Reviewer's report
Title:Biological factors that place women at risk for HIV: Evidence from a
large-scale clinical trial in Durban
Version:2Date:26 December 2014
Reviewer: Jamila Stockman
Reviewer's report:
MAJOR COMPULSORY REVISIONS
Abstract
1. Introduction and conclusion sections are underdeveloped and weak.
2. The methods section should be edited accounting for the detailed comments
presented below.
Introduction
1. On page 4, line 73, it is unclear what is meant by “clinical findings.” It is used
out of context in this sentence.
2. There is considerable evidence that HSV-2 increases susceptibility to HIV
infection. This should be highlighted in the introduction section given the wealth
of data on this issue.
3. Page 4, line 84 – the word, “despite” is inappropriate for what I believe the
authors are attempting to convey. Alternate wording is “In addition to.”
4. The introduction is underdeveloped. There is lack of background on studies
that have examined the biological nature of the mucosal surface of women’s
lower reproductive health tract and its susceptibility for HIV
transmission/acquisition. Further, since the abstract states that the study the aim
is “to assess whether any damage to the vaginal, vulval, perineum integrity
contributed to the increased rate of HIV infection,” there is no background
information to substantiate the need for this line of investigation since this (i.e.,
damage) is essentially not presented in this section. The introduction section
should conclude with a presentation of the objective(s) of the study, sample
hypotheses, and public health implications.
5. Page 5, lines 93-101, conveys methods relevant to the proposed study. This
information should be integrated into the methods section.
Methods
1. Page 5, lines 104-105 – the sentence is incomplete.
2. Page 5, lines 105-107 – the authors state the study sites being in South Africa
and Zimbabwe but only Durban and Bohas Hill are mentioned. I know that
Durban is in South Africa but this should be clarified. And if Bothas Hill is near
Durban, what areas of Zimbabwe were included? This section is confusing.
3. There is no mention of the sample size in the methods section. Also, there is
no mention of the response rates.
4. The clinical data collection section is unclear. It seems as though some of the
measures were based on self-report (e.g., demographics, sexual behaviors,
treatment of STIs or reproductive tract infections) but this is not clearly
delineated. Further, there is no statement on how these data were collected (e.g.,
self-administered surveys, interviewer-administered, ACASI). Also, were
participants compensated?
5. Page 7, line 149 – “risk factors of interest” is vague.
6. After reviewing the entire manuscript thus far, the objective does not match the
analysis plan. There is no indication that the analysis will focus on “damage to
the mucosal epithelial as a result of trauma” so there is a mismatch in the
objective and analysis. The authors are encouraged to refer to the literature on
more appropriate terminology to convey their objectives to avoid misleading the
reader.
7. It was also unclear what the follow-up periods were in terms of assessment.
There was no mention of the number of visits women completed and what visit
and timeframe were used for the variables of interest.
Results
1. The results section is missing key elements such as a Table 1 to document the
characteristics of the study sample.
2. Page 8, lines 164-166 – besides being relevant to the parent study’s aims, it is
unclear why the proportion preferring the use of injectables as a method of
contraception were included in the current paper.
3. Page 8, line 167-168 – 33% does not represent the majority of women,
especially since this estimate is well under 50%. Similarly, 35% does not
represent the majority. Areas where “data not shown” is mentioned should have
data shown in the form of a table.
4. Page 8, line 180 – how was “disruption of the genital epithelium” measured
and defined? This variable was not mentioned in the methods section at all.
5. There was no mention of any potential confounding variables that were
considered in the analysis.
Discussion
1. The discussion section is poorly written and significantly underdeveloped. The
discussion section should begin with a summary of the findings followed by an
in-depth discussion of how and why their results were consistent or inconsistent
with the literature. Then a discussion on
2. Page 9, line 202 – it is inappropriate to state, “According to [12]”; the authors
should actually state the last name of the first author followed by et al.
3. There are a significant number of sentences requiring citations.
4. The authors state (again, without any citations) that “Similarly non-ulcerative
STIs such as gonorrhea, Chlamydia, and trichomoniasis have also been
associated with increased HIV susceptibility,” however the current study did not
support this and this warrants discussion.
5. The authors state the impact that sexual abuse can have on HIV acquisition.
Although important, the current study did not have any variable included to
examine sexual violence, which is a significant limitation. These statements as
currently written, seem out of place and irrelevant given this lack of investigation.
6. Page 10, lines 221-222 – the sentence beginning, “RTIs such as…” is
incomplete.
7. There needs to be discussion on possible reasons why the baseline STIs were
not significantly associated with HIV acquisition rather than just simply stating
this and only included one reason that is not thoroughly presented.
8. The conclusion section is extremely weak with no implications for intervention
and future research discussed. Also the limitations are vague and there is no
mention of the strengths.
9. At the end of this paper, I was left with wondering how this study was novel
and filled existing gaps in the literature.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests.