Amsterdam 2015
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| Abstract #2100 - Research to implementation science and practice | ||||
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Session: 26.4: Research to implementation science and practice (Parallel) on Thursday @ 11.30-13.00 in C104 Chaired by Wendee Wechsberg Authors: Presenting Author: Dr Ariane van der Straten - RTI International, United States |
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| Additional Authors: | ||||
| Aim: MTN-003D, an exploratory follow-up study of potential sources of efficacy dilution in the VOICE trial, used In-depth-Interviews (IDIs) and Focus Group Discussions (FGDs) to explore the context of high risk sexual behaviors and reasons for non-adherence. | ||||
| Method / Issue: In the VOICE trial, daily oral or vaginal tenofovir (TFV) – based Pre-Exposure Prophylaxis (PrEP) was not effective in reducing HIV acquisition in women, given poor adherence as determined by low plasma TFV detection among participants assigned to active products. Self-reports of study product adherence were considerably overestimated among many trial participants. In addition, there were concerns about the accuracy of VOICE trial data regarding high risk sexual behavior, including penile-anal intercourse (PAI). VOICE findings highlighted the need to identify different approaches to collect information on sensitive topics in the context of clinical trials | ||||
| Results / Comments: We developed and adapted a variety of tools and strategies to promote candid discussion of these topics among 175 former VOICE trial participants in Zimbabwe, South Africa and Uganda. A body map tool, adapted from sexual and reproductive health studies, showed the front and back outline of a nude female figure, and was used during IDIs to initiate and clarify discussions of sexual behaviors. Interviewers asked women to identify and discuss genitalia and other body parts associated with sexual behavior, pain and pleasure. Participants’ responses (key words or short sentences) were noted on the map. We also developed four strategies to encourage open discussions of adherence challenges and explanations for non-use of study products during VOICE: 1) presentation of local media clippings about VOICE results 2) a pilot-tested illustration of teapots and full or empty tea cups representing participants’ drug detection patterns during VOICE 3) a series of evidence-based statement cards listing 20 challenges related to trial participation or adherence and 4) identification of IDI participants who were open about non-adherence to act as conversation “sparks” during FGDs. | ||||
| Discussion: Body map tools facilitated open and unambiguous discussion around sexual behaviors, and enabled participants to refer to body parts or sexual acts without having to verbalize potentially embarrassing anatomical terms. When used in combination with IDIs, body maps enhanced discussions around sexual behavior, specifically anal sex. When included, conversation “sparks” successfully stimulated discussion in FGDs. The “teapot” tool helped understanding and supported discussion and explanation of drug detection patterns, a difficult scientific concept to grasp. The statement cards allowed for systematic exploration of adherence challenge saliency and identification of new themes. Similar cards are currently being explored as a technique to elicit information during product adherence counseling at a clinic in South Africa. Culturally appropriate visual tools and innovative strategies can improve understanding and facilitate discussion of scientifically complex or socially sensitive concepts in the context of clinical research. | ||||
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