Adherence in the CAPRISA 004 tenofovir gel microbicide trial.
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Date
2014
Journal Title
Journal ISSN
Volume Title
Publisher
Springer.
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
17031 monthly visits. On average women reported 5 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.
Description
CAPRISA, 2014.
Keywords
Adherence., Adherence support., Adherence measures., Microbicides., Clinical trial., HIV prevention.
Citation
Mansoor, L.E., Abdool Karim, Q., Yende-Zuma, N., MacQueen, K.M., Baxter, C., Madlala, B.T., Grobler, A. and Abdool Karim, S.S. 2014. Adherence in the CAPRISA 004 tenofovir gel microbicide trial. AIDS and Behavior 18(5), 811-819.