As it is impossible to control for every medication intake/application, patients need to be monitored by more or less crude subjective measurements as a generally accepted "gold standard" does not exist for measuring adherence and persistence.
We discuss the innovative nature of this trial and the challenges related to choice of patient population, maintaining masking, cost effectiveness, ethical considerations, measuring adherence, and placebo development and testing.
Despite their individual merits for measuring adherence and sensitive behaviour, none of these self-assessment techniques are capable of generating in-depth understanding of behaviours or reasons for behaviours.
In what follows we first review the pros and cons of the main methods currently available (or being developed) for measuring adherence and related behaviour in vaginal microbicide and similar studies.
Additionally, trials have differed in methodological factors including sample size, duration of intervention, primary outcome, method of measuring adherence, and follow-up after completion of the DAART intervention.
The coitally-related gel-use message created challenges for measuring adherence and evaluating the potential contribution of behavioral variability to the effectiveness outcome.
