PONE-D-20-15557

Vaccines safety and maternal knowledge are determinants of maternal immunization acceptability in rural Uganda – A Qualitative Study Approach.

PLOS ONE

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PLOS ONE

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This work was supported by the GCRF Networks in Vaccines Research and Development which was co-funded by the MRC and BBSRC. Grant Number: IMPRINT Network-ITCR079018.  The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.'

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This novel study is an in-depth exploration of the attitudes and knowledge regarding maternal vaccination held by pregnant women and health workers in Uganda. Though many women were aware of the importance of maternal vaccination, there were many misperceptions. Both pregnant women and health workers reported that many women use traditional medicine as a means of prevention, rather than vaccination. A barrier for 12% of the women were that they belonged to Pentecostal churches and thus are forbidden from vaccination. Participants mentioned that there are only 2 days per week that they can visit a health clinic for vaccination; some said that the clinics were dirty, but more disturbingly, many women experienced abusive or lazy behaviour from health care workers. The authors reported that many of the women had safety concerns about vaccination, as did their husband/s, particularly regarding new vaccines. Many of the participants spoke about their husbands’ involvement in vaccination: some were supportive, but some said their husbands were embarrassed by their wife’s appearance, and some did not accompany them to the clinic. The results need to be published as a means to working towards improving pregnant women’s knowledge on vaccination and vaccine-preventable diseases, improving rural Ugandan women’s access to safe health services, and subsequently increasing maternal vaccine uptake. Thank you for the opportunity to read and review this important paper.

MAJOR COMMENTS:

1. Introduction

a. Given many of the women had safety concerns, and the authors suggest utilising a vaccine safety system, vaccine safety should be discussed in the introduction. Some suggested literature (though only on influenza):

i. Foo DY, Sarna M, Pereira G, Moore HC, Fell DB, Regan AK. Early childhood health outcomes following in utero exposure to influenza vaccines: a systematic review. Pediatrics. 2020 Aug 1;146(2).

ii. Giles ML, Krishnaswamy S, Macartney K, Cheng A. The safety of inactivated influenza vaccines in pregnancy for birth outcomes: a systematic review. Human vaccines & immunotherapeutics. 2019 Mar 4;15(3):687-99.

b. A brief comment on what’s known generally on the facilitators and barriers of maternal vaccination is warranted. Suggest reading and citing the following:

i. Kilich E, Dada S, Francis MR, Tazare J, Chico RM, Paterson P, Larson HJ. Factors that influence vaccination decision-making among pregnant women: A systematic review and meta-analysis. Plos one. 2020 Jul 9;15(7):e0234827.

c. Thematic framework and figure 1:

i. I like this figure. However, it is not clear to me where the ideas have come from? Did the authors refer to other models/theories, such as the Social Ecological Model?

ii. A description on why environmental factors were considered to be the underlying factors to vaccine acceptance is needed.

2. Methods

a. Participant recruitment and data collection:

i. When did the authors stop recruiting? Did they aim to get 10 FDGs and 5 KIIs from 5 villages and 90 women? Or is this when they felt they had reached ‘data saturation’?

b. Research tool

i. an explanation of who developed it and how it was developed is warranted

c. Data management and analysis:

i. Who translated and transcribed the audio recordings from Lusoga to English? And who translated them back from English to Lusoga? Was there consistent

ii. The authors say DK and MM developed the initial codebook. What is their experience with qualitative analysis? I note that their education is provided on page 1, but it is worthwhile positioning their level of expertise here too.

d. Research validity and reliability:

i. How did the study site team members provide a conducive environment?

ii. How trained the researchers on how to document verbal and non-verbal responses?

