Acceptability and feasibility of long-term, real-time electronic adherence monitoring of HIV pre-exposure prophylaxis (PrEP) use among young women in Kenya: A mixed methods study

Vallery A. Ogello; Bernard Kipkoech Rono; Kenneth Ngure; Eric Sedah; Nicholas B. Thuo; Nicholas Musinguzi; Jared M. Baeten; Elizabeth A. Bukusi; Nelly R. Mugo; Jessica E. Haberer

doi:10.1371/journal.pone.0299168

Peer Review History

Original SubmissionSeptember 3, 2022
29 Nov 2023 Decision Letter - Jill Blumenthal, Editor PONE-D-22-24605Acceptability and Feasibility of Long-Term, Real-Time Electronic Adherence Monitoring of HIV Pre-Exposure Prophylaxis (PrEP) Use among Young Women in Kenya: A Mixed Methods StudyPLOS ONE Dear Dr. Rono, 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 address the suggestions made by the reviewers- use your best judgement on what should be changed. Please submit your revised manuscript by Jan 13 2024 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. 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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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: I Don't Know ****** 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 ****** 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: Dear Author, Thank you for this study It is a very good addition to the previous studies/ research on prevention of HIV. This is a highly studious work with excellent originality. Abstract: It is interesting and validly comprises of the right expectation in the body of the study .. Thank you. Introduction: The social and scientific values of the study was apparent, and the expected bridging function was clear Methodology: The study design, setting and procedure follow all the necessary rules for the mixed study. Analysis :Analysis was comprehensive and reasonable. No conflict noticed. The rules guiding the UTATUT in scientific studies were delicately respected. Discussion: The discussions were original and support with the findings in the study I concluded that this is a well conducted study, very relevant and specific. Please find attached : most grammatical errors. Congratulations Reviewer #2: This is a well-written and important paper that adds to the literature around adherence monitoring for PrEP by assessing young people aged 18-24 at high risk of HIV in Kenya. The analysis and results were well laid-out, and use of the Unified Theory Acceptance and Use of Technology (UTAUT) model provided a clear structure for reporting of qualitative results (Fig 1). The quotes are informative and lend valuable insight to the quantitative data. I have some minor suggestions/comments below: - Abstract line 43 is confusing as written "high levels of usefulness interest"; please clarify - Consider merging Tables 2 and 3 (both Acceptability results) so that the data in Table 2 appears as a 4th column in (current) Table 3 (all sites) - You mention in Study Procedures pg 6 that participants in the Intervention arm had the option to switch from daily SMS reminders to reminders triggered by lack of monitor opening. Can you include in Results the proportion of participants who opted to do this? It's an interesting and valuable data point in itself. - Please include a discussion of whether participants could open the bottle but not take the pill, and whether this was assessed as a potential limitation to use of Wisepill devices to accurately measure adherence to PrEP. If this was not addressed at all in this study, please state this as well. ****** 6. 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: Yes: Adeloye Amoo Adeniji Reviewer #2: Yes: Helen Koenig ******** [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.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: PONE-D-22-24605_reviewer.pdf https://doi.org/10.1371/journal.pone.0299168.r001
Revision 1
20 Jan 2024 Author Response Editor’s comments 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. We thank the Editor for the important guidance. We have ensured that the manuscript meets PLOS ONE's style requirements. 2. Please include a complete in your revised copy of PLOS’ questionnaire on inclusivity in global research manuscript. We have included copy of PLOS’ questionnaire on inclusivity in global research. 3. Thank you for stating the following in the Competing Interests section: "I have read the journal's policy and the authors of this manuscript have the following competing; JMB is currently an employee of Gilead Sciences, outside of the present work. JEH reports consultation fees from Merck and stock ownership in Natera. KN has received research funds from Merck (MSD) and speaker fees from Gilead. EAB reports scientific advisory engagement fees and research support from Merck (MSD). The other authors declare no conflicts of interest." Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” We have confirmed that the competing interest does not alter our adherence to all PLOS ONE policies on sharing data and materials and have included the following statement: "This does not alter our adherence to PLOS ONE policy on sharing data and materials.” 4. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. "We have updated the Data Availability statement as follows, but would be happy to see your version if preferable: “The study protocol (including analysis plan), data dictionary, and individual participant data that underlie the quantitative results reported in this Article have been de-identified and posted on the Harvard Dataverse. Because qualitative data cannot be fully de-identified, only the qualitative codebook has been posted on the Harvard Dataverse. Transcript data may be shared through appropriate data use agreements by contacting the Senior Program Manager for Research at the Massachusetts General Hospital Center for Global Health (legarrison@mgh.harvard.edu).” 5. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript. We thank the Editor for this point. We have moved the ethics statement to the method section of the paper. Reviewer #1: Dear Author, Thank you for this study It is a very good addition to the previous studies/ research on prevention of HIV. This is a highly studious work with excellent originality. Abstract: It is interesting and validly comprises of the right expectation in the body of the study. Thank you. Introduction: The social and scientific values of the study was apparent, and the expected bridging function was clear Methodology: The study design, setting and procedure follow all the necessary rules for the mixed study. Analysis: Analysis was comprehensive and reasonable. No conflict noticed. The rules guiding the UTATUT in scientific studies were delicately respected. Discussion: The discussions were original and support with the findings in the study I concluded that this is a well conducted study, very relevant and specific. 1. Please find attached: most grammatical errors. We thank the Reviewer for the positive observations about our study. We have taken note and corrected all grammatical errors in the revised version of the paper. Reviewer #2: This is a well-written and important paper that adds to the literature around adherence monitoring for PrEP by assessing young people aged 18-24 at high risk of HIV in Kenya. The analysis and results were well laid-out, and use of the Unified Theory Acceptance and Use of Technology (UTAUT) model provided a clear structure for reporting of qualitative results (Fig 1). The quotes are informative and lend valuable insight to the quantitative data. I have some minor suggestions/comments below: 1. Abstract line 43 is confusing as written "high levels of usefulness interest"; please clarify We have clarified the sentence to read, “Most participants reported high levels of usefulness and high interest in using the monitor with few problems or worries reported throughout follow-up.” 2. Consider merging Tables 2 and 3 (both Acceptability results) so that the data in Table 2 appears as a 4th column in (current) Table 3 (all sites) Table 2 and Table 3 have been merged as recommended and labelled Table 2. 3. You mention in Study Procedures pg 6 that participants in the Intervention arm had the option to switch from daily SMS reminders to reminders triggered by lack of monitor opening. Can you include in Results the proportion of participants who opted to do this? It's an interesting and valuable data point in itself. We appreciate this suggestion and have added the following statement on line 242, “A total of 24 participants switched from daily SMS reminders to those triggered by lack of monitor openings.” 4. Please include a discussion of whether participants could open the bottle but not take the pill, and whether this was assessed as a potential limitation to use of Wisepill devices to accurately measure adherence to PrEP. If this was not addressed at all in this study, please state this as well. We have revised a statement in discussion, line 530, to read, “The primary limitation of the study is the potential for social desirability bias; the participants’ knowledge that they were being monitored could have triggered device openings that did not correspond to true PrEP adherence (i.e., pill ingestion).” Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0299168.r002
6 Feb 2024 Decision Letter - Jill Blumenthal, Editor Acceptability and Feasibility of Long-Term, Real-Time Electronic Adherence Monitoring of HIV Pre-Exposure Prophylaxis (PrEP) Use among Young Women in Kenya: A Mixed Methods Study PONE-D-22-24605R1 Dear Dr. Rono, 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. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Jill Blumenthal Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0299168.r003
Formally Accepted
26 Feb 2024 Acceptance Letter - Jill Blumenthal, Editor PONE-D-22-24605R1 PLOS ONE Dear Dr. Rono, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Jill Blumenthal Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0299168.r004

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