Skip to main content

Advertisement

SpringerLink
Log in

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

  • Report
  • Published:
AIDS and Behavior Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

References

  1. 2008 Report on the global AIDS epidemic. “Status of the global HIV epidemic.” Geneva: Joint United Nations Programme on HIV/AIDS (UNAIDS), 2008. Available at: http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/2008/2008_Global_report.asp.

  2. Padian NS, van der Straten A, Ramjee G, et al. Diaphragm and lubricant gel of prevention of HIV acquisition in southern African women: a randomized controlled trial. Lancet. 2007;13:251–61.

    Article  Google Scholar 

  3. Watson-Jones D, Weiss HA, Rusizoka M, et al. Effect of herpes simplex suppression on incidence of HIV among women in Tanzania. N Engl J Med. 2008;368:1560–71.

    Article  Google Scholar 

  4. Skoler-Karpoff S, Ramjee G, Ahmed K, et al. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372(9654):1977–87.

    Article  PubMed  CAS  Google Scholar 

  5. Chesney MA. The elusive gold standard: future perspectives for HIV adherence assessment and intervention. J Acquir Immune Defic Syndr. 2006;43(S1):S149–55.

    PubMed  Google Scholar 

  6. Lagakos SW, Gable AR, editors. Design considerations: adherence. In: Methodological challenges in biomedical HIV prevention trials. Washington, DC: National Academies Press; 2008. p. 5.1–5.24.

  7. Celum C, Wald A, Hughes J, et al. Effect of acyclovir on HIV-1 acquisition in herpes simplex virus 2 seropositive women and men who have sex with men: a randomized, double-blind, placebo-controlled trial. Lancet. 2008;371:2109–19.

    Article  PubMed  CAS  Google Scholar 

  8. Gupta R, Wald A, Krantz E, et al. Valacyclovir and acyclovir for suppression of shedding of herpes simplex virus in the genital tract. J Infect Dis. 2004;190:1374–81.

    Article  PubMed  CAS  Google Scholar 

  9. Weiss HA, Wasserheit JN, Barnabas RV, Hayes RJ, Abu-Raddad LJ. Persisting with prevention: the importance of adherence for HIV prevention. Emerg Themes Epidemiol. 2008;5(8):1–7.

    Google Scholar 

  10. Plummer ML, Watson-Jones D, Lees S, et al. A qualitative study of participant adherence in a randomized controlled trial of herpes suppressive therapy for HIV prevention in Tanzania. AIDS Care. 2010;22(4):499–508.

    Article  PubMed  Google Scholar 

Download references

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.

Author information

Authors and Affiliations

  1. Department of Medicine, University of Washington, Seattle, WA, USA

    Shevin T. Jacob, Jared M. Baeten, Anna Wald & Connie Celum

  2. Department of Global Health, University of Washington, Harborview Medical Center, Box 359927, 325 Ninth Avenue, 98104, Seattle, WA, USA

    Jared M. Baeten & Connie Celum

  3. Department of Biostatistics, University of Washington, Seattle, USA

    James P. Hughes

  4. Asociación Civil Impacta Salud y Educación, Lima, Peru

    Jesús Peinado & Jorge Sanchez

  5. Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    Shevin T. Jacob, Jing Wang & Anna Wald

  6. Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA

    Stewart E. Reid

  7. Centre for Infectious Disease Research in Zambia, Lusaka, Zambia

    Stewart E. Reid

  8. Wits Institute for Sexual Health, HIV and Related Diseases, University of the Witwatersrand, Johannesburg, South Africa

    Sinead Delany-Moretlwe

  9. Centre for Sexual Health and HIV Research, University College London, London, UK

    Frances Cowan

  10. Department of Community Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe

    Frances Cowan

  11. San Francisco Department of Public Health, San Francisco, CA, USA

    Jonathan D. Fuchs

  12. New York Blood Center, New York, NY, USA

    Beryl Koblin

  13. FHI, Research Triangle Park, NC, USA

    Sam Griffith

Authors
  1. Shevin T. Jacob
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jared M. Baeten
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. James P. Hughes
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jesús Peinado
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Jing Wang
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Jorge Sanchez
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Stewart E. Reid
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Sinead Delany-Moretlwe
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Frances Cowan
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Jonathan D. Fuchs
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Beryl Koblin
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Sam Griffith
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Anna Wald
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Connie Celum
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Connie Celum.

Additional information

This study was conducted for the HPTN 039 Protocol Team.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Jacob, S.T., Baeten, J.M., Hughes, J.P. et al. A Post-Trial Assessment of Factors Influencing Study Drug Adherence in a Randomized Biomedical HIV-1 Prevention Trial. AIDS Behav 15, 897–904 (2011). https://doi.org/10.1007/s10461-010-9853-2

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10461-010-9853-2

Keywords

Search

Navigation