that help determine capability for follow up Assess whether client can attend HIV clinic for follow up medical and counseling care.
Ask the client whether s/he feels ready for long term treatment; if s/he can come to HIV clinic for regular follow up.
Assess commitment for long-term treatment.
Ask the client whether s/he has a relative/friend whom he can rely on to support him take ARV.
Assess availability of support at home.

Ask patient if s/he has barriers to adherence
Assess barriers to adherence and progress made On a scale of 1 to 10 (10 being most ready, 1 being least), please rate the client's ability to adhere to medications.

Least likely
Likely Most likely 1 2 3 4 5 6 7 8 9 10 Does the patient need to move forward with the protocol or to repeat Adherence Counseling #1?

ADHERENCE COUNSELING #3
To be repeated one month after starting ARVs Assess client's knowledge of side effects related to his/her ARV regimen and the appropriate response to deal with side effects Do you know how long you should normally take ARV?
Assess whether client knows that ARV is life-long treatment.
Do you know what happens if you don't take your ARV consistently?
Assess whether client understand the problem of resistance given ARV interruptions Do you know the purpose of CD4 counts?
Assess whether client knows that CD4 count is a laboratory indicator for monitoring the effect of ARV. How are you taking your ARVs?
Assess whether client continues to be motivated to begin treatment. If yes, what are your expectations from ARV?
Assess whether client has realistic expectations, e.g., prolonging life, keeping them well enough from their family, etc. Assess for false expectations, e.g., a cure for HIV, etc. Assess for factors that help determine capability for follow up Assess whether client can attend HIV clinic for follow up medical and counseling care. Ask the client whether s/he feels ready for long term treatment; if s/he can come to HIV clinic for regular follow up.
Assess commitment for long-term treatment. What will help? Ask the client whether s/he has a relative/friend whom he can rely on to support him take ARV.
Assess availability of support at home. If none exists, did you think of other options?
Ask client whether s/he sees the need for continued prevention.
Assess review need for continued prevention e.g. condom use During the last 7 days how many ARV pills did the patient MISS taking? (tick one) On a scale of 1 to 10 (10 being most ready, 1 being least), please rate the client's ability to adhere to medications.

Least likely Likely
Most likely 1 2 3 4 5 6 7 8 9 10 Does the patient need to move forward with the protocol or to repeat Adherence Counseling #1?

Questionnaire Definitions General Information
In this section, basic instructions are provided on how to complete the questionnaires.
After reading the following section and you want further clarification please direct your questions to the data manager and principal investigator.

Delivering the Questionnaire Questions
Read the questions exactly as they are written in the questionnaires. Closely follow the instructions of each section when asking the questions.
After reading a question in a clear and comprehensible manner, wait quietly for a response. If the respondent does not answer in the reasonable time, he has probably 1) not heard the question; or 2) not understood the question; or 3) does not know the answer. If there is no answer, repeat the question. If there is still no reply, you must ask whether the question has been understood. If the answer is 'No', you may reword (rephrase) the question. If the difficulty lies in finding the right answer, you should help the respondent to consider his/her reply. Interact with the client as much as possible.

Recording responses
The response received from the respondent should be written on the questionnaire in blue or black biro pen. Responses written in pencil can easily become smudged and difficult for the scanner to read and interpret. Also do NOT use other funny pens/ biro pens or fountain pens other than the above stated pens.
Responses should be written clearly in upper-case letters.

Correcting mistakes
If a mistake is made in the recording of a response, do not erase the response using white out. Please circle the wrong answer and strike through the wrong answer once. After this initial and date the mistake on the form. Then check (tick) the right answer or write the correct response next to the question. Example:

Write clearly
Always write very legibly in capital (BLOCK) letters. This instruction is particularly important for the Address and Intake, because the names and locations of the client are the most important connecting points with the patient. If the response is not legible, the data clerk nor the scanner will be able to work with the information.

FORM PLEASE CONSULT WITH THE DATA MANAGER.
AR 5/5/06

Enrollment Form
Study ID number This is the unique research identification number that is given by the study coordinator at the time the subject enters the research study.
Interviewer number This is a unique code given to all interviewers in the study staff. If you do not have an interviewer numbers please contact the data manager.

Date of the interview
Provide the current date that the interview is taking place. Information on dates should be recorded as day (dd), month (mm), year (yyyy).

Q1: Date of birth:
Ask for the date of birth when the client was born. For older individuals who may have trouble determining the month and day of birth complete as much of the information on the birth date as you are able to. If unknown, please complete the information as accurately as possible. For example if the subject knows the year, fill in the year that he or she was born. If the date of birth is not stated or unknown then code "01" for day, "01" for month and "9999" for year. Also include in a note on the side that the patient did not know the day, month or year of birth.

Q2: Age (year):
Ask how old the patient is in years. If this does not correspond to the date of birth, please re-state the question to the subject. Record the answer as the subject states it in the box, make a note on the side of the questionnaire that the response does not agree with date of birth.

Q3. Gender:
Ask the sex of the individual. Do not use the name of the individual to assume the sex of that individual. However, some caution in asking this is important not to offend the respondent.
Q4: How many years of school did you complete?
The question should be interpreted as years of school and not include years of school repeated.
Q5: Highest education level completed?
Tick one of the following answers (none, primary, secondary, college) according to the subjects highest education level completed.

Q6: What languages do you speak (check all that apply)?
Check all the languages that the subject speaks locally. If the subject can speak French, English, or German check others and place language in the box.

Q7: Current Martial Status
As of the day of enrollment what is the martial status of the subject.

Married (monogamous) -is the subject married formally
Married (polygamous) -is the subject married to multiple partners formally Steady boyfriend/girlfriend -is the subject have a regular partner Single -the subject is not currently in a relationship Divorced/Separated -the subject was previously in a marriage Widowed -the subject was in a marriage until their partner passed away Q8: Employment Ask the subject what current occupation.
Salaried -does the subject get regular payment for their work Self-employed -does the subject own has his/her own business, sets his/her own hours, makes their own products, ect.
Casual Laborer -is the subject currently in a short-term employment; ie house keeper Unemployed -currently the subject is not working Q9: Do you have a steady partner?
Please tick yes or no if the subject is currently has a steady partner.
Q10: How long have you been with your current partner?
Tick the box that corresponds to subjects length of time with current partner Q11: Partner's Employment: Ask the subject what current occupation of his or her partner.
Salaried -does the subject get regular payment for their work Self-employed -does the subject own has his/her own business, sets his/her own hours, makes their own products, ect.
Casual Laborer -is the subject currently in a short-term employment; ie house keeper Be as specific as possible when it comes to describing the location, physical address, directions to residence and useful local landmarks.

Knowledge Assessment Form
This questionnaire is primarily filled by the lab technologist.
The purpose of this form is to assess the patient's subjective knowledge about antiretroviral medications and HIV.

Study ID number
This is the unique research identification number that is given by the study coordinator at the time the subject enters the research study.

Interviewer number
This is a unique code given to all interviewers in the study staff. If you do not have an interviewer numbers please contact the data manager.

Date of the interview
Provide the current date that the interview is taking place. Information on dates should be recorded as day (dd), month (mm), year (yyyy).

Loss To Follow-up Form
This questionnaire is primarily filled by the Study Coordinator The purpose of this form is to provide information on subject that have not returned to clinic.

Study ID number
This is the unique research identification number that is given by the study coordinator at the time the subject enters the research study.

Interviewer number
This is a unique code given to all interviewers in the study staff.

Researchers' Statement
You are being asked to join this research study of HIV/AIDS because you are > 18 years old, are coming to the Hope Center for care, are eligible to start taking anti-HIV medications for the first time, and will allow home visits. You are also being asked to allow storage of samples of your blood that are not used immediately for this study but will be used for future studies of HIV/AIDS. The people in charge of this study are named above.
The purpose of this consent form is to give you the information you will need to help you decide whether to be in the study or not. Please read the form carefully. You may ask questions about the purpose of the research, what we would ask you to do, the possible risks and benefits, your rights as a volunteer, and anything else about the research or this form that is not clear. When we have answered all your questions, you can decide if you want to be in the study or not. This process is called 'informed consent.' If you wish, we will give you a copy of this form for your records. Deciding whether or not to be in the study will not affect your ability to receive medical care and treatment from the Hope Center in any way.

Purpose of the Study
The goal of this study is to learn the best way to help people starting anti-HIV medications for the first time to take these medications correctly. This study will compare whether education counseling, an alarm device, both education counseling and the alarm, or neither of these is better to help people take their medications.

Procedures
Group Assignment If you are eligible and agree to join this study, you will be randomly assigned to one of four groups:  a group that will receive 3 education counseling sessions from a counselor about how to take anti-HIV medications correctly;  a group that will carry an electronic alarm device for six months to help remember when to take anti-HIV medications;  a group that will receive both education counseling and carry the alarm device for six months;  and a group that will receive usual care but neither alarm device nor education counseling Random assignment is like "flipping a coin", you have an equal chance of being in any one of these groups. We won't know which intervention you will receive until we open the envelope that has a sheet of paper telling us which intervention you will get. Neither you nor we choose your intervention. Rather, the envelopes contain papers assigning the interventions and we can't know until we open the envelope which one you will be assigned to. About 400 women and men will take part in this study, and 100 people will be in each group.

Interventions
 In the education counseling intervention, you will meet with a counselor who will counsel and educate you on HIV/AIDS and the importance of taking anti-HIV medications. You will meet with the counselor twice before you start taking anti-HIV medications and once after you start. The first two sessions will occur approximately one week apart and last approximately 45 minutes each. The third session will occur one month after starting medications and will last approximately 45 minutes. These sessions will occur here at the Hope Center. The counselor will make sure you know how to take the medications properly, and will explore with you different ways to improve your adherence to anti-HIV medications.  In alarm device intervention, you will be given an alarm device that will be individually programmed to your medication schedule. It is a small device that will fit in your pocket. At the time you are required to take the medications, the alarm will beep until you shut it off. You will be asked to carry the pocket alarm device at all times and use it to remember when to take your medications. You will use the alarm for 6 months after you begin taking anti-HIV medications, then you will return the alarm to the study. You will continue to be followed in the study after you return the alarm to see if you can still remember when to take the medications without depending on the alarm.  All groups will receive counseling on how to take anti-HIV medications from the pharmacist. The group which receives neither educational counseling nor alarm device will still receive information on use and side effects of the drugs from the Study Pharmacist. Those people in the groups which receive 1) only the alarm device or 2) neither alarm device nor education counseling; will not receive the additional medication counseling that they would receive if they were only seen at the Hope Center and not enrolled in the study.

First Visits
At the beginning of the study, you will be:  asked to tell us where you live and how we may contact you in Nairobi and your upcountry home  asked to complete a series of questions (a survey) that will include your health, sexually activity, and knowledge of how to take anti-HIV medications  accompanied home by a counselor to collect information about your living conditions and distance from clinic. We will do this to see how these things may affect your ability to take anti-HIV medications, to give you social support at home, and to be able to trace you if you do not return to the research clinic. Your home location will be put into an electronic mapping device (GPS).  given one 10-minute counseling session with the pharmacist who will explain side effects associated with the medications and the importance of taking them properly Follow-up Visits Once you enter this study, we will ask you to take part for 18 months. You will be asked to return every month to pick up your anti-HIV medications from the study pharmacist. You will be asked to bring your pill bottle with you and the pharmacist will count the number of pills you take by hand or electronically. Also, when you pick up your medications, someone from the study will ask about your adherence to your anti-HIV medications in a 5-minute interview. One month after starting anti-HIV medications and then every 3 months thereafter, we will also assess your knowledge of anti-HIV medications in a 10-minute interview.

Blood samples
At the first visit, 6 months, 12 months, and 18 months after you enter the study:  you will have about 7 ml (about 1.5 teaspoons) of blood drawn by study staff that will be stored. This blood samples may be sent to Seattle, U.S.A. to test for the amount of HIV virus in your blood and antiretroviral resistance unless viral testing and analyses are available locally  in total, 4 vials of blood will be removed over 18 months for study purposes  some of the blood will be stored for future HIV-related studies and will not be used for immediate testing. All names and identifying information will be removed after completion of the study in January 2011.
Hope Center You will continue to receive medical care and antiretroviral treatment at the Hope Center now and after the study is complete. Your HIV medical care will be handled by Hope Center physicians and not by this research study. They will give you medications and may order other laboratory tests as they see fit. We will have access to your medical records at the Hope Center and will follow your medical course on anti-HIV medications. We will dispense the anti-HIV medications that the Hope Center physicians prescribe. If you have any medical problems, you will contact the Hope Center for care and treatment.

