AIDS and Behavior

, Volume 18, Issue 5, pp 811–819 | Cite as

Adherence in the CAPRISA 004 Tenofovir Gel Microbicide Trial

  • Leila Essop Mansoor
  • Quarraisha Abdool Karim
  • Nonhlanhla Yende-Zuma
  • Kathleen M. MacQueen
  • Cheryl Baxter
  • Bernadette T. Madlala
  • Anneke Grobler
  • Salim S. Abdool Karim
Original Paper

Abstract

High adherence is key to microbicide effectiveness. Here we provide a description of adherence interventions and the adherence rates achieved in the CAPRISA 004 Tenofovir gel trial. Adherence support for the before-and-after dosing strategy (BAT 24) was provided at enrolment and at each monthly study visit. This initially comprised individual counselling and was replaced midway by a structured theory-based adherence support program (ASP) based on motivational interviewing. The 889 women were followed for an average of 18 months and attended a total of 17,031 monthly visits. On average women reported five sex acts and returned 5.9 empty applicators per month. The adherence rate based on applicator count in relation to all reported sex acts was 72.2 % compared to the 82.0 % self-reported adherence during the last sex act. Adherence support activities, which achieve levels of adherence similar to or better than those achieved by the CAPRISA 004 ASP, will be critical to the success of future microbicide trials.

Keywords

Adherence Adherence support Adherence measures Microbicides Clinical trial HIV prevention 

