title: Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?
abstract: VOICE-a phase 2B, placebo-controlled, randomized trial testing daily use of an antiretroviral tablet (tenofovir or Truvada) or daily use of tenofovir gel in 5029 women from South Africa, Uganda, and Zimbabwe-found none of the drug regimens effective in reducing HIV-1 acquisition in the intent-to-treat analysis. More than half of women assigned to active products in a case cohort sample had no drug detected in any plasma specimens tested during the trial. Yet, in response to questions asked of participants during the trial, ≥90 % of doses were reportedly taken. To explore factors associated with low adherence, a behavioral termination visit questionnaire was developed after early closure of the oral tenofovir and vaginal gel arms. We hypothesized that participants would be more forthcoming about nonuse after they exited the trial than during monthly/quarterly follow-up visits. Comparison of adherence reporting at routine follow-up visits with reporting at trial termination, however, indicates that disclosure of product nonadherence did not increase at the termination visit as anticipated. In resource-limited settings where women value the ancillary benefits provided by trial participation and are concerned that disclosure of nonuse may jeopardize trial participation, objective measures of adherence may yield more meaningful data regarding the inability or reluctance to use than measures of product use derived from self-report.
authors.affiliation: Population Council, One Dag Hammarskjold Plaza, New York, NY, 10017, USA. bmensch@popcouncil.org.
authors.forename: Barbara S
authors.initials: BS
authors.lastname: Mensch
authors.affiliation: University of Washington, Seattle, WA, USA.|SCHARP-FHCRC, Seattle, WA, USA.
authors.forename: Elizabeth R
authors.initials: ER
authors.lastname: Brown
authors.affiliation: SCHARP-FHCRC, Seattle, WA, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Liu
authors.affiliation: University of Washington, Seattle, WA, USA.
authors.forename: Jeanne
authors.initials: J
authors.lastname: Marrazzo
authors.affiliation: UZ-UCSF Collaborative Research Programme, Harare, Zimbabwe.
authors.forename: Zvavahera Mike
authors.initials: ZM
authors.lastname: Chirenje
authors.affiliation: FHI360, Durham, NC, USA.
authors.forename: Kailazarid
authors.initials: K
authors.lastname: Gomez
authors.affiliation: National Institute of Allergy and Infectious Diseases/DAIDS, Rockville, MD, USA.
authors.forename: Jeanna
authors.initials: J
authors.lastname: Piper
authors.affiliation: SCHARP-FHCRC, Seattle, WA, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Patterson
authors.affiliation: Women's Global Health Imperative, RTI International, San Francisco, CA, USA.
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D008192:Deception; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination / Q000008:administration & dosage* / Q000493:pharmacokinetics; D005260:Female; D005782:Gels; D015658:HIV Infections / Q000097:blood / Q000517:prevention & control*; D006801:Humans; D055118:Medication Adherence / Q000523:psychology*; D008875:Middle Aged; D065129:Pre-Exposure Prophylaxis; D012650:Self Disclosure; D013019:South Africa; D000068698:Tenofovir / Q000008:administration & dosage* / Q000493:pharmacokinetics; D014454:Uganda; D055815:Young Adult; D015030:Zimbabwe
chemical_list: D019380:Anti-HIV Agents; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D005782:Gels; D000068698:Tenofovir
keywords: Microbicide trials; Self-reports of adherence; sub-Saharan Africa