MTN-003-P01 was a observational pilot study to assess the feasibility, acceptability and performance of an Electronic Event-based Monitoring System (Wisebag). The objectives of the study were based on the assumption that the “active” Wisebags will: 1) successfully and accurately record opening events; 2) will be acceptable for use by women in the study; 3) women will not be able to distinguish between an active and dummy Wisebag.
It is widely accepted that self-reporting of adherence yields inaccurate results, most often inflation, of product use. Adherence, however, is one of the most important components of testing whether or not a study product is effective. The Wisebag™ is a lunch bag-style container with an electronic events-monitoring system. This opening event-monitoring bag is a promising technology that could provide objective measures of the days and times that women retrieve gel applicators for use. However, the functionality of Wisebag when used daily and in “offline” mode had never been tested, and required piloting prior to its use in larger-scale studies. The MTN-003-P01 study results were first presented at the Microbicides 2012 Conference. The primary manuscript was published in AIDS and Behavior in February 2013.
US National Institute of Mental Health
US National Institutes of Health