Reviewer ’s report  
 
Title: Qualitative exploration of intrinsic and extrinsic factors that influence acceptability of 
semisoft vaginal suppositories  
 
Version: 2 Date: 01 May 2018  
 
Reviewer: Barbara Friedland  
 
Reviewer's report : 
 
The authors conducted a strong study, however, the authors have not made a strong enough case 
for the relevance of the data.  If the th esis is that acceptability drives adherence, where is the 
evidence that Tenofovir gel (or "solid" dosage forms) were not acceptable?  How is acceptability 
defined?  Is there a theoretical model or framework supporting this hypothesis?  
The background empha sizes adherence issues in microbicide gel trials as the rationale for 
exploring new product formulations.  If there is data indicating issues with the product's 
characteristics (vs partner dynamics and other ecological level issues), the authors should inc lude 
and emphasize this information in the background.  Otherwise, it is difficult to connect the 
previous adherence issues with the main focus of this study -- ie the physical characteristics and 
the perception of the meaning of the characteristics.  Howe ver, the reasons for low/non -
adherence in the 3 Tenofovir gel trials listed are not related to product characteristics. From this 
research, it is difficult to understand how the suppositories will fare better than gels.  
Furthermore, the authors imply the re are issues with solid dosage forms, like intravaginal rings 
(IVRs).  Yet, it is the dapivirine IVR that is currently under review by the EMA after 2 pivotal 
trials demonstrated efficacy. Although this study was conducted many years before the 
dapivirine  IVR study results were available, the authors should reference the trials and factor the 
results of the 2 Phase 3 trials into the background.  It is unclear what the basis is for the authors' 
opinion that there are shortcomings to the solid dosage form an d that the vaginal suppository will 
be a better option.  
It would be useful to know if the prototype products shown in the FGDs are being developed 
with APIs.  How are the results of this study going to be used for product development?  
The authors should explain why the study was conducted at a university in the US, whereas the 
adherence issues reported were in sub -Saharan Africa (SSA).  Can the authors make a stronger 
connection between the data from this study and the adherence issues seen in SSA?  How are 
these findings relevant for improving adherence among women in SSA?  
Finally, the authors do not mention the key limitation to this study:  participants only handled the 
suppositories but did not insert them vaginally, nor did they us e them in conjunction with sexual 
intercourse.  The authors should emphasize this as a limitation and talk about how data from 
other "hypothetical" research has shaped product development (or not).  Furthermore, the authors 
should mention as a limitation t hat this study was conducted among a well -educated US 
population and may not translate to women in SSA.  
In summary, the study design, methods, and results are explained well; however, a much stronger 
rationale is needed to link the data from this study to  the future of microbicide product 
development.  
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Unable to assess  
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your  comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in you r comments to the editors.  
 
Not relevant to this manuscript  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
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