Advancing data to care strategies for persons with HIV using an innovative reconciliation process

Merceditas Villanueva; Janet Miceli; Suzanne Speers; Lisa Nichols; Constance Carroll; Heidi Jenkins; Frederick Altice

doi:10.1371/journal.pone.0267903

Peer Review History

Original SubmissionAugust 24, 2021
21 Feb 2022 Decision Letter - Sungwoo Lim, Editor PONE-D-21-27478Advancing data to care strategies for persons with HIV using an innovative reconciliation processPLOS ONE Dear Dr. Villanueva, 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 Apr 07 2022 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: https://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, Sungwoo Lim, DrPH Academic Editor PLOS ONE Journal requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/fileid=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf". 2. Please update your submission to use the PLOS LaTeX template. The template and more information on our requirements for LaTeX submissions can be found at http://journals.plos.org/plosone/s/latex. 3. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide. 4. Please include your full ethics statement in the ‘Methods’ section of your manuscript file. In your statement, please include the full name of the IRB or ethics committee who approved or waived your study, as well as whether or not you obtained informed written or verbal consent. If consent was waived for your study, please include this information in your statement as well. [Note: HTML markup is below. Please do not edit.] 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: Partly ******** 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: This is an excellent manuscript that meets all of the criteria for publication in PLOS ONE. I think it is an important and interesting contribution to the literature. It addresses an important topic, the methods are well described, the results are clear, and the conclusions are sound and based on the data presented. Thank you for the opportunity to review this excellent paper! Reviewer #2: The issue of out of care is certainly of paramount importance in efforts to end the HIV epidemic in the United States and globally. The authors are commended for their work in this area. Figure 1 and accompanying text: The reference to boxes was quite vexing as there were not separate boxes but lines in the same box for Boxes B-D and Box A was not labeled as Box A. This needs clarification as it took me some time to sort out this issue. One piece of information that I did not find included and is critical to understand weigh the validity of the conclusions is the timeframe for the "Well Patient"- two negative viral loads at least 6 months apart. From my reading of the paper, the last two available viral loads would be used for this measure. How long ago was that? I think it would be helpful to have the range and median available for the viral load measure throughout the paper (in the text or tables) for the reader to guage the recency of those values. The authors use relatively old CDC estimates for out of care. Is that because that estimate correlates with the timing of the study? If so, please clarify in the text. There appears to be a typographical error in page 4, paragraph 4, line 8 "Formuse of HD staff" ****** 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: No Reviewer #2: 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.] 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. https://doi.org/10.1371/journal.pone.0267903.r001
Revision 1
5 Apr 2022 Author Response Dear editors: We thank the reviewers for their comments on our manuscript. Specific responses to individual comments are detailed below: Reviewer #1: This is an excellent manuscript that meets all of the criteria for publication in PLOS ONE. I think it is an important and interesting contribution to the literature. It addresses an important topic, the methods are well described, the results are clear, and the conclusions are sound and based on the data presented. Thank you for the opportunity to review this excellent paper! We thank the reviewer for endorsing the importance of our study. Reviewer #2: The issue of out of care is certainly of paramount importance in efforts to end the HIV epidemic in the United States and globally. The authors are commended for their work in this area. We thank the reviewer for this comment. Figure 1 and accompanying text: The reference to boxes was quite vexing as there were not separate boxes but lines in the same box for Boxes B-D and Box A was not labeled as Box A. This needs clarification as it took me some time to sort out this issue. Thank you for requesting this clarification. We have revised Figure 1. Flowchart for Enrollment of Patients Who Disengage from Medical Care to specifically delineate Box A and also to separate out Boxes B, C, D. One piece of information that I did not find included and is critical to understand weigh the validity of the conclusions is the timeframe for the "Well Patient"- two negative viral loads at least 6 months apart. From my reading of the paper, the last two available viral loads would be used for this measure. How long ago was that? I think it would be helpful to have the range and median available for the viral load measure throughout the paper (in the text or tables) for the reader to guage the recency of those values. Thanks for this clarification as the recency of VL testing is important to assessing clinical status. In the Methods section, we added details to specify that the designation of “Well Patient” required that at the time of case conference (encompassing the prior 18 months which included the 12 month “in care” period and a 6 month “out of care” period), there were 2 VLs at least 6 months apart that were <20 copies/ml AND there were no detectable VLs during the in-care period. So all “Well Patients” had relevant test results within at most an 18 month timeframe. Most “Well Patients” had available VL results within the prior 6-12 months. The authors use relatively old CDC estimates for out of care. Is that because that estimate correlates with the timing of the study? If so, please clarify in the text. We appreciate this comment. We originally quoted the older CDC estimates of out-of-care from 2016 which estimated that 49% of PWH are retained in care and 53% are virally suppressed. Our study was conducted from 11/2016-7/2018 which partially encompasses the earlier timeframe. However, we acknowledge that there were improvements in 2018 CDC estimates showing that 58% of PWH were retained in care and 65% were virally suppressed. We have modified the abstract and introduction to cite these improved estimates. There appears to be a typographical error in page 4, paragraph 4, line 8 "Formuse of HD staff" This typographical error has been corrected and now reads “use of HD staff to review surveillance records...” Additional revisions: Additional edits to the Methods section were made to include a full ethics statement. Re: Data Availability: All our data are-de-identified and open access. Anyone who wants to review the data can provide a data request to receive data for analysis after it has been reviewed by our publication committee. We look forward to your consideration of our revised manuscript. Sincerely, Merceditas S. Villanueva, MD https://doi.org/10.1371/journal.pone.0267903.r002
19 Apr 2022 Decision Letter - Sungwoo Lim, Editor Advancing data to care strategies for persons with HIV using an innovative reconciliation process PONE-D-21-27478R1 Dear Dr. Villanueva, 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, Sungwoo Lim, DrPH Academic Editor PLOS ONE 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: All comments have been addressed ******** 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 ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes 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 #1: Yes 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 #1: Yes 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 #1: The authors have satisfactorily addressed all reviewer comments. The manuscript meets all criteria for publication in PLoS ONE. Reviewer #2: All my comments have been addressed. This is an excellent paper and will be instructive as states work engage patients with HIV who are out of care. ****** 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 https://doi.org/10.1371/journal.pone.0267903.r003
Formally Accepted
25 Apr 2022 Acceptance Letter - Sungwoo Lim, Editor PONE-D-21-27478R1 Advancing data to care strategies for persons with HIV using an innovative reconciliation process Dear Dr. Villanueva: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. 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 plosone@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. Sungwoo Lim Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0267903.r004

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .