PONE-D-21-03228

Adaptation and validation of simple tools to screen and monitor for oral PrEP adherence

PLOS ONE

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PLOS ONE

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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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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: The paper touches on an important topic regarding product adherence in clinical trials. The creation of a simple tool that can be used in low resource settings in commendable. The paper however would benefit from a clearer representation of the process undertaken, which could be remedied by a simple schematic to orientate the reader.

Reviewer #2: This is an interesting analysis from Tolley and colleagues. I am not an expert on the validation of psychometric scales so I will focus on contextualization and framing of the findings. In spite of the significant challenges that survey adherence scales have experienced in the field of HIV PrEP--I agree they still play an important role. The paper is well written although I think the methods could use some clarification and some additional attention to contextualizing the findings.

Major point 1: Methods: Please provide additional detail in the methods section about the site, design, and context of the original vaginal ring monitoring tool.

2. Please also clarify the use of the tool for other product types (re: recruitment of product naive participants). What about many women who have not taken a daily pill prior to PrEP? Would this tool still be administered.

3. Intro: You provide a reasonable discussion of the pros and cons of objective vs. self-reported metrics. Is there data that demonstrates that the ring survey correlates with objective adherence? If so I would include it in the introduction or discussion as justification for adapting the scale. Furthermore, ideally this scale would be studied in conjunction with objective adherence metrics as further validation. This will be the major hurdle, given what the field has since learned, in uptake of such a scale.

4. Intro: You mention event-drive PrEP but your scale is not set up to address this delivery strategy nor is it currently indicated in this context so I would remove it. White coat adherence is an issue for short-term adherence markers, cumulative metrics are not impacted.

5. Page 24 line 334. This tool has been presented as a study product monitoring tool, it is not clear to me how it could be used as part of shared decision making between long-acting and other PrEP methods.

6. Page 25 Line 357 and Abstract Conclusions, as no objective adherence metric was included, I don't think you should focus on accuracy during the discussion. I found this confusing when i first read the abstract. I would mention correlation with objective adherence metrics as a next step/limitation

7. Abstract: Need to find space in methods that you adapted the ring tool to measure oral PrEP adherence

Minor

1: Discussion: Page 22 line 306. I am not sure that the relationship between adherence and acceptability is "confounded" by the trial design, although the relationship is more complex and has additional inputs. I would try to reformulate this statement to be more clear

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Reviewer #1: No

Reviewer #2: No

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Attachments

Attachment

Submitted filename: PONE-D-21-03228_reviewer (1).pdf

Adaptation and validation of simple tools to screen and monitor for oral PrEP adherence

PONE-D-21-03228R1

Dear Dr. Tolley,

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,

José das Neves

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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

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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: No

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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 #2: Yes

**********

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: The authors have addressed my concerns adequately. I agree that describing the initial trial would be laborious but some clarification would help the reader. For point 7 from original reviewer 2, I think it would be helpful to state this point not just in the abstract, but also in text, as these should be considered independent products.

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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 #2: No