Reviewer’s report
Title: 
Acceptability and feasibility of the CHARISMA counseling intervention to support women’s use of
pre-exposure prophylaxis
Version: 
0 
Date: 
30 Nov 2020
Reviewer's report:
Abstract
A starting question is how to judge the intensity and duration of counselling as appropriate ? Should this
be from a client viewpoint (acceptability) as suggested by the study title or from a systemic viewpoint
(feasibility). Why were the staff's commentaries and beliefs rather than data such as number of questions,
time taken to answer, document, counsel made a main focus ?.
Encouraging honesty and openness from clients is commendable and reported clinical experience with
intimate partner (domestic) violence during pregnancy suggests women are more likely to open up to staff
(even on a 1st visit) provided confidentiality is assured, and the interview takes place in conducive
surroundings. Can the authors support this pilot with previous studies suggesting that it takes a prolonged
period ?. 
The authors suggest the use a computerised (interactive) alternative /proxy in different settngs where
CHARISMA recommended duration and modes of counselling cannot be provided ? Was this suggested
by their study participants initially or did they propose this ?. 
Itemised Review
L36 How did participants assess the length of counselling as being right for them ?.
Line 39 This paragraph is a conclusion not a result. "Based on these promising preliminary findings, the
project team is currently conducting a randomized controlled trial in which participants are receive (sic)
either the standard of care for IPV screening and referral (control arm) or the CHARISMA intervention.
L69 is acknowledgement of a basic fact and should probably be followed up by an assessment of the
degree to which both a priori partner and post-intervention involvement was not possible in a) the
background Johannesburg population b) the study group of women.
Braksmajer et al, 2016 acknowledge the potential for covert or autonomous use, as an advantage of PrEP
use in their American population, indeed an ideal PrEP agent would be independent of partner
involvement. There is no clear information stated by the authors here regarding this issue in the South
African population of the current study. 
There is also no comparison of like with like here as previous studies point out that there are differences
between vaginal gel versus oral PrEP use and the two may be better separated for study even in a pilot
situation. Other factors such as finances or the recommendation that PrEp users undergo regular medical
follow ups to monitor side effects etc may be more significant deterrents.
As Braksmajer et al stated, while they "drew on evidence related to other female-controlled methods "
(e.g., vaginal microbicides) to speculate on issues that might be related to feasibility and 
acceptability of
PrEP use among women in violent relationships, these might not be directly comparable.
There are several publications that clearly identify the risks of threats and other factors reducing the
likelihood of PrEP use in women and this section on study justification should be re-written to permit
readers better understanding by including clearer information on the particular South African population
under study.
In reporting the VOICE-C trials, Van Straten et al 2014., point out divergence between serum levels of
PrEp and self reported adherence or clinic attendance, and Montgomery 2014 state the important point
that adherence to oral PrEP may be reinforced by supportive spouses among serodiscordant couples,
quoting an abstract from a 2011 conference on PrEP. The latter while acknowledging the fact that
quantitative data cannot be ascribed from a qualitative study still went ahead to quote a "substantial
influence of the male partner" because of the consistency of the reporting by the women interviewed. 
Can the study authors reliably conclude that counselling using CHARISMA rather than (as suggested by
Montgomery) forewarning of the male partner that improves uptake ? However, this may well be true in
that an active component of CHARISMA counselling that cannot be over-emphasised is "constructive
involvement of the male partner".
L81 onwards - Can the authors explain their study subjects and criteria in more detail right from the start.
Is this a secondary analysis of a previous study group ? If this is the case, the authors might wish to
highlight that their study group is secondarily derived from the onset as this is a little confusing - was this
a considered primary outcome from the ASPIRE/CHARISMA trials from their inception and where did
the vaginal microbicides and oral PrEp fit in?. 
There are some issues with studying acceptability and feasibility without demonstrating effectiveness for
prophylaxis in the study group, because documented registration of the MTN 025 continuation was to be
contingent on Dapivirine being of proven efficacy i.e. "if MTN 020 the ASPIRE trial demonstrated
effectiveness", this now seems to have been omitted from the current study on CHARISMA.
Reference 20. Pallitto et al., 2016 refers to a widely quoted, published protocol. Have the relevant study
results/outcomes been referenced ?.
L196 92 women had HEART counselling modules and the authors describe "Most participants (n=54)" as
receiving the IPV module - 54 is equivalent to 58.7% which though substantial is not an overwhelming
majority, or did the authors mean as a proportion of those women that received one of the added three
modules - IPV, Partner Communication and Ring Disclosure ? . 
L203 needs more explanation on gender roles in the Johannesburg culture (Were they all black women ?).
L207-209 and 
234-236 again contradicts the suggestion by the authors earlier of alternative counselling
interactions using computers.
L228 
Most women who received the IPV counseling said that it empowered them, but some said that it
was not relevant to them. ??? 