3. Results

a. How was the information for Table 1 collected? Was it self-report on a form? Or were participants asked in the focus group interviews?

b. There are a lot of brilliant quotes. However, having so many disrupts the flow for the reader. As many of the quotes are already summarised in the sentence before it, and therefore the quotes don’t add anything extra to that point, I suggest removing the quotes on the following lines:

i. Line 281

ii. Lines 287-288

iii. Lines 293-294

iv. Line 300

v. Lines 327-328

vi. Lines 360-362

vii. Line 393 (and instead add the word “reminders” to the sentence “…husbands in decision making and reminders regarding vaccination...”).

viii. Line 398

ix. Lines 403-404

c. Similarly, to help the flow of reading for the reader, I think the results in section 3.3 should be reformatted, to include all the positive comments or comments about convenience at the beginning, followed by all of the negative comments or comments about inconvenience at the end. It is currently mixed.

d. Lines 416-421. This is a striking result. I think the authors could make this section clearer, however. Furthermore, I understand that polygamy is legal in Uganda; when the participant on line 420 says “One says I will not go….” is this one of her husbands?

4. Discussion

a. There are a lot of bold statements in the discussion, that haven’t been referenced. Please either reword or find references. Some examples of unreferenced bold statements:

i. Lines 448-449: “For example, a woman who gets vaccinated and later develops a disease like malaria may fail to seek for future vaccination.”

ii. Lines 453-454: “With decreased perceived risk of immune-preventable diseases, fear for AEFI increases which may reduce compliance with vaccination.”

iii. Lines 457 – 459: “Pregnant women generally have trust and high expectations in the safety of maternal vaccines. Women are emotionally attached to their pregnancies and highly consider the wellbeing of their child….”

b. I’d be interested in reading about the abusive behaviour some health care workers have towards pregnant women. Do other LMIC countries experience this? Given a health care providers recommendation is one of the most important facilitators of vaccination, what’s the impact of the abusive behaviour on uptake? It would also be worthwhile noting that while health care workers should receive training on using consistent messaging (Lines 551-552), some appear to need training their behaviour and bedside manners.

c. I’d also be interested in reading about the impact of husbands on maternal vaccination. For example, the shaming husbands do of their wives’ appearances and clothes. Has this been documented anywhere else in the literature? Given husbands were also important in decision-making, how does this work in polygamous relationships? Finally, given that some women weren’t able to access health clinics as their husband would not accompany them, is home vaccination an achievable, acceptable and safe option for women in Uganda? Are there any other health services delivered in the home?

d. To me, there was also a theme about cleanliness/dirtiness. Some health workers abused patients if they were dirty, some women reported on dirty toilets at clinics, and some women said their husbands wouldn’t go with them to the clinic as the women were dirty. Further discussion about this, with potential solutions if there are any, would be interesting.

e. Safety surveillance: whilst this important, I’m not sure whether this is the first strategy that should be implemented. It’s also costly and will take time to implement. Consider other more-immediate interventions that may help these women. Some guidance in these papers:

i. Krishnaswamy S, Lambach P, Giles ML. Key considerations for successful implementation of maternal immunization programs in low and middle income countries. Human vaccines & immunotherapeutics. 2019 Apr 3;15(4):942-50.

ii. Ellingson MK, Dudley MZ, Limaye RJ, Salmon DA, O’Leary ST, Omer SB. Enhancing uptake of influenza maternal vaccine. Expert review of vaccines. 2019 Feb 1;18(2):191-204.

MINOR COMMENTS:

5. Title

a. The title should be revised. The word “determinants” is usually reserved for studies that have utilised quantitative methods.

6. Article summary

a. Line 56: Is this about women in Uganda? And about maternal immunisation?

7. Key words

a. Suggest using more specific MeSH terms, such as “Health Knowledge, Attitudes, Practice” and a term to describe Uganda

8. Introduction

a. Some of the sentences are quite long (e.g. lines 69-72). Consider shortening

b. It’s important that the references used directly relate to the topic. For example, line 71 discusses tetanus, but reference #2 is not about tetanus\\

c. Line 86: How was 40% update for TT2+ estimated? What data was collected/used? Is it a reliable estimate?

d. I suggest using systematic reviews as much as possible in the introduction. For example, the following systematic review should be referenced:

i. Nunes MC, Madhi SA. Influenza vaccination during pregnancy for prevention of influenza confirmed illness in the infants: a systematic review and meta-analysis. Human vaccines & immunotherapeutics. 2018 Mar 4;14(3):758-66.

