PONE-D-20-31594

Young at risk-people in Maputo City, Mozambique, present a high willingness to participate in HIV trials: results from an HIV vaccine preparedness cohort study

PLOS ONE

Dear Dr. Capitine, 

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.

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We look forward to receiving your revised manuscript.

Kind regards,

Karine Dubé, DrPH

Academic Editor

PLOS ONE

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2. Please provide a sample size and power calculation in the Methods, or discuss the reasons for not performing one before study initiation.

3. Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed a questionnaire as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information.

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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

Reviewer #3: Partly

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: 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: No

Reviewer #3: No

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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

Reviewer #3: Yes

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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: Kudos for your success in enrolling and following this sizable cohort for 24 months.

INTRODUCTION

I note your statement that the importance of WTP factors varies over time and contexts (lines 67-68). How then should we assess the meaning of the findings of these interviews done between 2013 and 2017? Has the epidemic changed? Have attitudes changed?

The fact that 2 HIV vaccine trials have been conducted in Mozambique (including a Phase 2 trial) and more are currently under way seems like the best, most concrete demonstration of WTP (lines 57-60). Might there be information about enrollment and follow-up from those trials that would be relevant to the discussion of this WTP study?

RESULTS

The cohort comprises young people at substantial risk of HIV infection, the great majority of whom are aware of that risk. It seems like an ideal target for HIV vaccine trials. So the high WTP percentages are no surprise to me.

The low loss to follow-up (LFU) and the continued high WTP at the end of follow-up testify to a well-done study that treated the participants well!

Line 209: you state that motives for not participating increase during follow-up. I do not see the evidence for that.

Table 3: the OR for "required to receive the vaccine a few times" increased from 14.8 to 104.8 after adjustment. I have never seen an aOR that high! Can you look more deeply into the data to find out what is going on? Perhaps some major collinearity.

Table 3: The factor "required to use contraceptive" is associated with an increased WTP. In Table 2, that factor seems to reduce participants' WTP. (The Meque study also found that a family planning requirement would be a barrier for some women.) Can you examine that further? In Table 2, you show data for women only. Perhaps the results in Table 3 include the responses from both women and men?

DISCUSSION

Lines 264-265: you state that the cohort derives from the general population. I would reiterate that they are nevertheless at substantial risk of contracting HIV, as borne out by numerous prevalence and incidence estimations.

Line 282: rather than "the correct information" I would write "more accurate information."

Lines 283-285: I am not clear on your argument here. Table 2 shows that the perceived value or salience of the potential benefits of vaccine trial participation diminished during follow-up. But knowledge of the potential benefits would not go down, would it? Admittedly, in line 305 you write that no information was given to them on features of potential vaccine research. But I would say that their responses about possible personal benefits shown in Table 2 reveal a pretty clear idea of what a vaccine trial might offer.

Lines 321-325: your brief discussion of limitations made me curious whether there was a larger cohort that was created for RV 363, since you refer to the RV 363 incidence cohort in line 323. I looked at reference #19, but it describes only the cross-sectional findings from the baseline screening of 1125 participants. Was the larger cohort also followed for 24 months? If so, can you provide the LFU figure from the entire RV 363 study? That seems like a very relevant and important piece of data to help interpret these findings from a subset of participants. It could be inserted into the section Study Design and Populations, and then discussed in limitations. If only the 577 participants described here were followed prospectively, then these questions of mine are irrelevant.

Reviewer #2: General comments:

This study looks at the willingness to participate in a HIV vaccine trial among young adults at a suburban area in Maputo City, Mozambique. Authors assessed factors and barriers to WTP in a hypothetical HIV vaccine trial. This is quite an interesting manuscript, and the authors set out the aims quite clearly. However, there is a need to explore the uniqueness of the manuscript given that there is a relatively extensive literature on factors about WTP in HIV vaccine trial in different African populations as well as strengths form this study.

Some specific points need authors consideration:

Introduction

The authors mentioned that there are already studies conducted in Africa assessing factors associated with WTP, including in Mozambique; so, what is new about the current study that other studies did not assess? Authors may need to explore additional gaps to justify the need for this study.

Methods

Authors may need to provide additional description of all variables in the methods section.

Lines 120- 121: how many participants answering do not know, refused to answer, someone else should decided etc were removed from the analyses? This need to be specified.

Line 130: What are willingness to participate factors? Is this different from the willingness to participate (the dependent variable)? This is not clear ; How motives and barriers to WTP were assessed? This is not clear in the methods section

How the authors defined perceived risk for HIV infection? How was this explanined to the participants?

