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Adherence in the CAPRISA 004 Tenofovir Gel Microbicide Trial

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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.

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Acknowledgments

We pay tribute to the women who participated in this trial; their dedication and commitment made this study possible. The CAPRISA 004 Tenofovir gel trial was supported by the Centre for the AIDS Program of Research in South Africa (CAPRISA), the United States Agency for International Development (USAID), FHI (co-operative agreement # GPO-A-00-05-00022-00, contract # 132119), and the Technology Innovation Agency (formerly known as LIFElab), a biotechnology centre of the South African Department of Science and Technology. Support from CONRAD for the product manufacturing and packaging as well as support from Gilead Sciences for the Tenofovir used in the production of gel is gratefully acknowledged. We thank the US National Institutes for Health’s Comprehensive International Program of Research on AIDS (CIPRA Grant # AI51794) and the Columbia University–Southern African Fogarty AIDS International Training and Research Programme (AITRP Grant # D43TW00231) for the research infrastructure and training that made this trial possible.

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Authors and Affiliations

  1. Centre for the AIDS Programme of Research in South Africa, 2nd Floor, Doris Duke Medical Research Institute, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Private Bag X7, Congella, 4013, South Africa

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

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  1. Leila Essop Mansoor
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  2. Quarraisha Abdool Karim
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  3. Nonhlanhla Yende-Zuma
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  4. Kathleen M. MacQueen
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  5. Cheryl Baxter
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  6. Bernadette T. Madlala
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  7. Anneke Grobler
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  8. Salim S. Abdool Karim
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Correspondence to Leila Essop Mansoor.

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Mansoor, L.E., Abdool Karim, Q., Yende-Zuma, N. et al. Adherence in the CAPRISA 004 Tenofovir Gel Microbicide Trial. AIDS Behav 18, 811–819 (2014). https://doi.org/10.1007/s10461-014-0751-x

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