9. Methods

a. When was the study carried out and how long did it go for? It would be worthwhile adding the year/s and duration into the ‘research method’ section

b. Participant recruitment and data collection:

i. As the reader, it would be clearer to move lines 157-162 to line 153, after “interviews at both the community and health facility.” This will help the reader understand how the research team purposively selected participants

10. Results

a. Table 1:

i. Given the numbers are <100, it is advisable to round the % to the nearest whole number

ii. The total number in religion does not equal 90

iii. A space is needed between the numbers and brackets

iv. Please spell out what TT means (underneath the table)

b. Knowledge about maternal vaccines and immunisation:

i. Please clarify whether this sentence “Many were able to mention that vaccination prevents mothers and children from diseases like tetanus, measles, etc” is referring only to vaccination during pregnancy, or vaccination of people in general?

c. Lines 357-358. I think the authors could expand on this and define what they mean by “sensitization.”

d. Line 383: I suggest removing the Ugandan President’s name, and just refer to them as the President of Uganda. I.e., you would write “we are prepared but the problem is that they tell us that [The President of Uganda] wants to test the drugs on us….”

e. Lines 409-410: This quote doesn’t relate to the sentence above it. Consider using another quote.

f. Line 421: Should “rugs” be “rags”?

11. Discussion

a. Lines 439-440: distinction is needed as to whether participants are talking about vaccination prior to pregnancy, or whether pregnant women think they haven’t yet been vaccinated against hepatitis B or HPV in their pregnancy?

b. Line 442: suggest using the word “prime” here instead of “encourage”

c. Line 453: please reword “immune” to “vaccine.”

Reviewer #2: Review of manuscript for PLOS ONE

Summary: This is a well done manuscript. The title, background, findings, and discussion are very well laid out. Methods need some clarity for reproducibility. Just a few suggestions to make it a little more crisp:

Comments on

Title: No comment

Abstract:

Lines 33 &34: You need to recast this sentence. “Women expressed willingness to take new vaccines, positive attitudes towards maternal immunization, and were familiar with its importance”. Recast the sentence to follow the order in your objectives namely knowledge, attitudes and willingness. For example: “Women were familiar with the importance of maternal vaccines, have positive attitudes and expressed willingness to take them”.

Line 35: “……... affected by adverse events”, ie changing the effects to events. Also recast the statement to be more sharp and crisp. Such as “………. affected by worries of pregnant women and that of their partners’ who influence health seeking decisions in a home concerning adverse events following the martenal immunization.”

Line 36-38: “Misconceptions about introduction of vaccines like thinking that vaccines will be tested on only them before introduction in larger population, and that vaccines treat illnesses like malaria and general body weakness.” Consider this phrase “ …… of vaccines such as the belief that vaccines treat malaria and general body weakness and that of being used as guinea-pig to test for the vaccine before its introduction to the larger population.”

Background:

Line 77: It is World Health Organization and not “world ….”

Line 80: “………. are administered to pregnant women.”

Line 82: Do you mean that poor neonatal health outcomes are due to lack of studies on knowledge ………. Make it clearer.

Line 87: Be consistent. “ Immunisation” is British English. You have been using American English. In addition, there is a little flaw in the content and mechanical accuracy in that sentence. You could consider “This can partly be attributed to limited knowledge among pregnant women, their poor attitude about immunization, their failure to attend all ANC visits, lack of training of the Village Health Teams (VHTs) on the importance of TT vaccination for pregnant mothers and limited health education to pregnant mothers.”

Line 92: “ ………. middle-income countries in respect of Pneumococcal Conjugate Vaccine ……….. “

Line 95: GAVI means Global Alliance for Vaccines and Immunizations.

Methods: This section need some work.

Line 144: You had included health workers in the research population included. You failed to include them now.