Results

Table1. How the authors define perceived risk for HIV infection? See comment above

Figure 1 is missing

Table 2: Do WTP factors the same as HIV vaccine knowledge? please see comment above on line 130

Table 3: Title … analysis of selected factors for willingness to participate… Please replace "for" by "associated" to make the title more clear.

How do the authors explain the finding of volunteers requiring to be injected with an HIV vaccine express WTP, and on the other hand, fear of needles a barrier?

Table 4: perceived risk for HIV infection was not significant. Authors may reconsider from including it as a factor associated with WTP in a vaccine trial

Discussion:

Lines 261-262- authors mentioned the need for WTP studies to target women… and line 267 – authors found high rates of WTP for men and women. Did the authors assess gender differences in the WTP in the current study? How WTP differs from men and women in the current study at screening and exit visits? Given that this study has a gender balance in participation authors may want to assess gender differences in factors and barriers to WTP in a vaccine trial.

Line 287: I am not entirely clear about this sentence, as the authors did not assess this factor in the current study. Did the authors find gender differences in assessing the barriers to participating in vaccine trials? Please see comment above.

Lines 312-314: A substantial percentage (25%) of the participants did not complete the WTP questionnaire at the exit visit. With such a considerable number of participants, the author may need to provide potential explanations and assess the characteristics of this group. How this group of participants (n=147) differ from the group who answered no to the WTP questionnaire at the exit visit? Could the authors discuss their similarities and differences?

Lines 322-324: The authors discussed the limitations of the study. Can the authors discuss the generalizability of this study? What % of participants came from different suburban areas other than Polana Caniço? This is a relevant issue in this study as if I understood the majority o participants are from Polana Caniço area.

Along these lines, it is also essential to discuss the strengths of the study as this can add more relevance to the study.

Reviewer #3: General Comments:

This study assessed factors associated with willingness to participate in potential HIV vaccine trials by conducting a 24-month observational cohort study among high-risk people in Maputo City, Mozambique. The analyses presented make use of data collected during a 24-month prospective HIV incidence study. As currently formulated, the analyses do not provide new insights into who might be interested – and who should be the focus of – future HIV vaccine trials. As in several studies, willingness to participate is most associated with HIV risk perception and/or altruism. The study could benefit from inclusion of HIV incidence (which I believe was the main outcome of the parent study) in models of WTP. In addition, some of the measures used in this study likely suffer from self-presentation bias. It might be more informative to compare likert scale response options (“very” likely versus other categories) than to simply collapse into bivariate variables. Finally, the authors should provide a more thorough discussion in the introduction and discussion sections about differences between “willingness” and actual behavior.

Introduction:

1) The authors should consider how to strengthen the introduction and justification for the research presented in this manuscript. Specifically, the introduction should address the idea that hypothetical “willingness” may not correlate with actual behavior and, to the extent possible, identify any factors that do strongly correlate between the two. Given that barriers and facilitators of trial participation vary widely over time, population and context, what can we learn from these kind of studies?

Methods:

2) Based on description of this study, participants enrolled in an HIV incidence study that did not entail receiving any kind of “vaccine-like intervention”. In order to interpret findings related to “willingness”, it would be useful to provide the actual script that described what participation in an HIV vaccine trial would entail.

3) What proportion of participants who joined the HIV incidence study responded to questions about willingness to participate in future HIV vaccine trials? (It is unclear whether the 570 of 1150 screened volunteers related only to the “willingness to participate” sample, or to the parent study in which these data were collected.

4) Were questions administered via tablet, or on paper? (I assume face-to-face interviews, correct?)

5) It looks like the main willingness question was bimodal. However, the “barriers” question with likert scale responses also seems to be to be more about willingness than barriers. If specific barriers to participation were assessed, please provide an idea about these items. The same would be useful for the “facilitators” items.

Results:

6) Given the lack of variation in the willingness to participate variable, the authors might consider focusing their analysis on the “barriers” variable instead, maintaining the 4 point likert response scale.

7) It is interesting that all perceived benefits of trial participation dropped between screening and exit. Do the authors have any ideas about why this is, or who participants were that have a decrease in perceived benefits over time?

8) Given the likelihood of self-presentation bias, it might be useful to examine and/or provide data for strongly agree category versus other categories related to willingness to participant if various tests, procedures required.

9) It appears that willingness to participate largely driven by risk perception for this study. How does this compare to other studies?

Discussion

10) The statement about the “practicality” of conducting willingness to participate studies seems overly positive. WTP studies are expensive and themselves may be considered interventions that drive incidence down – so promoting them as practical is not very convincing. It would be useful to show how such trials can help to better target the right kind of participants, recruit and retain them.

