P23.03
Background: Gel adherence is an issue that plagues microbicide trials. Electronic monitoring devices are thought to provide more detailed and accurate data on study product use.
Methods: In an effort to obtain an assessment of adherence in a randomized, double-blind trial comparing three formulations of 1% tenofovir gel administered rectally, 12 participants received their applicators in a Wisebag™. The Wisebag is a lunch-bag style container which contains a device with a communication chip which transmits a message to a server every time the Wisebag is opened. These stored data were compared to participant report of gel administration as well as applicator (used and unused) counts. Participants were to insert the rectal gel daily for five consecutive days for each of three different formulations.
Results: Participants at both sites indicated on self-report that they administered the five consecutive doses of gel for each of the three formulations. This was also reported by count of used and unused applicators. These reports could not be supported or refuted by the data provided from the Wisebag recordings. The Wisebag data indicated that for all participants the bag was opened more than once on at least one day up to more than once daily for all 5 days. In addition to difficulty interpreting the frequent recorded openings the bags were fraught with technical challenges throughout the trial.
Conclusions: Although the Wisebag may become an important measure of adherence in the future, logistical problems associated with this technology need to be addressed. Although it is understood that there is no way to control the frequency participates open the bag despite counseling, the Wisebag performance fell short of its anticipated usefulness.
