title: Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants' Explanations for Dishonesty.
abstract: Consistent over-reporting of product use limits researchers' ability to accurately measure adherence and estimate product efficacy in HIV prevention trials. While lying is a universal characteristic of the human condition, growing evidence of a stark discrepancy between self-reported product use and biologic or pharmacokinetic evidence demands examination of the reasons research participants frequently misrepresent product use in order to mitigate this challenge in future research. This study (VOICE-D) was an ancillary post-trial study of the vaginal and oral interventions to control the epidemic (VOICE) phase IIb trial (MTN 003). It was conducted in three African countries to elicit candid accounts from former VOICE trial participants about why actual product use was lower than reported. In total 171 participants were enrolled between December 2012 and March 2014 in South Africa (n = 47), Uganda (n = 59) and Zimbabwe (n = 65). Data suggested that participants understood the importance of daily product use and honest reporting, yet acknowledged that research participants typically lie. Participants cited multiple reasons for misreporting adherence, including human nature, self-presentation with study staff, fear of repercussions (study termination resulting in loss of benefits and experience of HIV-related stigma), a permissive environment in which it was easy to get away with misreporting, and avoiding inconvenient additional counseling. Some participants also reported mistrust of the staff and reciprocal dishonesty about the study products. Many suggested real-time blood-monitoring during trials would encourage greater fidelity to product use and honesty in reporting. Participants at all sites understood the importance of daily product use and honesty, while also acknowledging widespread misreporting of product use. Narratives of dishonesty may suggest a wider social context of hiding products from partners and distrust about research, influenced by rumors circulating in clinic waiting-rooms and surrounding communities. Prevailing power hierarchies between staff and participants may exacerbate misreporting. Participants recognized and suggested that objective, real-time feedback is needed to encourage honest reporting.
authors.affiliation: Women's Global Health Imperative, RTI International, 351 California St, Suite 500, San Francisco, CA, 94104, USA. emontgomery@rti.org.
authors.forename: Elizabeth T
authors.initials: ET
authors.lastname: Montgomery
authors.affiliation: Population Council, New York, NY, USA.
authors.forename: B
authors.initials: B
authors.lastname: Mensch
authors.affiliation: UZ-UCSF Collaborative Research Programme, Harare, Zimbabwe.
authors.forename: P
authors.initials: P
authors.lastname: Musara
authors.affiliation: Women's Global Health Imperative, RTI International, 351 California St, Suite 500, San Francisco, CA, 94104, USA.
authors.forename: M
authors.initials: M
authors.lastname: Hartmann
authors.affiliation: HIV Prevention Research Unit, South Africa Medical Research Council, Durban, South Africa.
authors.forename: K
authors.initials: K
authors.lastname: Woeber
authors.affiliation: Johns Hopkins University Research Unit, Makerere University, Kampala, Uganda.
authors.forename: J
authors.initials: J
authors.lastname: Etima
authors.affiliation: Women's Global Health Imperative, RTI International, 351 California St, Suite 500, San Francisco, CA, 94104, USA.|Center for AIDS Prevention Studies, Department of Medicine, UCSF, Mission Bay, San Francisco, CA, 94105, USA.
authors.forename: A
authors.initials: A
authors.lastname: van der Straten
mesh_terms: D000282:Administration, Intravaginal; D000284:Administration, Oral; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D008192:Deception; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination / Q000627:therapeutic use*; D058872:Epidemics; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D055118:Medication Adherence; D036301:Qualitative Research; D057566:Self Report; D012747:Sexual Partners / Q000523:psychology; D013019:South Africa / Q000453:epidemiology; D000068698:Tenofovir / Q000627:therapeutic use*; D014454:Uganda / Q000453:epidemiology; D055815:Young Adult; D015030:Zimbabwe / Q000453:epidemiology
chemical_list: D019380:Anti-HIV Agents; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D000068698:Tenofovir
keywords: Adherence; Africa; HIV prevention; Honesty; Women