ABSTRACT
To unpack the factors that influence microbicide adherence within and beyond clinical trials, we explore the relationship between individual adherence, the clinical trial context, and the socio-cultural and healthcare settings within which clinical trials are embedded. As some have argued, microbicides, as well as other self-administered biomedical prevention strategies, are better understood as bio-behavioral strategies [3-4]. In adopting a bio-behavioral perspective, factors contextualizing the relationship between a product under study and the person, communities, and systems surrounding its use can be more clearly articulated [5-7]. Ultimately, these factors will exert a strong influence over uptake, use, and community level effects on preventing HIV infection.First-generation vaginal microbicides were broad-spectrum with potential activity against HIV and other sexually transmitted infections (STIs). They included the over-the-counter spermicide, nonoxynol-9 (N-9), as well as novel compounds with spermicidal and antiviral properties, including SAVVY®, Buffergel, ACIDFORM, PRO 2000, cellulose sulfate (CS) and Carraguard [8]. While these first microbicide clinical trials collected adherence data-mainly through diaries, brief self-reported questions, and/or applicator counts [9-10], they relied largely on the randomized clinical trial design and measurement of HIV outcomes to determine product effectiveness.1 Because these products were not systemically absorbed, biomarkers of adherence, such as drug levels in blood, were non-existent.Lacking biomarkers of adherence, some trials sought to improve adherence measures by altering the time reference for reported adherence (i.e., use at last sex or over the last week) or triangulating data from several different adherence measures [9].
