Title: Changes in relationships, HIV risk, and feelings towards PrEP: findings from a qualitative
explanatory study among participants in the CHARISMA intervention trial
Version: 3 Date: 28 Jun 2023
Reviewer's report:
This original manuscript presents results from a qualitative exploration of participant
experiences in the CHARISMA intervention trial-. Using thematic case analysis, semi-
structured in-depth interview data suggested that women experienced changes in relationships
and empowerment and, for some women, this contextualized decisions to discontinue PrEP.
Although the work is highly relevant and of potential impact, a few areas could be strengthened.
Comments to consider or address are provided below.
Specific Comments
Introduction. Check format for in text reference for line 6 page 4- should reference (3) be outside
the parentheses for IPV?
Introduction. In the final line of the introduction the authors note aiming to understand what
works and for whom. Consider adding ‘when’ given the longitudinal nature of the interviews
and emphasis on shifting or changes in PrEP need over time.
Methods. Line 24 page 5. Should the text read- …South Africa ‘who were’ ages 18-45…
Methods. Line 6 page 6. Check grammar- ‘…relationships and behavior, [and] experience of
violence, and dried…’
Methods. Line 8 page 6. Were women also linked to PrEP care/services at exit?
Methods. Can the authors note if the counseling (intervention and control) was delivered at each
study visit (enrollment, m1, m3, and m6)?
Methods. Add targeted enrollment numbers for specific arms- results present 3 standard of care
counseling arm participants and 9 intervention arm participants.
Methods. Page 7 line 12, a total of 9 participants from the intervention and 3 from comparison
counseling condition is not immediately appreciable as enough for commonalities in experiences
to emerge.  Hanafizadeh and Kaiser (2018) and Guest et al (cited by the authors) suggest
a minimum of 5 and 12 respectively for saturation- depending on type of saturation- for
homogenous groups. The current work meets the 12 criteria for all participants, but if looking
for mechanisms of change for intervention arm participants, 9 total may be insufficient for
saturation according to Guest. Consider revising this section to include references that would
support smaller sample sizes – like Hanafizadeh or Malterud et al’s (2016) approach of using
information power (e.g., exploratory qualitative analyses seeking new insights need not saturate
to have high value).
Methods. Analysis- Please provide additional clarity to the analytic approach. Define ‘prescribed
memo’ and if these were for the full case (each interview) or done for each interview separately.
Were the case memo’s the unit of analysis? Were these then entered back into dedoose or
were these generated from ‘first pass’ of coded data in dedoose, consolidated outside of it,
and interpreted by the team? Was intercoder reliability on the code application to transcripts
in dedoose?
Results. Please provide information on the study arm for the 3 missing their 9 month interviews.
Results. Consider adding “participants [in the qualitative sub-study] were…” on line 8 page 9.
Results. Should the adherence classification approach be defined in the methods or was this
indeed a result of the work conducted?
Results. Did adherence classification factor into the purposive sampling?
Results. Table 1. Typo “condom us[e]”
Results: Table 1. Consider providing total N for first and follow-up interviews.
Results: In text, differences between intervention arm and comparison active control condition
are noted and subtle differences between intervention arm participants engaging in different
specific intervention components are noted. Consider creating a table of themes, theme
definition, example quote and nuances (differences observed between arms or between
participant in the intervention condition). Some way to provide an overview of findings to
complement text would be helpful. Alternatively, incorporating qualitative findings into Figure
1, adding in control condition, as a visual display may provide a comprehensive snapshot. Either
would provide a clearer picture for when some women (e.g., those IPV counseled) appeared to
have different experiences than other women. Also of interest would be any differences between
those who discontinued PrEP use from those who persisted with PrEP.
Results: Page 13. The quote for the case of apologizing was difficult to follow as an example
of change in willingness to apologize.
Results: Page 14. Difficult to follow “…except cases who received IPV counseling who feared
their partners’ reactions…” Does that leave participants who did not receive IPV counselling or
participants who may have received IPV counseling but in any case did not fear their partners’
reactions? Does that mean there were those who did fear their partners’ reactions but still
disclosed? Can this be clarified?
Results. Page 14. Can the authors clarify ‘…using violence.’ Is this specifically referring to
physical violence? Can the reader assume that the verbal reactions were not verbally abusive?
Results. Page 16. Given that women may have discontinued use by 6 months, consider framing
as challenges with Adherence and Non-persistence or PrEP Discontinuation?
Results. Page 16 line 5, states “…in addition to the partner-related challenged noted above…”
but text above is about structural challenges accessing PrEP.
Results. One of the aims is to understand mechanisms of change. Results, as presented, do not
seem to consolidate these into one section- having a specific section on this would be helpful.
The results do cover change more generally (what changed for women during/attributed to the
intervention)- content of change. A brief section pulling out mechanisms of change implied
by or covered in the themes of intervention/study experiences (e.g., personal growth, enhanced
comfort discussing HIV risk, improved communication) would bring out these insights clearly.
Discussion. Page 18. Typo? Line 7 ‘women’s decisions [these] may reduce…’
Discussion. Page 18. Why was stability in relationship assumed? Was this part of the inclusion
criteria for the main study- stable relationship? Only 1 participant reported co-habitation at 6
month interview per Table 1.
Discussion. One would imagine that effective implementation of LIVES would include
discussion of content that may have overlapped with intervention content, however this is part of
having this approach as an active comparison condition. Contamination would seem appropriate
to assume if the participants received the specific intervention as detailed in the intervention
protocol, versus content that is shared between the conditions. It is not clear that shared content
is contamination.
Discussion. Consider revising limitations entry sentence- no study is without limitations.
Discussion. Limitations paragraph notes “For one,…” and then presents only one. Additional
limitations to consider: (1) single perspective (women are interviewed, no dyads of women and
partners or interview of partners to gain an understanding of relationship changes); (2) Few were
or had recently experience of IPV in their relationships (limiting representation of experiences
of women in abusive relationships); (3) Three participants did not have follow-up information
(may limit perspectives from women who discontinued who may be unique from completers);
(4) Experiences are at a specific place and time in relation to PrEP roll-out, availability, and
community level acceptability (themes may or may not be relevant in contexts of PrEP being
highly accepted and easily accessed in communities). The authors need not list all possible
limitations, but a more comprehensive representation may be warranted.
Conclusion. Given the possibility that women made ‘prevention appropriate’ decisions around
PrEP (including discontinuation) – can the final line of the manuscript be expanded to reflect on
the possibility that we need to put “women at center” for interventions across diverse outcomes
(including HIV) such that success may be need to include wellbeing more generally as a critical
component in self-care, and, importantly, strategies that are valued by participants which may
not be biomedical?