PONE-D-23-13757Screening for Hypertension in adolescents living with HIV: protocol for a cluster randomized trial to improve guideline adherencePLOS ONE

 

Dear Dr. Adu-Gyamfi,

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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ACADEMIC EDITOR: After a careful evaluation of your manuscript and the review comments, you are required to address the issues raised by the reviewers and re-submit your revised manuscript. You can disregard reviewer # 1 comment on lines 31, 86 and 87 asking if the study is already done or yet to be done.

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Please submit your revised manuscript by Aug 10 2023 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.

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Academic Editor

PLOS ONE

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Additional Editor Comments:

You are invited to address the comments raised by the reviewers and re-submit your revised manuscript.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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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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

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Review Comments:

Abstract

Line 52; ‘them’ refers to what exactly

Introduction

Iine 78, seems to indicate available evidences to your study, why doing it.

Methods

Line 31,86 and 87 ; Is the study already done or yet to be done. In either case check your language in the entire manuscript.

Inclusion criteria must be properly be stated to capture age group above 18 years. What happens to facilities that provide the antiretroviral drugs services? What kind of qualification is accepted?

Line 104&105, Why not added to inclusion criteria section.

What is the difference between setting & recruitment and inclusion & exclusion criteria since the contents are similar.

Line 110 to 112, 114 and 115; the language seems more of proposal rather than article for publication.

Line 124; how did you come by 10, 80 and 400?

What type of blinding was done?

Line 166; Yet to be followed or had been followed?

Line 180 & 189, was the data extracted from client records or questionnaire was used? Needs clarification.

What becomes of the data after the study?

What is new about this study

Reviewer #2: This is the description of the protocol of an important multi-facility cluster-randomized study which will be conducted in 20 antiretroviral therapy sites in the Greater Accra Region of Ghana in which adolescent living with HIV are routinely seen for care. The protocol is very well written and includes detailed descriptions of randomisation, concealment of allocation, blinding and statistical procedures as requested by the CONSORT statement. The study if completed is likely to provide evidence to guide health system strengthening efforts towards targeting missing opportunities for monitoring of hypertension and preventing cardiovascular disease in adolescents living with HIV. I support the publication of trial protocols as a tool to increase reproducibility in medical research.

I only have minor comments:

Line 103. 28% of the adolescents living with HIV in Ghana receive care in this Region does not seem to be ‘Most’ of them.

Lines 178-185. I assume this will be done at each 20 facilities to achieve the target sample size of 20 x 20 = 400 adolescents. It is unclear from reading the text.

Line 192. The fact that the principal investigator will have access to the data is an anomaly. I suggest that especially the PI is kept blind to the data as the knowledge of interim data could affect the conduct of the trial.

Line 198. I would avoid square root transformations as it is cumbersome to transform back to the original scale. Use non-parametric tests on the natural scale instead.

Line 208. If a logistic regression is used it should be Odds Ratios or Risk Ratios, not Rate Ratios

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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

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Screening for Hypertension in adolescents living with HIV: protocol for a cluster randomized trial to improve guideline adherence

PONE-D-23-13757R1

Dear Dr. Adu-Gyamfi,

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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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,

Miquel Vall-llosera Camps

Staff Editor

PLOS ONE

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #3: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #3: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #3: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 #3: 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 #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #3: The authors adequately addressed all the previous comments raised by the reviewers. I have no more comments to add.

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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 #3: No

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