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"Picking the right person ... can make or break the whole deal": Development of a layperson injector selection tool for administration of home-based long-acting injectable antiretroviral therapies

PLOS One

Dear Dr. Bourdeau,

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Kind regards,

Omar Sued, MD, PhD

Academic Editor

PLOS One

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[This work was supported by the Centers for Disease Control and Prevention (CDC),

U.S. Department of Health and Human Services (HHS), under grant number

5U01PS005259 awarded to PS. The funder's website is: https://www.cdc.gov.

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Additional Editor Comments:

Dear Dr. Bourdeau and colleagues,

Thank you for submitting your manuscript entitled “‘Picking the right person … can make or break the whole deal’: Development of a layperson injector selection tool for administration of home-based long-acting injectable antiretroviral therapies” to PLOS ONE, and for your patience during the review process.

After careful consideration of the manuscript and the two external peer reviews, I am writing to inform you that the editorial decision is Major Revision.

Both reviewers found the study to be well conducted, methodologically sound, and highly relevant to the implementation of long-acting injectable ART, and they recognized the importance of the topic and the strength of the stakeholder-engaged, multi-phase tool development process. However, both reviewers also raised substantive concerns that must be addressed before the manuscript can be considered for publication. These issues primarily relate to clarity, transparency, and interpretation, rather than the overall validity of the work.

Rationale for Major Revision

Although Reviewer 2 characterizes the required changes as “minor,” the reviewers’ collective comments indicate the need for substantial clarification and restructuring across multiple sections of the manuscript, particularly regarding:

The methods and analytic framing

The purpose, scoring, and interpretation of the selection tool

The practical and clinical application of results

The limitations and generalizability of the findings

Addressing these points will require careful revision of the Methods, Results, and Discussion sections, as well as improved alignment across sections. For this reason, a Major Revision decision is appropriate.

Key Areas Requiring Revision

In preparing your revision, please pay particular attention to the following areas, which were raised by both reviewers, sometimes from different perspectives:

1) Clarification of Tool Purpose, Scoring, and Interpretation

Clearly describe how the tool is intended to be used by people with HIV in practice.

Explicitly explain how Likert-scale items are scored, whether items are summed or interpreted individually, and whether any cut-points, thresholds, or decision rules are implied.

Clarify what constitutes a “suitable” versus “unsuitable” treatment buddy and how scores should inform patient–clinician discussion and counseling.

2) Methods Transparency and Consistency

Provide additional detail on the development of interview guides, including example questions (ideally in a table or Supplement).

Clarify the role and consent of treatment buddies, particularly in the pilot phase, to avoid confusion regarding who used the tool and for what purpose.

Address inconsistencies or ambiguities in the study timeline (e.g., interview and pilot phases).

More clearly describe the Community Advisory Panel (CAP), including its function, sampling strategy, and how it differs from cognitive interviewing.

3) Dyadic Framing and Terminology

Reviewer 1 raised concerns about the use of “dyads” without corresponding dyadic analysis, while Reviewer 2 encouraged stronger linkage to dyadic literature.

To resolve this tension, we suggest that you:

Avoid implying dyadic analysis if none was conducted; and

Retain discussion of dyadic concepts at a conceptual or theoretical level in the Discussion, with appropriate caveats.

4) Results Presentation and Ceiling Effects

Expand discussion of pilot results where ceiling effects were observed, including implications for interpretation, tool sensitivity, and future validation.

Consider whether scoring or item distributions should be more explicitly contextualized in the Results and Discussion.

5) Discussion and Limitations

-Strengthen the Discussion by explicitly addressing:

Differences and similarities across clinician, patient, and TBY perspectives;

Cultural, relational, and contextual considerations in TBY selection;

The small pilot sample size and urban study setting;

Planned next steps for validation, including reliability and internal consistency testing.

-Ensure strengths and limitations are clearly delineated and appropriately placed within the Discussion.

6) Manuscript Organization and Redundancy

Consolidate repetitive sections in the Introduction, particularly overlapping background paragraphs.

Consider whether figures or tables (e.g., Figure 1) add substantive value or could be replaced with content more directly supporting methodological clarity.

7) Reviewer Tensions

We note some differences in emphasis between the two reviews (e.g., degree of revision required, dyadic framing). These are not contradictory but reflect different perspectives. You are not expected to “choose” between reviewers; rather, please address the underlying concern raised by each, clearly explaining how revisions resolve them. Where you decide not to implement a suggestion, please provide a concise justification in your response letter.

Please submit:

A revised manuscript with tracked changes or clearly indicated revisions; and

A detailed, point-by-point response to each reviewer comment.

For your convenience, both reviewer reports are appended below.

We appreciate the importance and promise of this work and encourage you to revise and resubmit. We look forward to reviewing a revised version that addresses the issues raised and strengthens the manuscript’s clarity, interpretability, and applicability.

Sincerely,

Omar Sued

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

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Reviewer #1: Yes

Reviewer #2: Yes

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

Reviewer #1: Yes

Reviewer #2: N/A

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

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-->5. Review Comments to the Author

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Reviewer #1: Overall thoughts: This is a well-conducted, methodologically sound study addressing an important gap in LAI-ART implementation. The multi-phase, stakeholder-engaged tool development process is exemplary, and findings have direct practical implications for expanding home-based HIV care. With making minor revisions detailed here, this manuscript will make a strong contribution to PLOS ONE.

Major issues:

• Authors should be more explicit in their discussion of limitations of the study and comment on the small sample size of this pilot (n=7) in addition to the fact that all participants are from urban settings (San Francisco Bay Area clinics), as this may affect real world performance

• Furthermore, authors are encouraged to include preliminary internal consistency measures from the pilot data and outline validation plans for future work to address the lack of reliability analysis from the study.

• Even though the study generates important data on the subject, information on contextualizing results is missing. Authors should include a section on interpretation of scores and clinical application of results i.e., what exactly does ‘suitable’ or ‘unsuitable’ TBY denote? How should clinicians apply the scores as part of counselling?

Minor issues:

• Authors state that semi-structured interviews were conducted between June 2024 and April 2025 (lines 103-105), and pilot testing (phase 3, line 136-137) from June to September 2025? Kindly align timeline

• Kindly clarify the sampling strategy employed in phase 4 (Community Advisory Panel) and report participation rate

• Further discussion is required for all scores greater or equal to 3 under the ceiling effects under the results section

• Phase 2: Drafting the Tool (results, lines 232-249) could be clearer if presented in chronological order, consider revising.

• Kindly specify the ‘missing’ on Table 1, is it clinicians or TBY?

• Although the discussion is well-written, it can be further enhanced by addressing cultural considerations in TBY selection and strengthening parallels to dyadic HIV/health literature with specific examples

• Lines 40-51 and 53-63 appear repetitive, consider consolidating.

Reviewer #2: Thank you for the opportunity to review this manuscript on the development of a treatment buddy (TBY) selection tool for patients receiving long-acting injectable antiretroviral therapy (LAI-ART). This manuscript addresses access, confidentiality and comfort around treatment options for PLWHA, with the goal of having more PLWHA with undetectable status'. While this manuscript adds to the literature about LAI-ART and alternative delivery models, there are several areas of concern which I detail below:

Major:

Introduction --

lines 53-63 --- seems repetitive and doesn't add much, therefore could be woven into paragraphs 1-2 (lines 29-52). It would be better served to outline any prior buddy selection tools that have been used in this population or others. If this is a novel idea, there should be more background as to why the authors thought this would work in this population.

Methods --

lines 102-110 -- How were the guides developed? Could you provide example questions in a table in the supplement or if you feel important, into the main paper? Were there separate guides for clinicians, patients and TBYs? What topics were asked about (I see briefly on lines 88-89, but that is too brief and should be probably moved to around lines 102)?

lines 96-101 -- Seems like most patients were paired with their TBYs and you mention dyads later, but no mention of dyadic analysis in your methodology. If you did do dyadic analysis, you should explain more in the Methods. If you did not, I would probably drop mentions of dyads (lines 164 and 289).

line 127 -- there needs to be a sentence or two making it clear that the tool is meant to be used by PLHWA to identify TBY because in the pilot test, TBYs were also consented for some reason and it was a little confusing.

lines 141-143 -- the consenting of TBYs for the pilot test is confusing. Perhaps they were consented for another process that is not mentioned in the manuscript. For that reason, either clarify why that needed to happen (what role TBYs played in the pilot test -- did the PLWHA verbally ask the TBYs questions from the selection tool?) or remove.

lines 148-149 -- More needs to be described about the invitation of Phase 1 participants to the CAP and why that decision was made (recruitment difficulties?). It seems like the CAP served as a group cognitive interview to refine the tool more that an advisory panel. An advisory panel seems like an opportunity to get other stakeholders involved (experts, patient advocacy groups, etc.). Methodologically, the CAP should probably be described more as a cognitive interview vs. panel.

Results --

Line 249 -- No mention of how the tool is scored after revision. You mention Likert scales, but scoring and decisions about any reverse coding, etc. need to be described. And how does the scoring help the PLWHA decide to select that person as a TBY or not? That is really important to include.

Lines 272-277 -- Another opportunity to discuss scoring here. And how do you envision tool use in real-world practice (i.e., does the clinic provide the tool to PLWHA, do they find it online themselves)?

Discussion --

Lines 279-300 -- There needs to be expansion on the similarities and differences between interview findings from clinicians and patients and TBYs, any gaps, what might the study find on expanded testing of the selection tool and how might they envision the rollout of this delivery model?

Minor:

Introduction --

line 34 -- there is no mention of side effects (or lack of) of LAI-ART along with effectiveness and acceptability.

line 35 -- you might provide a better term than specialized personnel, as it is not clear what is meant (do you mean prescribers?) It begs the question, if specialized personnel are needed in the clinic, how can the treatment be delivered by TBYs?

lines 44-45 --- decentralized drug delivery models as opposed to injection models

Methods --

lines 84-86 -- is it important to name the sites? May de-identify since there are small participant numbers.

line 111 -- thematically analyzed

line 116 -- consider adding codebook with themes, subthemes and descriptions to a table in main text or supplement

line 119 -- consider adding saturation table by theme/subtheme into supplement

Results --

line 233 -- study team or coding team members as opposed to analysts

line 234 -- Is "1-year" commitment important? This is the only time it is mentioned and is very specific. Why not just commitment to injection schedule with no time frame?

Line 254 -- The selected TBYs, as opposed to TBYs selected.

Line 309 -- this particular approach

Lines 319-324 -- Strengths and Limitations should be moved to Discussion instead of Conclusions.

Table 1 -- You might consider collapsing some categories as many of your cell sizes are n=1.

Table 3 -- Could add some scoring details here.

Figure 1 -- Does not add much, could use the space for something else like table with codebook, example interview questions, or scoring details

Supplemental Info --- Attachment of IRB approval letters to manuscripts typically not necessary. Stating IRB approval in Methods is enough. Could use Supplement for codebook, example interview questions, scoring details and/or saturation table instead.

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Reviewer #1: No

Reviewer #2: No

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"Picking the right person ... can make or break the whole deal": Development of a layperson injector selection tool for administration of home-based long-acting injectable antiretroviral therapies

PONE-D-25-67939R1

Dear Dr. Bourdeau,

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,

Omar Sued, MD, PhD

Academic Editor

PLOS One

Additional Editor Comments (optional):

Reviewers' comments: