Public area - News, events, announcments - Topic started by Silvia Petretti - April 30 2014, 02:40 pm

Title: Women's challenges in adherence examined by VOICE trial qualitative research
Post by: Silvia Petretti on April 30 2014, 02:40 pm
Qualitative research from the VOICE trial reveals women’s challenges in adherence.

Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa.

van der Straten A, Stadler J, Montgomery E, Hartmann M, Magazi B, Mathebula F, Schwartz K, Laborde N, Soto-Torres L. PLoS One. 2014 Feb 21;9(2):e89118. doi: 10.1371/journal.pone.0089118. eCollection 2014.

Background: In VOICE, a multisite HIV pre-exposure prophylaxis (PrEP) trial, plasma drug levels pointed to widespread product nonuse, despite high adherence estimated by self-reports and clinic product counts. Using a socio-ecological framework (SEF), we explored socio-cultural and contextual factors that influenced participants' experience of daily vaginal gel and oral tablet regimens in VOICE.

Methods: In Johannesburg, a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews (n = 41), serial ethnographic interviews (n = 21), or focus group discussions (n = 40). Audiotaped interviews were transcribed, translated, and coded thematically for analysis.
Results: Of the 102 participants, the mean age was 27 years, and 96% had a primary sex partner with whom 43% cohabitated. Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products. The unknown efficacy of products, their connection with HIV infection, challenges with daily regimen given social risks, lack of support-from partners and significant others-and the relationship tradeoffs entailed by using the products appear to discourage adequate product use.

Conclusions: Personal acknowledgment of product nonuse was challenging. This qualitative inquiry highlighted key influences at all SEF levels that shaped women's perceptions of trial participation and experiences with investigational products. Whether these impacted women's behaviors and may have contributed to ineffective trial results warrants further investigation.

Abstract   Full-text [free] access
Editor’s notes: VOICE C was a qualitative ancillary study looking at experiences of women participating in the larger VOICE clinical trial which tested the efficacy of oral pre-exposure prophylaxis (PrEP) and topical microbicides. Two of the three active study arms for VOICE were stopped early for futility. The third arm continued to the planned completion date, but the activities in this arm were also found to have no effect. In this regard, VOICE C became very important in understanding what happened during the trial, since participants reported a high rate of adherence and we know that PrEP works if taken. Once bloods were analysed to look at drug levels, it was found that few participants were regularly taking the study medication. Data emerging from VOICE C revealed that women elected not to take the drugs due to boredom with the study, issues with side effects and health status, and difficulties managing social relationships. Interestingly, women admitted that they knew other participants were also not taking their study medications. These discussions between women took place when participants were in contact with one another such as in waiting-rooms. Perhaps the major strength of VOICE C was the design, which allowed for triangulation of data sources to create more comprehensive narratives of participants’ experiences. The study employed longitudinal in-depth interviews, serial ethnographic interviews, and focus group discussions which elicited a richness of data which would not have been available otherwise. It is clear from this study that there is much to learn about how clinical trials are conducted to ensure success. Perhaps most importantly, we need to know how participants see their roles and why they agree to be part of the study. (

Issue: HIV This Month #04 - April 2014
Target: Reduce sexual transmission
Categories: Biomedical interventions and prevention tools, Sexual transmission and prevention
Related Regions: Africa
Related Countries: South Africa

Title: Re: Women's challenges in adherence examined by VOICE trial qualitative research
Post by: Alice Welbourn on April 30 2014, 03:23 pm
Hi Silvia and all

What I wonder is this: if it is now clear that illnesses are very shortly to become untreatable by antibiotics (, because doctors oversubscribe them and people aren't good at completing the course, why are policy makers so keen to roll out ARVs in treatment as prevention programmes such as this, when it is clear from this study that there are all kinds of reasons why women (and others) don't take the ARV medication routinely? Are we not playing with fire? Are we not at risk also of developing resistance to ARVs as we have with antibiotics, malaria and TB?

I hope someone can help me on this please.

Many thanks

Alice Welbourn

Title: Re: Women's challenges in adherence examined by VOICE trial qualitative research
Post by: Gus Cairns on May 5 2014, 12:30 am
Dear Silivia, Thanks - very useful - and complements similar findings from Fem-PrEP.
This is from a forthcoming writeup by yours truly about adherence studies from Fem-PrEP:

"In one, a series of qualitative interviews with a randomly picked 5% of trial participants suggested that women joined the trial for reasons other than PrEP and that the thing they valued especially was having a monthly test for HIV.  In addition, they used the test, and participating in the trial itself, as a way of getting reassurance that they did not have HIV. The trial itself, in the minds of the women, became the prevention method offered. The three direct benefits most commonly cited of joining the trial were the monthly HIV test (32% of participants said this was an important reason for joining the trial), the support the trial gave them to stay negative (25%) and the monitoring offered for other health problems (22%). Thirty per cent also quoted helping other women as a reason.
In the second, semi-structured interviews (SSIs) with 88 former FEM-PrEP participants and 224 quantitative audio computer-assisted self-interviews uncovered a number of other reasons for non-adherence in the study.  The two most important factors were that participants did not perceive that they would benefit from PrEP as it was an investigational drug, and that there was what the researchers call “an environment of broader discouragement shaped by concerns and rumours among other study participants (i.e., peers), partners, and the community, which was reported to have led to non-adherence.”
The most commonly cited reasons for non-adherence to PrEP were as follows (these are non-exclusive figures: participants could name several reasons for non-adherence, and usually did).
•   Told by someone [most often a family member] not to take the pills: 15%
•   Deterred by the non-adherence of other participants: 22%
•   Feeling that pills were only to be taken when one was sick: 21%
•   Felt at low risk of HIV: 28%
•   Forgot: 29%
•   Was travelling: 21%
•   Too busy: 16%
•   As an investigational drug, it will probably not be of benefit: 47%
•   Perception one might be on placebo: 27%
•   Fear of side effects: 26%
•   Experience of side effects: 14%
•   Daily pill-taking is too difficult: 32%
•   The pills are too large: 27%"

  Wong C et al. Participant motivation for enrolling and continuing in the FEM-PrEP HIV prevention clinical trial. Seventh International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Kuala Lumpur, abstract WEAC0104, 2013.
  Corneli A et al. FEM-PrEP: Participant Explanations for Non-Adherence. 21st Conference on Retroviruses and Opportunistic Infections (CROI), Boston. Abstract 959LB. 2014.

Alice: This was a PrEP study, Alice, not one of treatment. It's very important to distinguish the two. For what happens when you truly roll out TasP in a concerted manner see
It was also placebo-controlled, so women were aware they might be taking something that had no effect.
PrEP is very different and inherently more problematic than TasP, but we are already seeing higher adherence rates in open-label studies. I don't see PrEP as it is at the moment being suitable for most people, just certain very highly-motivated ones. Things may change when we get quarterly injectables - or may not.

Title: Re: Women's challenges in adherence examined by VOICE trial qualitative research
Post by: Silvia Petretti on May 7 2014, 03:22 pm
Thank you Gus. very interesting.