MTN-003-P01

Primary Objectives

• Compare the on-site technical performance of the “offline” and “online” functionalities of Wisebag
• Assess the success of attempted blinding of the “dummy” vs. active (“online” or “offline”) Wisebag
• Measure the concordance between Wisebag opening-event data (both “online” and “offline”) and self-reported data
• Explore the feasibility and acceptability of Wisebag use by participants

Study Summary
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 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.

MTN-003-P01 was a three-arm, randomized, placebo-controlled, double-blinded pilot study of Wisebag for monitoring daily product use. Fifty participants were randomized to the 3 study arms in a 1:2:2 ratio. The 3 groups were “dummy” Wisebag, “Online device” Wisebag, or “Offline device” Wisebag. There were two study visits: an enrollment visit and one follow-up/exit visit, two weeks after enrollment. Participants were asked to open their assigned Wisebag at approximately the same specified time daily, to peel off one sticker from a set of study stickers inside the bag and place the sticker on the appropriate day of the week on a study provided diary card. After two weeks of daily openings, participants were asked to return to the study clinic for an exit visit with their Wisebag and diary card.

MTN-003-P01 completed follow-up on September 23, 2011. Results were first presented at the Microbicides Conference held on April 15-18, 2012, in Sydney, Australia. The primary manuscript, the only paper from this study, was published in AIDS and Behavior in February 2013.

Primary Results
In the two-week pilot study, women found the bags acceptable for use. Blinding between the different WB/device types (online/offline/dummy) was successful. Agreement between Wisebag opening data and clinic-based observation was high. During home use, however, moderate concordance was found between Wisebag opening data and the diary card. Adherence reporting was higher by self-report (diary card or CRF at study exit) compared to Wisebag. Many participants reported protocol non-adherence, including non-use and over-use of the Wisebag.