title: Influences on visit retention in clinical trials: insights from qualitative research during the VOICE trial in Johannesburg, South Africa.
abstract: BACKGROUND
  Although significant progress has been made in clinical trials of women-controlled methods of HIV prevention such as microbicides and Pre-exposure Prophylaxis (PrEP), low adherence to experimental study products remains a major obstacle to being able to establish their efficacy in preventing HIV infection. One factor that influences adherence is the ability of trial participants to attend regular clinic visits at which trial products are dispensed, adherence counseling is administered, and participant safety is monitored. We conducted a qualitative study of the social contextual factors that influenced adherence in the VOICE (MTN-003) trial in Johannesburg, South Africa, focusing on study participation in general, and study visits in particular.
  
  
  METHODS
  The research used qualitative methodologies, including in-depth interviews (IDI), serial ethnographic interviews (EI), and focus group discussions (FGD) among a random sub-sample of 102 female trial participants, 18 to 40 years of age. A socio-ecological framework that explored those factors that shaped trial participation and adherence to study products, guided the analysis. Key codes were developed to standardize subsequent coding and a node search was used to identify texts relating to obstacles to visit adherence. Our analysis includes coded transcripts from seven FGD (N = 40), 41 IDI, and 64 serial EI (N = 21 women).
  
  
  RESULTS
  Women's kinship, social, and economic roles shaped their ability to participate in the clinical trial. Although participants expressed strong commitments to attend study visits, clinic visit schedules and lengthy waiting times interfered with their multiple obligations as care givers, wage earners, housekeepers, and students.
  
  
  CONCLUSIONS
  The research findings highlight the importance of the social context in shaping participation in HIV prevention trials, beyond focusing solely on individual characteristics. This points to the need to focus interventions to improve visit attendance by promoting a culture of active and engaged participation.
authors: Busisiwe
authors: B
authors: Magazi
authors: Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, PO Box 18512, Johannesburg, South Africa. Jstadler@wrhi.ac.za.
authors: Jonathan
authors: J
authors: Stadler
authors: Sinead
authors: S
authors: Delany-Moretlwe
authors: Elizabeth
authors: E
authors: Montgomery
authors: Florence
authors: F
authors: Mathebula
authors: Miriam
authors: M
authors: Hartmann
authors: Ariane
authors: A
authors: van der Straten
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001071:Appointments and Schedules; D005260:Female; D017144:Focus Groups; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D010349:Patient Compliance / Q000523:psychology*; D010352:Patient Dropouts / Q000523:psychology*; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D013019:South Africa; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents