title: Sharing of Investigational Drug Among Participants in the Voice Trial.
abstract: Product sharing among participants can impact on adherence and compromise the outcome in clinical trials. We describe incidents of product sharing at the Durban clinical research sites conducting the VOICE trial. The Durban sites enrolled 2750 women with 1103 and 1647 participants randomized to the vaginal gel and oral tablet arms respectively. Monthly pill and applicator counts including product assessments were conducted by pharmacists. Discrepancies with product counts prompted discussions with participants. Thirty-two cases of product sharing were identified. Vaginal gels were more commonly shared than oral tablets. Product sharing between study participants and their female friends or relatives living in the same household was identified as the most common source of product sharing in this analysis. Study product counts and pharmacist-driven discussions with participants may help to identify reasons for product sharing and inform the development of strategies for PrEP implementation outside of the research setting. ClinicalTrials.gov number: NCT00705679.
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, 123 Jan Hofmeyr Road, Westville, Durban, 3630, South Africa. jeeva.moodley@mrc.ac.za.
authors.forename: Jeeva
authors.initials: J
authors.lastname: Moodley
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, 123 Jan Hofmeyr Road, Westville, Durban, 3630, South Africa.
authors.forename: Sarita
authors.initials: S
authors.lastname: Naidoo
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, 123 Jan Hofmeyr Road, Westville, Durban, 3630, South Africa.
authors.forename: Jayajothi
authors.initials: J
authors.lastname: Moodley
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, 123 Jan Hofmeyr Road, Westville, Durban, 3630, South Africa.|Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.|Department of Global Health, School of Medicine, University of Washington, Seattle, USA.
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D015507:Drugs, Investigational / Q000627:therapeutic use*; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000523:psychology*; D006801:Humans; D055118:Medication Adherence; D065129:Pre-Exposure Prophylaxis; D013019:South Africa; D019966:Substance-Related Disorders / Q000523:psychology*; D000068698:Tenofovir / Q000627:therapeutic use*; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D015507:Drugs, Investigational; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D014622:Vaginal Creams, Foams, and Jellies; D000068698:Tenofovir
keywords: HIV prevention; Pill count; Pre-exposure prophylaxis; Product sharing; VOICE