11) Line 254/page 18 – “study” redundant.

12) The discussion brings to mind that this study would be strengthened if the authors included HIV incidence as covariate in the models. Are those who are willing to participate also most likely to be at risk of HIV? It is particularly important to determine ways to recruit participants from the general population who are in fact most likely to be at risk of HIV – those who are altruistic are also likely to be at lower risk.

13) Changes in source of information – YES, of course. These studies are interventions in themselves. But, not a practical way to inform people about HIV vaccine trials.

14) Study limitations should identify self-presentation bias.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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PONE-D-20-31594R1

Young at risk-people in Maputo City, Mozambique, present a high willingness to participate in HIV trials: results from an HIV vaccine preparedness cohort study

PLOS ONE

Dear Dr. Capitine,

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 June 26, 2021. 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. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Karine Dubé, DrPH

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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 #1: All comments have been addressed

Reviewer #2: (No Response)

Reviewer #3: 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 #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

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

Reviewer #1: Yes

Reviewer #2: I Don't Know

Reviewer #3: Yes

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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 #1: Yes

Reviewer #2: (No Response)

Reviewer #3: Yes

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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 #1: Yes

Reviewer #2: (No Response)

Reviewer #3: Yes

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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 #1: (No Response)

Reviewer #2: I again congratulate the authors for such an interesting paper that helps to advance evidence of HIV vaccines. I also thank the authors for addressing the majority of issues in the manuscript. However, there are still some issues that need authors consideration as they are relevant. I leave to the Editor to decide the paper's outcome, to accept as it is, or to request another revision based on the reviewer's findings.

1. One issue is related to the interpretation of a borderline/ non-significant result on table 4. Significance and non-significance are based on an arbitrary cut-off of 5% and as such one needs to interpret according to the study context. Although I understand authors need report their bordeline result, I still believe authors may not report it as it is a significant finding, without a further explanation. Instead, they may need to discuss the meaning of this finding in terms of their impact or so. This may be an issue with sample size, but the meaning needs to be discussed. On page 19 (see below the text extract), the authors report the same findings as purely significant. This in my view, needs attention.

"Among the 430 participants who stayed through the course of the study, results from the GEE

265 binary logistic regression (screening visit and exit visit) showed that perceived risk for HIV

266 infection (aOR 1.90, 95% CI: 0.99-3.63),… were associated with willingness to participate in HIV vaccine studies (Table 4)."

k.Table 4: perceived risk for HIV infection was not significant. Authors may reconsider

from including it as a factor associated with WTP in a vaccine trial

R: We thank you for your comments. The Perceived risk was borderline significant

p=0.053. We believe this trend should be considered.

2. The second issue is related to the limitations of the study that needs to be clearly addressed. In my previous revision, I raised the issue of the generalizability of the study that needed to be discussed. However, the authors mentioned that this issue would be addressed in another paper, not the current one (see below the authors’ answer). I still believe that the issue of generalizability needs to be mentioned in this paper. There are other issues that were postponed to a future paper, but are also important in the current paper.

o.Lines 322-324: The authors discussed the limitations of the study. Can the authors

discuss the generalizability of this study? What % of participants came from different

suburban areas other than Polana Caniço? This is a relevant issue in this study as if I

understood the majority o participants are from Polana Caniço area.

R: We thank you for the comments. Data will be used in another manuscript (incidence

paper).

3. The third issue is acknowledging the self-presentation bias that another reviewer (#3) had raised, but was not addressed by the authors. I also state that these type of studies are highly influenced by social desirability bias—this need to be considered in the limitations and actions to minimise it stated.

Reviewer #3: (No Response)

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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.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

[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: Revision 2_ WTP paper.docx

Young at risk-people in Maputo City, Mozambique, present a high willingness to participate in HIV trials: results from an HIV vaccine preparedness cohort study

PONE-D-20-31594R2

Dear Dr. Capitine,

We are pleased to inform you that your manuscript has been judged potentially scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Please kindly note two final proposed comments from the Academic Editor.

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,

Karine Dubé, DrPH

Academic Editor

PLOS ONE

Additional Editor Comments:

• We strongly encourage the authors to cite previous similar research in Mozambique ()https://pubmed.ncbi.nlm.nih.gov/25555105/). 
• The authors should adhere to the NIAID Language Guide (https://www.hptn.org/resources/HIVLanguageGuide). The expression 'HIV-infected' and 'HIV-uninfected' are now considered stigmatizing. We encourage person-first language as much as possible (e.g., people with HIV, people without HIV).

Reviewers' comments:

N/A