Background: Although significant progress has been made in clinical trials of women-controlled methods of HIV\nprevention such as microbicides and Pre-exposure Prophylaxis (PrEP), low adherence to experimental study\nproducts remains a major obstacle to being able to establish their efficacy in preventing HIV infection. One factor\nthat influences adherence is the ability of trial participants to attend regular clinic visits at which trial products are\ndispensed, adherence counseling is administered, and participant safety is monitored. We conducted a qualitative\nstudy of the social contextual factors that influenced adherence in the VOICE (MTN-003) trial in Johannesburg,\nSouth Africa, focusing on study participation in general, and study visits in particular.\nMethods: The research used qualitative methodologies, including in-depth interviews (IDI), serial ethnographic\ninterviews (EI), and focus group discussions (FGD) among a random sub-sample of 102 female trial participants,\n18 to 40 years of age. A socio-ecological framework that explored those factors that shaped trial participation and\nadherence to study products, guided the analysis. Key codes were developed to standardize subsequent coding\nand a node search was used to identify texts relating to obstacles to visit adherence. Our analysis includes coded\ntranscripts from seven FGD (N = 40), 41 IDI, and 64 serial EI (N = 21 women).\nResults: Women�s kinship, social, and economic roles shaped their ability to participate in the clinical trial. Although\nparticipants expressed strong commitments to attend study visits, clinic visit schedules and lengthy waiting times\ninterfered with their multiple obligations as care givers, wage earners, housekeepers, and students.\nConclusions: The research findings highlight the importance of the social context in shaping participation in HIV\nprevention trials, beyond focusing solely on individual characteristics. This points to the need to focus interventions\nto improve visit attendance by promoting a culture of active and engaged participation
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