MTN-003C

Primary Objectives

• Explore socio-cultural and contextual factors that participants identify as influencing product use (and non-use) in VOICE
• Determine if factors identified by participants as influencing product use (and non-use) are different between those who are randomized to the vaginal product arm vs. oral product
• Elicit Group 1 (VOICE participants at VOICE-C site[s]) participants’ perceptions of the importance of adherence and their experiences of barriers and facilitators to adherence

Study Summary
The VOICE Community Substudy was implemented at a single VOICE site in Johannesburg, South Africa. VOICE-C assessed the impact of household factors and community perspectives on reported product adherence by women, utilizing both behavioral research and ethnographic approaches. The VOICE-C study collected data from VOICE participants, male partners of participants, members of the site’s Community Advisory Boards (CABs), and key community stakeholders. Study staff members solicited the input of external stakeholders on developing and implementing strategies to improve product adherence in the trial and collected feedback on participants’ experiences with implementation strategies via exit focus group discussions. The use of qualitative methods in VOICE-C provided insight into the context in which women were asked by VOICE researchers to use their study products. The study also provided information on the complex relationships among those who conduct clinical research, participate in the research, and live in the communities where clinical research takes place.

MTN-003C completed follow-up on August 22, 2012. Primary results were first presented at the International Conference on HIV Treatment and Prevention Adherence conference held on June 3, 2013, in Miami, FL. The primary manuscript was published in PLoS One on February 21, 2014. A total of seven papers have been published from this study.

Primary 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.