PONE-D-23-10021An instant messaging mobile phone application for promoting HIV pre-exposure prophylaxis uptake among Chinese gay, bisexual and other men who have sex with men: A mixed methods feasibility and piloting randomized controlled trial studyPLOS ONE

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Reviewers' comments:

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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: Partly

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?

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Reviewer #1: Yes

Reviewer #2: No

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Reviewer #1: Yes

Reviewer #2: 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: This is a well-written manuscript describing a study evaluating the utility of a mobile phone-based application for promoting HIV pre-exposure prophylaxis (PrEP) uptake among Chinese gay, bisexual and other men who have sex with men (GBMSM).

There are many strengths to the manuscript and the study described within the manuscript.

The app was designed to be culturally appropriate and GBMSM-friendly. Several steps were taken in the development process to ensure relevance to the target audience. First, the initial prototype of the PrEP education mini-app was developed through a Gay-Friendly Doctor Finder Hackathon. Additionally, the app was co-developed with community partners, HIV physicians, and sex education experts to develop the intervention content and user interface design. And early feedback sessions were conducted with GBMSM to test use the app in which participants gave verbal feedback during one-to-one in-depth interviews. The app was then refined based on this qualitative feedback.

Little research has been published on digital health applications with GBMSM in China and thus this study adds a novel contribution to the literature.

The mixed methods design of the randomized trial is a strength and a thorough array of outcome measures were included. Several limitations of the study are clearly stated.

The largest gap in this paper is that the content/tools/functionality of the app itself are not described in any detail in the methods section. Thus, the reader does not fully understand what the app actually does or how participants are advised to use it. The reader actually learns more about components of the app in the discussion section, where some examples of app content are referenced.

Also, the manuscript presents this study as if it is a parallel groups design in which participants are randomly assigned to either the intervention or control intervention; however, the study really is examining the utility of adding the app to standard care (as both groups received the control intervention). This should be presented more clearly in the manuscript.

The abstract should make it clear that no differences across groups were observed in key PrEP outcomes (those seeking consult for PrEP and those filling PrEP prescription). The abstract currently presents these findings collapsed across groups but is silent re: comparisons across conditions.

The rationale for randomizing participants in a 2:1 ratio in the intervention vs. control group is not provided.

The content in the Conclusions section of the abstract appears to overstate the promise of the app, given that the preceding Results section in the abstract does not clearly reflect added benefit of the app.

Overall, although this manuscript is well-written, it is lengthy and could be presented a bit more efficiently.

Reviewer #2: General comments:

From a statistical and study design perspective, this manuscript largely looks good. I had some comments on specific lines and tables of the manuscript that are meant to improve the quality of the manuscript.

I also have a couple general comments. First, you make it clear that this pilot study and I think the presentation and interpretation of the results mostly concurs with this type of design. One piece that you may want to think about is about how you present statistical significance. My feeling here is that the statistical significance does not matter much here given that this study is trying to establish conceptual proof that this intervention could work. Thus, really what is most important is the direction and (potentially) magnitude of the effects. It's clear that this study is underpowered, but that's fully understandable. Therefore the confidence intervals and p-values do not mean as much as they would in a larger study that endeavors to confirm a concept (though I think it's still think it's worthwhile to some to report them).

Second, regarding the magnitude of the effects, I think it would be helpful if you provided some information on how much higher the effects are. For instance, in table 5, for intention to use PrEP, d=0.44 for week 4. What does that 0.44 indicate? Although Cohen's d is a well-accepted measure in the social sciences, it is less well-known in medicine and public health. You might consider comparisons on the raw scale to aid interpretation, but I will leave this up to you. Regardless, I would not short sell the importance of the effect sizes here. Although this is a small study, those effect sizes are important for future research.

Specific comments:

1. (line 72) "rea" should be "area".

2. (Tables 2 and 3) Significance testing between intervention groups is generally frowned upon because a non-significant p-value does not indicate that groups are the same. For info on the topic in relation to baseline imbalance in randomized trials see Altman, https://doi.org/10.2307/2987510 and Senn, https://doi.org/10.1002/sim.4780131703. My recommendation is to remove the significance testing from tables like this and use standardized difference to assess differences (see Austin, https://doi.org/10.1080/03610910902859574).

3. (Table 5) Please mention all these tests (e.g., Wilcoxon, Shapiro-Wilk's) in the statistical methods section.

4. (line 279) I don't know that I would call these "trends" since I don't think changes over multiple time points are being assessed here. Does "differences" work here?

5. (lines 336-338) I think you've stated why you are using Cohen's d in the methods, so I don't feel like you need to restate it here. Maybe if you feel the description in the methods is insufficient, you can move this statement to that section.

6. (p.26, lines 36-39) I suggest cutting the first two sentences of the discussion. These sentences seem to be restating the aims of the study and take away from the main conclusions of the manuscript.

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Reviewer #1: No

Reviewer #2: No

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An instant messaging mobile phone application for promoting HIV pre-exposure prophylaxis uptake among Chinese gay, bisexual and other men who have sex with men: A mixed methods feasibility and piloting randomized controlled trial study

PONE-D-23-10021R1

Dear Dr. Li,

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Sandra Ann Springer, M.D.

Academic Editor

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