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AIDS and Behavior

, Volume 15, Issue 5, pp 897–904 | Cite as

A Post-Trial Assessment of Factors Influencing Study Drug Adherence in a Randomized Biomedical HIV-1 Prevention Trial

  • Shevin T. Jacob
  • Jared M. Baeten
  • James P. Hughes
  • Jesús Peinado
  • Jing Wang
  • Jorge Sanchez
  • Stewart E. Reid
  • Sinead Delany-Moretlwe
  • Frances Cowan
  • Jonathan D. Fuchs
  • Beryl Koblin
  • Sam Griffith
  • Anna Wald
  • Connie Celum
Report

Abstract

High adherence and maintenance of blinding are critical for placebo-controlled efficacy trials of HIV-1 biomedical prevention strategies. We assessed adherence to study drug and factors affecting adherence, including perceived randomization group, in a post-trial questionnaire of participants who completed HPTN 039, a randomized, placebo-controlled trial of HSV-2 suppression with twice-daily acyclovir to reduce HIV-1 acquisition. Of the 3172 trial participants, 2003 (63%) completed the post-trial questionnaire. Of these 2003, 72% reported missing a dose of study drug less than twice a week. Study drug adherence was not compromised by perceived randomization or genital ulcer symptoms during the study. Alcohol use was cited as an adherence barrier in some populations. Assessment of study drug adherence during and at the end of trials can evaluate perceptions of randomization and adherence by randomization arm, help to better understand barriers to and motivations for adherence, and develop interventions to increase adherence for future trials.

Keywords

Adherence Biomedical prevention HIV-1 Clinical trials 

Notes

Acknowledgments

We thank the HPTN 039 study participants, HPTN 039 site staff, and Scott Rose of Family Health International for their dedication and significant contributions. This study was supported through the US National Institutes of Health through funding to the University of Washington (U01 AI52054 and K24 AI 071113) and by the HIV Prevention Trials Network (HPTN) under Cooperative Agreement U01 AI46749 and U01 AI068619, sponsored by the National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, National Institute of Drug Abuse, National Institute of Mental Health, and Office of AIDS Research.

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Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Shevin T. Jacob
    • 1
    • 5
  • Jared M. Baeten
    • 1
    • 2
  • James P. Hughes
    • 3
  • Jesús Peinado
    • 4
  • Jing Wang
    • 5
  • Jorge Sanchez
    • 4
  • Stewart E. Reid
    • 6
    • 7
  • Sinead Delany-Moretlwe
    • 8
  • Frances Cowan
    • 9
    • 10
  • Jonathan D. Fuchs
    • 11
  • Beryl Koblin
    • 12
  • Sam Griffith
    • 13
  • Anna Wald
    • 1
    • 5
  • Connie Celum
    • 1
    • 2
  1. 1.Department of MedicineUniversity of WashingtonSeattleUSA
  2. 2.Department of Global HealthUniversity of Washington, Harborview Medical CenterSeattleUSA
  3. 3.Department of BiostatisticsUniversity of WashingtonSeattleUSA
  4. 4.Asociación Civil Impacta Salud y EducaciónLimaPeru
  5. 5.Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research CenterSeattleUSA
  6. 6.Department of MedicineUniversity of Alabama at BirminghamBirminghamUSA
  7. 7.Centre for Infectious Disease Research in ZambiaLusakaZambia
  8. 8.Wits Institute for Sexual Health, HIV and Related DiseasesUniversity of the WitwatersrandJohannesburgSouth Africa
  9. 9.Centre for Sexual Health and HIV ResearchUniversity College LondonLondonUK
  10. 10.Department of Community MedicineUniversity of Zimbabwe College of Health SciencesHarareZimbabwe
  11. 11.San Francisco Department of Public HealthSan FranciscoUSA
  12. 12.New York Blood CenterNew YorkUSA
  13. 13.FHIResearch Triangle ParkUSA

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