References

  1. 1.
    UNAIDS. Global report: UNAIDS report on the global AIDS epidemic 2012. Available from: Global report: UNAIDS report on the global AIDS epidemic 2012. Geneva: Joint United Nations Programme on HIV/AIDS2012. Accessed 25 Mar 2013.Google Scholar
  2. 2.
    Van Damme L, Ramjee G, Alary M, et al. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial. Lancet. 2002;360(9338):971–7.PubMedCrossRefGoogle Scholar
  3. 3.
    Feldblum PJ, Adeiga A, Bakare R, et al. SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria. PLoS One. 2008;3:e1474.PubMedCentralPubMedCrossRefGoogle Scholar
  4. 4.
    Peterson L, Nanda K, Opoku BK, et al. SAVVY(R) (C31G) gel for prevention of HIV infection in women: a phase 3, double-blind, randomized, placebo-controlled trial in Ghana. PLoS One. 2007;2(12):e1312.PubMedCentralPubMedCrossRefGoogle Scholar
  5. 5.
    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.PubMedCrossRefGoogle Scholar
  6. 6.
    Halpern V, Ogunsola F, Obunge O, et al. Effectiveness of cellulose sulfate vaginal gel for the prevention of HIV infection: results of a phase III trial in Nigeria. PLoS One. 2008;3:e3784.PubMedCentralPubMedCrossRefGoogle Scholar
  7. 7.
    Van Damme L, Govinden R, Mirembe FM, et al. Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission. N Engl J Med. 2008;359:463–72.PubMedCrossRefGoogle Scholar
  8. 8.
    Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168–74.PubMedCentralPubMedCrossRefGoogle Scholar
  9. 9.
    Tolley EE, Harrison PF, Goetghebeur E, et al. Adherence and its measurement in phase 2/3 microbicide trials. AIDS Behav. 2010;14(5):1124–36.Google Scholar
  10. 10.
    Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367:411–22.PubMedCentralPubMedCrossRefGoogle Scholar
  11. 11.
    Marrazzo J, Ramjee G, Nair G, et al., editors. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir/emtricitabine, or vaginal tenofovir gel in the VOICE study (MTN 003). Conference of Retroviral and Opportunistic Infections; 2013. Goergia World Congress Centre, Atlanta.Google Scholar
  12. 12.
    Reid SE, Reid CA, Vermund SH. Antiretroviral therapy in sub-Saharan Africa: adherence lessons from tuberculosis and leprosy. Int J STD AIDS. 2004;15(11):713–6.PubMedCrossRefGoogle Scholar
  13. 13.
    Lagakos S, Gable A, editors. Methodological challenges in biomedical HIV prevention trials. Washington, DC: National Academies Press; 2008.Google Scholar
  14. 14.
    Gilead Sciences Inc. Investigators Brochure: tenofovir gel (GS-1278). 5th ed. Foster City: California Gilead Sciences; 2013.Google Scholar
  15. 15.
    Mayer KH, Maslankowski LA, Gai F, et al. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006;20(4):543–51.PubMedCrossRefGoogle Scholar
  16. 16.
    Abdool Karim SS, Abdool Karim Q. Diverse approaches useful for microbicide trials. Nature. 2007;449(7158):24.PubMedCrossRefGoogle Scholar
  17. 17.
    Fisher JD, Fisher WA, Rivet Amico K, et al. An information–motivation–behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006;25(4):462–73.PubMedCrossRefGoogle Scholar
  18. 18.
    Fisher JD, Fisher WA. The information–motivation–behavioural skills model. In: DiClemente RJ, Crosby RA, Kegler MC, editors. Emerging theories in health promotion practice and research. Jossey-Bass: San Francisco; 2002. p. 40–70.Google Scholar
  19. 19.
    Misovich S, Fisher J, Martinez T, et al. Predicting breast self-examination: a test of the information–motivation–behavioural skills model. J Appl Psychol. 2003;33:775.Google Scholar
  20. 20.
    Misovich S, Fisher J, Fisher W. Close relationships and HIV risk behaviour: evidence and possible underlying psychological processes. Gen Psychol Rev. 1997;1:72–107.CrossRefGoogle Scholar
  21. 21.
    Carey MP, Carey KB, Weinhardt LS, et al. Behavioral risk for HIV infection among adults with a severe and persistent mental illness: patterns and psychological antecedents. Community Ment Health J. 1997;33(2):133–42.PubMedCentralPubMedCrossRefGoogle Scholar
  22. 22.
    Amico KR, Toro-Alfonso J, Fisher JD. An empirical test of the information, motivation and behavioral skills model of antiretroviral therapy adherence. AIDS Care. 2005;17(6):661–73.PubMedCrossRefGoogle Scholar
  23. 23.
    Mannheimer SB, Morse E, Matts JP, et al. Sustained benefit from a long-term antiretroviral adherence intervention. Results of a large randomized clinical trial. J Acquir Immune Defic Syndr. 2006;43(Suppl 1):S41–7.PubMedCrossRefGoogle Scholar
  24. 24.
    Ferrer RA, Morrow KM, Fisher WA, et al. Toward an information–motivation–behavioral skills model of microbicide adherence in clinical trials. AIDS Care. 2010;22(8):997–1005.PubMedCrossRefGoogle Scholar
  25. 25.
    Fisher JD, Cornman DH, Norton WE, et al. Involving behavioral scientists, health care providers, and HIV-infected patients as collaborators in theory-based HIV prevention and antiretroviral adherence interventions. J Acquir Immune Defic Syndr. 2006;43(Suppl 1):S10–7.PubMedCrossRefGoogle Scholar
  26. 26.
    Rollnick S, Miller WR. What is motivational interviewing? Behav Cogn Psychother. 1995;23:325–34.CrossRefGoogle Scholar
  27. 27.
    Emmons KM, Rollnick S. Motivational interviewing in health care settings. Opportunities and limitations. Am J Prev Med. 2001;20(1):68–74.PubMedCrossRefGoogle Scholar
  28. 28.
    Mansoor LE, Abdool Karim Q, Werner L, et al. Impact of an adherence intervention on the effectiveness of tenofovir gel in the CAPRISA 004 trial. AIDS Behav. 2014. doi:10.1007/s10461-014-0752-9.
  29. 29.
    Mauck CK, Van de Straten A. Using objective markers to assess participant behavior in HIV prevention trials of vaginal microbicides. J Acquir Immune Defic Syndr. 1999;2008(49):64–9.Google Scholar
  30. 30.
    Austin MN, Rabe LK, Hillier SL. Limitations of the dye-based method for determining vaginal applicator use in microbicide trials. Sex Transm Dis. 2009;36(6):368–71.PubMedCentralPubMedCrossRefGoogle Scholar
  31. 31.
    Wallace AR, Teitelbaum A, Wan L, et al. Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials. Contraception. 2007;76(1):53–6.PubMedCrossRefGoogle Scholar
  32. 32.
    Mngadi KT, Maarschalk S, Grobler AC, et al. Disclosure of microbicide gel use to sexual partners: influence on adherence in the CAPRISA 004 trial. AIDS Behav. 2014. doi:10.1007/s10461-014-0696-0.
  33. 33.
    Woodsong C, MacQueen K, Amico KR, et al. Microbicide clinical trial adherence: insights for introduction. J Int AIDS Soc. 2013;16:18505.PubMedCentralPubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Leila Essop Mansoor
    • 1
  • Quarraisha Abdool Karim
    • 1
  • Nonhlanhla Yende-Zuma
    • 1
  • Kathleen M. MacQueen
    • 1
  • Cheryl Baxter
    • 1
  • Bernadette T. Madlala
    • 1
  • Anneke Grobler
    • 1
  • Salim S. Abdool Karim
    • 1
  1. 1.Centre for the AIDS Programme of Research in South Africa, 2nd Floor, Doris Duke Medical Research Institute, Nelson R Mandela School of MedicineUniversity of KwaZulu-NatalCongellaSouth Africa

Personalised recommendations