Microbicide Trials Network

MTN-003-P01

Details

Protocol Title: 
The Wisebag Observational Pilot Study: Feasibility, Acceptability and Performance of an Electronic Event-based Monitoring System (Wisebag)
DAIDS Protocol ID: 
11835
Status: 
Participants off Study and Primary Analysis Completed

Protocol Chair(s)

Ariane van der Straten (Protocol Chair)

Description

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.

Other Study Info

Sponsored by:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US National Institute of Mental Health

US National Institutes of Health