Peer Review History

Original SubmissionSeptember 25, 2023
Decision Letter - Lynn S Zijenah, Editor

PONE-D-23-29770Implementation of the advanced HIV disease care package with point-of-care CD4 testing during tuberculosis case finding: a mixed-methods evaluation.PLOS ONE

Dear Gils,

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 Dec 07 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.to enhance the reproducibility of your results. Protocols,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. 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,

Lynn S Zijenah, PhD

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/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. 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.

3. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments:

Under "Data Availability" the Authors stated "No - some restrictions will apply". Authors please elaborate the restrictions.

[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: Yes

********** 

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

********** 

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 feasibility study on the implementation of Advanced HIV disease care package on 1392 PLHIV was very well conducted. The outcome of this study will be useful for the country programs when AHD is getting implemented.

Reviewer #2: In this implementation science study, Gils et al implement the AHD package of care into a TB case finding setting.

Overall this study is well conducted and well explained.

1. I would recommend the authors add further detail regarding the characteristics of the clinic and laboratories that wer e included in this study.

Study setting is only briefly mentioned in lines 93-94.

Please clarify what a "container-based clinic" refers to. And what is meant by a 'mobile unit' (line 94).

What types of clinics were these. On average how many patients are seen per day/week/year. What type of laboratory did they have. How many lab staff were available, and what other types of tests were being performed at the same time? This will help us to better understand implementation of the AHD package of care in context.

Are these busy, high volume clinics/labs that run many other tests? Or are these rural, low volume sites where they have a dedicated lab worker to run the Visitect test?

2. I strongly suspect that you have inaccurate Visitect results (meaning that there are many people with CD4>200 who were misclassified as having a CD4<200), as the authors have suggested in the Discussion. Which would explain high survival (low mortality) among the population with AHD.

As such, I would recommend softening your conclusions (in the paper and in the abstract), accounting for this critical limitation. Specifically in lines 47-48: "AHD nor TB were associated with survival suggesting adequate management referral". I think the lack of association with reduced survival suggests false positive Visitect results contaminating your AHD population. I would add that to your abstract. I find the wording of lines 47-48 to be confusing, with the word "nor" but "neither".

I think the issue of inaccurate Visitect results is so important in accounting for any conclusions, I would include it at the end of the first paragraph of your Discussion. Without that context, people might conclude that people with AHD have good survival and there's really no reason to perform additional interventions/dedicate additional resources here. Which I believe is incorrect.

Minor point:

The Tables appear to be mislabeled. Two tables are labeled as 'Table 2'.

********** 

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.

Revision 1

Dear Dr. Zijenah, reviewers,

Thank you for reviewing our manuscript. We hereby submit our point-by-point rebuttal to your comments. The line numbers in our responses reflect those in the tracked version. We think your suggestions have led to an improved manuscript and we hope you find the revised version suitable for publication.

On behalf of all authors,

Tinne Gils

Researcher HIV&TB

Department of Clinical Sciences

Tel: +32/490399978

tgils@itg.be / www.itg.be

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/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. 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.

Response: We have added the DOI with access to the dataset: https://figshare.com/articles/dataset/dataset_plhiv/24434668.

3. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Response: We have revised and corrected the reference list.

Additional Editor Comments:

Under "Data Availability" the Authors stated "No - some restrictions will apply". Authors please elaborate the restrictions.

Response: No restrictions apply. We have corrected the statement.

Reviewer #1: This feasibility study on the implementation of Advanced HIV disease care package on 1392 PLHIV was very well conducted. The outcome of this study will be useful for the country programs when AHD is getting implemented.

Reviewer #2: In this implementation science study, Gils et al implement the AHD package of care into a TB case finding setting.

Overall this study is well conducted and well explained.

1. I would recommend the authors add further detail regarding the characteristics of the clinic and laboratories that wer e included in this study.

Study setting is only briefly mentioned in lines 93-94.

Please clarify what a "container-based clinic" refers to. And what is meant by a 'mobile unit' (line 94).

What types of clinics were these. On average how many patients are seen per day/week/year. What type of laboratory did they have. How many lab staff were available, and what other types of tests were being performed at the same time? This will help us to better understand implementation of the AHD package of care in context.

Are these busy, high volume clinics/labs that run many other tests? Or are these rural, low volume sites where they have a dedicated lab worker to run the Visitect test?

Response: The clinics were specifically placed for the conduct of the TB TRIAGE+ trial, and all interventions described in the study procedures were performed there. We have extensively adapted the setting and intervention to answer to your questions. Additional information is provided in lines 98-103 and 131-138.

2. I strongly suspect that you have inaccurate Visitect results (meaning that there are many people with CD4>200 who were misclassified as having a CD4<200), as the authors have suggested in the Discussion. Which would explain high survival (low mortality) among the population with AHD.

As such, I would recommend softening your conclusions (in the paper and in the abstract), accounting for this critical limitation. Specifically in lines 47-48: "AHD nor TB were associated with survival suggesting adequate management referral". I think the lack of association with reduced survival suggests false positive Visitect results contaminating your AHD population. I would add that to your abstract. I find the wording of lines 47-48 to be confusing, with the word "nor" but "neither".

I think the issue of inaccurate Visitect results is so important in accounting for any conclusions, I would include it at the end of the first paragraph of your Discussion. Without that context, people might conclude that people with AHD have good survival and there's really no reason to perform additional interventions/dedicate additional resources here. Which I believe is incorrect.

Response: Indeed, after consultation with the co-authors we agree with the importance of the low accuracy of VISITECT, and we have reflected this in the abstract (lines 50-51), discussion (lines 376-377 and lines 482-485), and conclusion (lines 507-8).

Minor point:

The Tables appear to be mislabeled. Two tables are labeled as 'Table 2'.

Response: This has been corrected.

Attachments
Attachment
Submitted filename: Response to Reviewers.docx
Decision Letter - Lynn S Zijenah, Editor

Implementation of the advanced HIV disease care package with point-of-care CD4 testing during tuberculosis case finding: a mixed-methods evaluation.

PONE-D-23-29770R1

Dear Dr. Gils Tinne,

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,

Lynn S Zijenah, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Formally Accepted
Acceptance Letter - Lynn S Zijenah, Editor

PONE-D-23-29770R1

PLOS ONE

Dear Dr. Gils,

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

Professor Lynn S Zijenah

Academic Editor

PLOS ONE

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 .