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AIDS and Behavior

, Volume 20, Issue 11, pp 2654–2661 | Cite as

Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

  • Barbara S. MenschEmail author
  • Elizabeth R. Brown
  • Karen Liu
  • Jeanne Marrazzo
  • Zvavahera Mike Chirenje
  • Kailazarid Gomez
  • Jeanna Piper
  • Karen Patterson
  • Ariane van der Straten
Original Paper

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.

Keywords

Microbicide trials Self-reports of adherence sub-Saharan Africa 

Notes

Acknowledgments

We thank the study participants as well as the VOICE Study team members who implemented the trial. We also thank Elizabeth Montgomery for comments on an earlier draft.

Funding

The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Barbara S. Mensch
    • 1
    Email author
  • Elizabeth R. Brown
    • 2
    • 3
  • Karen Liu
    • 3
  • Jeanne Marrazzo
    • 2
  • Zvavahera Mike Chirenje
    • 4
  • Kailazarid Gomez
    • 5
  • Jeanna Piper
    • 6
  • Karen Patterson
    • 3
  • Ariane van der Straten
    • 7
  1. 1.Population CouncilNew YorkUSA
  2. 2.University of WashingtonSeattleUSA
  3. 3.SCHARP-FHCRCSeattleUSA
  4. 4.UZ-UCSF Collaborative Research ProgrammeHarareZimbabwe
  5. 5.FHI360DurhamUSA
  6. 6.National Institute of Allergy and Infectious Diseases/DAIDSRockvilleUSA
  7. 7.Women’s Global Health ImperativeRTI InternationalSan FranciscoUSA

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