Risks and discomforts of being in the study
The study may collect personal information from you that may be embarrassing to talk about and may cause some distress or discomfort. For example, you may be asked how many sexually partners you have had. You do not have to answer any questions you do not wish. If any distress occurs, you will see one of our nurse counselors. As part of the study, you may meet other patients from this clinic whom you know from outside the clinic. We will be collecting blood samples from you using a needle and syringe. The puncture of the needle may be uncomfortable and leave a bruise. We will also accompany you to visit your home to assess how you live and where your home is located. Having someone visit you in this way may make you feel uncomfortable or draw undesired attention from neighbors. There is also a possibility of invasion of privacy from the alarm devices if you are in one of the groups that receives the alarm.

Alternatives to Participation
You may choose not to be in the study. If so, you will continue to receive anti-HIV medications and medical care from the Hope Center. You will also still receive counseling on anti-HIV medications from both the pharmacist and the adherence counselor at the Hope Center in at least three educational sessions. You may also choose to receive treatment and testing from other doctors, local clinics, and hospitals in Nairobi. The study staff will discuss all options available to you.

Benefits of the Study
You may benefit from this study by increasing your ability to take your anti-HIV medications correctly. You may also receive no direct benefit from this study. The results of this study may show ways to help people take anti-HIV medications correctly.

Other information
Information about your diagnosis is confidential and we will keep your records in a locked office. Information about your diagnosis and your participation in the research will be available to you and to the study team but not to anyone outside of the study. Data and blood samples obtained from you will be kept indefinitely, but all identifying information on data and blood samples will be removed after completion of the study in January 2011. Some blood will be kept for future studies in HIV/AIDS. In order to be in the study, you must agree to collection and storage of your blood for testing.
There is no cost to you for participating in the study. You do not have to pay for any study visits, testing, counseling, or the alarm device. You will also not receive any money for participating in this study.
You may refuse to participate or may withdraw from the study at any time without penalty or loss of benefit to which you are otherwise entitled. Your relationship with staff and services at Hope Center for Infectious Diseases will not be affected in any way if you do or do not participate or if you enter the program and withdraw later.
The following groups may need to review study records about you: Institutional oversight review offices at the research site, the University of Washington, or state and federal regulators.
Questions about the study or any adverse events should be addressed to this investigator, the study nurse, or Dr. Michael Chung. Do you have any questions? Do you agree to participate?

Subject's statement
This study has been explained to me. I volunteer to take part in this research. I have had a chance to ask questions. If I have questions later about the research, I can ask one of the researchers listed above. If I have questions about my rights as a research subject, I can call the Ethical Review Committee at Kenyatta National Hospital 272-6300. I will receive a copy of this consent form if I would like one.

Signature of subject _________________________________ Date ________________
Printed name of subject____________________________________ copies to: Investigator and Subject

Data Safety and Monitoring Plan
The length of study enrollment is projected to be 1 year, and it is planned that CD4 counts and HIV-1 viral analyses will be collected every 6 months for each patient who will be followed for 1 ½ years. Since viral investigations may be done in Seattle, it may take another 6 months before these tests are performed. Given the variation in time between enrollment, collection, and testing of specimens, statistical comparisons of CD4 counts and HIV-1 viral loads between the two groups will be analyzed at 3 objective time points throughout the 5 year life of the study. At first when 25% of the testing data is available for analysis, second when 50% of the data is available and third when 75% of the data is available. If analyses show statistically significant and consistent differences in CD4 counts and HIV-1 viral loads between any two arms in the study over a period of a year, then the primary and co-investigators of the study will meet to discuss stopping or revising the interventions. This data and safety monitoring plan has been formalized as part of the study protocols, and a committee has been formed.