Line 153: Which of the population had FGD and which one had KII. You need to be coherent and orderly.

Line 157: Readers may find it difficult to understand what you mean. I think you may look at it again and recast it to bring out your points clearly.

Line 165: Order and sequence is important as mentioned in previous comment.

Line 174: Pointless mentioning names of those that played a role here.

Results:

Line 194: “ (2 FGDs pregnant women and 2 health workers) could read “(2 FGDs for pregnant women and 2 KIIs for 2 health workers)”, or what exactly, do you have in mind.

Line 208: Change the FDG to FGD. Where exactly is the study area; rural or urban or rural and semi-urban? Be consistent.

Line 239: You use either “reason” or “why”.

Line 250: I could have preferred “….one woman added” than the word chipped in. This is scientific writing.

Line 264: AEFI means adverse events following immunization. It refers to any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.

Line 283: could read “ …… highlighted that some of ……”

Line 290: “Participants also expressed that some pregnant women did not go for vaccination due to their prohibitive religious practice like some Pentecostal churches”, could read “Participants …….. due to their religious belief that prohibited vaccination”.

Line 296: This statement “Some mentioned the fear for injections and HIV testing (which is compulsory for all women attending ANC) would be the reason why some women do not seek maternal vaccination” could read “Fear of injections and HIV testing could be the reason some women fail to seek maternal vaccination.”

Line 369: “When health workers were asked what women are worried about, only one mentioned AE worries from the pregnant women and their partners” could read “When health workers were asked what women are worried about, only one mentioned that the pregnant women and their partners were concerned about AEFI.”

Line 375: The statement could be rephrased thus “Some participants believe that they were used to test for the safety of new vaccines and thus they would not take the vaccines until its safety is confirmed by others who had received it.

Line 389: Could be rephrased as “Pregnant women …………. vaccination even without accompanying them and their children to immunization centers.”

Line 400: You may want to rephrase thus “Health workers cited that they encouraged pregnant women to come with their partners for ANC visits.”

Line 417: “…………. not effective since women are not comfortable with moving with husbands and more so their husbands don’t dress well.”

Discussion:

Line 434: be consistent with the study area.

Line 452: change adverse effect to adverse event

Line 475: Rephrase as “…………... and religious practices found in some Pentecostal churches, that prohibited maternal vaccination.

Line 482: Rephrase the statement for clarity

Line 486: Rephrase the statement. It could read “Some believe that the new vaccines …………...”

Line 502: delete treatment from the sentence.

Line 504: You can rephrase as “The attitudes and behaviors of health care providers towards pregnant women is an …….”

Line 517: Consider rephrasing thus, “……… get vaccinated for their good and that of their children”.

Line 518: Consider this rephrasing “The partner’s worries about AEFI was an important concern for women ………….”

Line 537: See the comment on line 34

Line 538: Define ADR. Do you mean Adverse Drug Reaction? Since we are talking of immunization why not use AEFI instead.

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Reviewer #1: No

Reviewer #2: Yes: Dr Uchechukwu Joel Okenwa

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Attachments

Attachment

Submitted filename: Review of manuscript on maternal immunization.docx

PONE-D-20-15557R1

Vaccines safety and maternal knowledge for enhanced maternal immunization acceptability in rural Uganda – A Qualitative Study Approach.

PLOS ONE

Dear Dr. Kajungu,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Dec 14 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Holly Seale

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #2: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #2: No

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: Good job. You just need to re-read the article painstakingly for few grammatical errors, most of which I have pointed out. See the attachment.

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

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Reviewer #2: Yes: Dr Uchechukwu Joel Okenwa

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

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Attachments

Attachment

Submitted filename: Review2_Maternal Immunization Acceptability Manuscript.docx

Vaccines safety and maternal knowledge for enhanced maternal immunization acceptability in rural Uganda – A Qualitative Study Approach.

PONE-D-20-15557R2

Dear Dr. Kajungu,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Holly Seale

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: