PONE-D-22-23739Biopsychosocial approach to understanding predictors of depressive symptoms among men who have sex with men living with HIV in Selangor, Malaysia: A mixed-methods study protocolPLOS ONE

Dear Dr. Abdul Manaf,

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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Jamie Males

Editorial Office

PLOS ONE

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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: Partly

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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: Partly

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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

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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

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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

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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: ABSTRACT

- Abstract should be clearer in objectives that this is only a published protocol and not the results from the study that will be conducted in the future

- Add “%” to depression prevalence estimates

BACKGROUND

- Is the prevalence for depression (43% t 51%) for a region, country or globally?

- Page 4, define ART as it appears for first time

- Replace HIV-positive individual with “individuals living with HIV”

- Recommend adding more background statistics like the size of the study population in Malaysia to demonstrate public health impact. Can also give the proportions of Malay MSM compared to other Malay people living with HIV.

- Is there any theoretical framework being used to generate the research questions and also to help guide instrument development for both phases of research?

METHODS

- Pg. 7, end of bullet 3, missing word “factors” at the end of the statement

- Last sentence on page seven written in past tense so there is tense discord

- Pg 8, should it be philosophy framework?

- Pg 8, what if all the sample or most of the sample in the quantitative phase has moderate or sever depression, how will the 20 participants for the qualitative phase be selected?

- Pg. 9/10 – are there eligibility criteria related to HIV status?

- Pg. 10, is the questionnaire computer administered or otherwise?

- Will an interview guide be developed for the in-depth interviews

- Logistic regression is proposed for analysis, are all the outcome variables dichotomous?

- Is there any plan for missing variables or outliers?

- Recommend having more than one coder for the qualitative data analysis

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Reviewer #1: No

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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.

PONE-D-22-23739R1Biopsychosocial approach to understanding predictors of depressive symptoms among men who have sex with men living with HIV in Selangor, Malaysia: A mixed-methods study protocolPLOS ONE

Dear Dr. Abdul Manaf,

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 take note that you need to address the reviewer's comments accordingly to strengthen the quality of your protocol. 

Please submit your revised manuscript by May 27 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.

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,

Rogie Royce Carandang, RPh, MPH, MSc, PhD

Academic Editor

PLOS ONE

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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 #2: Partly

**********

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 #2: Partly

**********

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 #2: No

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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 #2: No

**********

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 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 #2: Overview

The authors present a robust study protocol of a mixed-methods study that follows an explanatory-sequential design to understand factors associated with depressive symptoms among Malaysian MSM living with HIV. I commend the researchers for dedicating their time and resources to an underservices and under-engaged population. Although an important topic, there are major issues with this manuscript concerning a) the framing of the study, b) the methods (e.g.,: sample size calculation, unclear inclusion criteria and setting description), and c) the discussion. Most importantly, attention is not paid to how the data will be integrated, and this is core to a mixed-methods study. I have outlined specific concerns below.

Abstract

1. The background could use further attention to the socioecological factors mentioned that affect people living with HIV. It isn’t enough to state that these factors exist – how do they related specifically to the psychological wellbeing of people living with HIV?

Introduction

1. The first paragraph would greatly benefit from varied sentence structure so that most sentences do not begin with “Depression”.

2. MSM should be defined prior to use of the abbreviation, as should HIV.

3. You should state the prevalence of depression among MSM to further make the point that depression prevalence is elevated among MSM with HIV.

4. “MSM is likely to be the main key population in Malaysia by 2030.” I don’t think this says what you mean for it to say. Do you mean that “By 2030, MSM are projected to account for the largest share of prevalent HIV infections in Malaysia”

5. You do not sufficiently set up how “mental health information from MSM living with HIV” will be used. What value does this information bring? Does it inform interventions?

6. Respectfully, I do not follow the decision to end the introduction by saying that this work will identify gaps in health services. You set up the protocol by wanting to understand factors that are associated with depression among MSM, and then discuss how this is of relevance because depression has been associated with non-adherence to HIV medications and other sexually risky behaviors. I would just make it clear that you’re focused on individual determinants of behavior – your data is not going to speak to gaps in health services because, from what I can tell, you are not proposing to assess these factors.

Methods

1. I am alarmed at the last sentence of the first paragraph in the methods: “The respondents will be given access to personal information… upon request”. Please clarify the meaning of this.

2. The authors explain the phases and rationale for such phases, of their mixed-method design, well. Yet no attention is paid to data integration.

3. I do not follow the sample size justification. A sample size of nearly 1000 MSM with HIV to recruit in a period of approximately 4 months, even across 10 sites with an established sampling frame, seems improbable. Might you be able to speak to the feasibility of this based on past work by your team and or additional information about the recruitment sites? I also do not understand why the sample size calculation is not grounded in your statistical approaches.

4. If you are interested in an outcome of depression, why are you not screening participants to enroll those with clinically significant depressive symptoms? There is no guarantee that you will result in a sample of MSM with HIV who also have depression that is large enough to facilitate your analysis

5. Inclusion criteria – “Men identified as homosexual based on clinic database”. This will exclude MSM who are not homosexual. MSM is a behavior, not an identity.

6. It seems that site selection is conflated with participant selection. For example – criterion 4 is that there must be more than 200 MSM with HIV. This isn’t a participant level factor.

7. No where does it say that the participants must have HIV in the inclusion criteria

8. Section 4 social support. PLHIV is used and not defined

9. Might you consider measuring other likely relevant constructs including: self-efficacy in adhering to medications, internalized MSM related stigma

10. It is not clear how random sampling will occur.

11. It is not clear why you would need to do a pilot study with 30 people to look for internal consistency of the select items. Have these measures not performed well in other samples? I could see you wanting to pilot if you were creating original measures.

12. The section on the ethical reasons of linking people who screen with depression to care should be included prior to the section on analysis.

13. You have not written about exploring the nature of the missing data nor considered imputation to address missingness, which you could do with a sample size as large as you have.

14. With a proposed sample size as large as you have and for a research question like you pose, it is a missed opportunity to not engage in structural equation modeling. You’re really interested in a lot of latent variables that are challenging to conceptualize and measure that affect the experience of depression in an individual who is MSM and also HIV+

15. Despite this being a mixed methods study, no attention is paid to the integration of the data.

Discussion

1. I find it problematic to describe recall measures as buffering against the limitation of cross-sectional data. The data is still cross-sectional in nature. Perhaps instead of stating this, you could reiterate the value of the cross-sectional data (point prevalence of depression among a large sample of MSM is very useful, understanding of factors associated with depression informs intervention, or identifying factors that are protective against depression is useful too!)

2. Overall – it is less important to be discussing how withdrawal of participants will be handled. I would save that for unpublished material. What would be most informative is a discussion of how this data will be integrated (quant/qual mixing), reiteration of the relevance of this work. ETC.

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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

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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.

PONE-D-22-23739R2Biopsychosocial approach to understanding predictors of depressive symptoms among men who have sex with men living with HIV in Selangor, Malaysia: A mixed methods study protocolPLOS ONE

Dear Dr. Abdul Manaf,

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 see the attached file for my minor comments. 

Please submit your revised manuscript by Jun 18 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.

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,

Rogie Royce Carandang, RPh, MPH, MSc, PhD

Academic Editor

PLOS ONE

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[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-22-23739_R2.docx

Biopsychosocial approach to understanding predictors of depressive symptoms among men who have sex with men living with HIV in Selangor, Malaysia: A mixed methods study protocol

PONE-D-22-23739R3

Dear Dr. Abdul Manaf,

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.

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Kind regards,

Rogie Royce Carandang, RPh, MPH, MSc, PhD

Academic Editor

PLOS ONE