PONE-D-23-37288Effectiveness of Interactive Voice Response-Call for life mHealth tool on adherence to Anti-Retroviral Therapy among young people living with HIV: A randomized trial in UgandaPLOS ONE

Dear Dr. Bwanika Naggirinya,

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.

==============================Editor's comments Bwanika et al

Please follow the journal formats and be concise

Be very clear with the sample size determination: You have two outcomes (viral load suppression and retention). You state the difference between arms though not showing whether on viral load or retention! How are both outcomes taken care of in the sample size estimation?

Have a clear section on randomization concealment.

Line 167/168 talks of a final model! what was in this model and how was it estimated?

Please note that the write-up should at all times compare between arms.

Why include p-values in the baseline table? what do they mean? please check on how to report the baseline table of randomized controlled trials.

Please submit your revised manuscript by Mar 08 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. 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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Andrew Max Abaasa, Ph.D.

Academic Editor

PLOS ONE

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Reviewers' comments:

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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: No

Reviewer #2: Yes

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

Reviewer #1: No

Reviewer #2: Yes

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Reviewer #1: No

Reviewer #2: Yes

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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: No

Reviewer #2: Yes

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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: General comments:

This manuscript reports the results for a trial of an mHealth intervention for young people living with HIV.

Overall, I believe this manuscript has some merit, but I have some concerns about the analyses, design, and reporting.

Regarding the analyses, there is no information in the statistical methods section about which statistical methods were used. This is important for determining how significance testing was done, confidence intervals were calculated, and whether anything was done to assess differences between study characteristics. The latter is very important since Tables 3 and 4 suggest there might be potential confounders, i.e., other explanations for the differences that are found. Best I can tell, no multivariable analyses have been performed and I think the manuscript would benefit from those, even if they come to the same conclusion as the current analyses.

I also feel as though not having full baseline virology data is problematic. Not having the baseline data means it is not possible to know the changes in suppression from baseline to endline. It could be that the intervention group had a greater percentage of people with suppressed viral loads at baseline and, hence, were at greater likelihood of having a suppressed viral load at endline. I'm not sure how to rectify this, but this seems like a major problem to me.

Finally, PLOS ONE does not copyedit manuscripts and, as stated in publication criterion #5 (https://journals.plos.org/plosone/s/criteria-for-publication#loc-5), can reject manuscripts without clear descriptions. There are some incomplete sentences and strange capitalization throughout. Some parts feel almost pasted in. All of this will need to be rectified and greater care taken with the exposition.

Furthermore, the introduction could be shortened. I think the first and last paragraphs are good, but the middle is too detailed. I suggest condensing this part down into a couple paragraphs by either making only the most salient points or by summarizing the points made in as few words as possible and letting the references do the describing.

Finally, I thought the subsections (e.g., "Standard of Care (Usual Care) Arm") were useful, though one is not needed for every paragraph. I would trim down the use of these somewhat and then convert the remaining to subsection headers on their own lines and in italics as opposed to how they are in the text right now.

Specific comments:

1. (line 17) I didn't understand the clause "month 6 and 12".

2. (lines 94-98) I don't think "Health" and "Hospital" should be capitalized when they are not part of a proper noun.

3. (line 108) Please describe the algorithm or program that was used to randomize the order of the envelopes.

4. (line 132) I don't believe "Intervention" should be capitalized.

5. (lines 138-139) There should be an ethics section of the manuscript that includes IRB and trial registration as well as full information on how consent and assent were collected.

6. (lines 143-144) Again, a strange sentence when describing the month 6 and month 12 visits.

7. (lines 147-152) These two sentences are both incomplete. Plus, the openepi.com reference should be included in the bibliography and, again, strange capitalization. I suggest writing these as complete sentences and not just dumping output in the manuscript.

8. (lines 158-159) Run-on sentence. I think this sentence is supposed to define ITT but it does not.

9. (lines 165, 167) Why are you using different definitions of statistically significant?

10. (line 186, table 1) Significance testing between intervention groups is generally frowned upon because a non-significant p-value does not indicate that groups are the same. For info on the topic in relation to baseline imbalance in randomized trials see Altman, https://doi.org/10.2307/2987510 and Senn, https://doi.org/10.1002/sim.4780131703. My usual recommendation is to remove the significance testing from tables like this and use standardized mean differences (SMD) to assess imbalance (see Austin, https://doi.org/10.1080/03610910902859574). Most often, I see authors using an SMD of 0.1 or 0.2 as a threshold for assessing imbalance, though this could vary by field.

11. (lines 230-239) I believe this should be in the discussion section and not the results section.

Reviewer #2: The manuscript carries an important message in good English and is a result of a well conducted RCT. However it needs to edited to bring into a good standard for publication. The authors need to adhere to standard structure of the journal and ensure that tables are standalone with adequate description. Importantly they need to tailor the introduction to relevant information only. If the edits suggested are implemented, I think the manuscript will be of a good enough standard for publication.

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Reviewer #1: No

Reviewer #2: No

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Attachments

Attachment

Submitted filename: Review Comments -PLOS1-pdf.pdf

PONE-D-23-37288R1Effectiveness of Interactive Voice Response-Call for life mHealth tool on adherence to Anti-Retroviral Therapy among young people living with HIV: A randomized trial in UgandaPLOS ONE

Dear Dr. Bwanika Naggirinya,

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 Jun 07 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. 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,

Andrew Max Abaasa, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments:

You have fairly responded to the issued raised by the editor and reviewers. Further revisions include;

(1) Please go through your manuscript sentence by sentence and improve on the language

(2) Why was Kiryandongo picked as the study district? Why those particular health centres? How were they selected from the many health centres in the district?

(3) How and where was viral load (VL) testing done from? please have a section on viral loading testing.

(4) Under ethics, what care was provided to participants with unsuppressed VL?

(5) Be specific with your outcomes; in the outcomes section, you define primary and secondary outcomes. However, in the statistical analysis, other outcomes such as VL at month 6 crop up. Please state all outcomes under the outcomes section distinguishing between primary and secondary outcomes.

(6) You need a convincing justification why you choose Per Protocol over Intention to Treat analysis

(7) I know SMD had been suggested by a reviewer, however, you do not need to show statistical differences on baseline table characteristics for a randomized controlled trial. Only use this table for intended observation on randomization and decide as necessary.

(8) Table 1 footnote, *only 75 participants had baseline VL, Statistical methods: sensitivity analysis was performed adjusting for baseline VL. How were missing VL handled. Besides the table shows more numbers with baseline VL when broken down by trial arm!

(9) Conclusion; you emphasize adherence and retention and no mention of viral suppression? While adherence and VL are linked, one isn’t a direct substitute for the other.

(10) What do you recommend from your trial

[Note: HTML markup is below. Please do not edit.]

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Effectiveness of Interactive Voice Response-Call for life mHealth tool on adherence to Anti-Retroviral Therapy among young people living with HIV: A randomized trial in Uganda

PONE-D-23-37288R2

Dear Dr. Naggirinya

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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Andrew Max Abaasa, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: