title: Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa.
abstract: 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.
authors.affiliation: Women's Global Health Imperative, RTI International, San Francisco, California, United States of America ; Center for AIDS Prevention Studies, Department of Medicine, UCSF, San Francisco, California, United States of America.
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
authors.affiliation: Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Stadler
authors.affiliation: Women's Global Health Imperative, RTI International, San Francisco, California, United States of America.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Montgomery
authors.affiliation: Women's Global Health Imperative, RTI International, San Francisco, California, United States of America.
authors.forename: Miriam
authors.initials: M
authors.lastname: Hartmann
authors.affiliation: Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Busiswe
authors.initials: B
authors.lastname: Magazi
authors.affiliation: Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Florence
authors.initials: F
authors.lastname: Mathebula
authors.affiliation: FHI 360, Research Triangle Park, North Carolina, United States of America.
authors.forename: Katie
authors.initials: K
authors.lastname: Schwartz
authors.affiliation: Women's Global Health Imperative, RTI International, San Francisco, California, United States of America.
authors.forename: Nicole
authors.initials: N
authors.lastname: Laborde
authors.affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases/National Institutes of Health, Bethesda, Maryland, United States of America.
authors.forename: Lydia
authors.initials: L
authors.lastname: Soto-Torres
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D005260:Female; D017144:Focus Groups; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control*; D006801:Humans; D055118:Medication Adherence; D008875:Middle Aged; D008962:Models, Theoretical; D065129:Pre-Exposure Prophylaxis; D036301:Qualitative Research; D013019:South Africa; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use*; D014930:Women; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D014622:Vaginal Creams, Foams, and Jellies