An interesting aspect of this study for the purpose of future research by
others, is the aspects of the counselling modules that made the change as described in Table 3. I would
suggest that the authors review the influence of their counselling tool in positively empowering the
participating women in the light of their own comments. This s a positive aspect of the CHARISMA tool
that should be highlighted by them. 
L230 Why were specific timings for the interviews not measured and charted ? Afterall these were taped
and transcribed. It would have provided a more objective assessment of how useful length/duration of
counselling was specifically. This especially as in L311, the staff personally expressed the feeling that the
Charisma intervention was lengthy to administer.
L236-240 again demonstrate the cons of the earlier suggestions against the use of computer based
counselling tools for this sensitive work. While it seems that there was a positive effect in IPV from the
CHARISMA intervention, the numbers in this study are relatively small, nonetheless the impact should
also be highlighted.
L282-285 is anecdotal and being speculative, should be restated by the study authors in a manner that
reflects the facts. 11.96% reported IPV, was this under-reported ? how does it compare with figures from
other parts of the country? different parts of the world ? . The statements made here and repeated in L356-
358 cannot be seen to be conclusive in their suggestion that IPV is normalized in South Africa without
clearer evidence ("staff said that IPV is normalized in South Africa, so it can take time for participants to
begin to recognize IPV in their relationship and be ready to take action on it; therefore, the ongoing
support is important to help them reach that stage).
L296-305 would be better received if these comments are validated by client satisfaction audit as part of
the study - in this context they may again appear conjectural.
L333-335 This statement should be quantified with study data on numbers/percentages 
for the reasons for
partners non-attendance.
L354 "External" organisation not "outside" organisation. An observation is that the views of the KII staff
appear over-represented in this study which had the stated objective of assessing examine the influence of
CHARISMA, not work from pre-existing opinions and beliefs without a validated basis. 
L397-398 - To quote the authors "The pilot study offers several lessons learned regarding the
implementation of CHARISMA that may be applicable to similar interventions." Sound justification
should be provided for this. The statement is followed by a discourse in part based on comments from
staff. Can the 
authors explain how this is directly related to the study hypothesis ?
L402 
"The length and intensity of CHARISMA may not be feasible in some settings, but a shorter, less-
intensive version of the intervention may not offer as much support as women and staff need." How did
the authors arrive at this conclusion ? The explanations do not present a direct result/s obtained from
study and offer pre-suppositions in 
L409 "intervention delivery may vary by age group, setting, or other
factors" How was this concluded ? Literature search ? Data ? Clearer information is required.
L410 A statement such as this should be backed by valid data as the authors themselves later indicate
(L412). 
Line 415 is a crux in the issue under study - partner role in determining women's use of PrEP, but the
objective of this study was to assess CHARISMA as a counselling intervention 
which should be the focus.
How did CHARISMA affect the influencing of partners ? There are several statements by the authors
about partners' invitation to attend with the women not directly related to this. The bottom line is what
were the pre- and post-intervention results, was there any significant or indeed, detectable change
following intervention ? In addition (L421), clinic staff are described as becoming directly involved - this
study is about CHARISMA intervention not staff with L428-431 detailing the appropriate steps. The
irrelevant section should be omitted.
L432-452 describe the intertwining of three research studies - ASPIRE, HOPE, CHARISMA, this seems
rather convoluted and how did the authors propose to eliminate any resulting bias from one study to
another ?. This is confusing for the reader. The authors final admission "The pilot study design was single-
group, post-test only, making it difficult to attribute results to the intervention" begs the question as to
why this study was conducted. Was there a planned study design that addressed all the issues arising from
peer review ? .
L456 Conclusions 
: While one can agree with the conclusion that intervention could enhance partner
involvement, reduce IPV and improve uptake and adherence to women's PrEP use the authors need to
script a more convincing report on a possible direct influence of CHARISMA.
L463-467 
"Lessons learned from the pilot" is a rather strong phrase 
because the evidence presented in this
study does not appear completely objective, rather "Questions arising" may be a more appropriate
descriptive phrase. 
L467 While staff observations and comments are important, they may well be a secondary issue in a study
assessing feasibility and acceptability by women and the concluding statement that more specific research
is needed is true.
There were 3 tables and one figure with study data, and one table with qualitative data, the authors may
wish to consider revising the manuscript with a tighter focus on these and the other reports from their data
which are key to assessing the intervention under study. While the other issues described by staff and the
authors may make interesting reading, much of these may not be directly related to the study question.
Summary of Review
This study sought to determine the acceptability and feasibility of the CHARISMA counseling intervention
to support women's use of pre-exposure prophylaxis (PrEP). After review, one is left with a feeling that
the reported observations from a cohort of women post counselling using CHARISMA and staff dialogue
and commentary could be an attempt to combine qualitative with quantitative data on the subject matter. 
A
simple phenomenological approach may be helpful. At best , this is a descriptive study similar to that by
Pallito et al., and is possibly better written in that format.
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Is the study design appropriate to answer the research question (including the use of appropriate controls),
and are the conclusions supported by the evidence presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
Yes
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No
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No
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manipulation?
Yes