Monitoring Microbicide Gel Use with Real-Time Notification of the Container’s Opening Events: Results of the CAPRISA Wisebag Study
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Accurate estimation of the effectiveness of a microbicide for HIV prevention requires valid measurement of adherence to product use. A microbicide gel applicator container (Wisebag), fitted with cell phone technology to transmit opening events and text message reminders, was developed to monitor each opening event of the container as a proxy for gel use and adherence. Ten women were enrolled in a pilot study and followed for up to 4 months. Wisebag opening (WBO) dates and times were recorded and correlated with self-reported sex acts and gel applicator returns. During the 33 monthly follow-up visits, 47.8 % (77/161) of the recorded number of WBO events were concordant with the number of empty (used) applicators returned. The discrepancies were likely due to removal of more than one applicator during a single opening event. When the date and time of the WBO event data was assessed in relation to three different self-report adherence measures, agreement was fairly modest. The Wisebag was found to be acceptable as a storage container and the cell phone reminders generated were useful in supporting the dosing strategy. We recommend that the Wisebag be considered for larger scale and lengthier testing in microbicide trials.
KeywordsAdherence Electronic monitoring Microbicides Clinical trials HIV prevention
We thank Kershani Naidoo, Bernadene Moodley, Cynthia Velile Ngcobo, Bhavna Maharaj, Nolwazi Thandiwe Nzimande, Londeka Zondi and Gugulethu Masinga for conducting the informed consent and acceptability interviews. The CAPRISA Wisebag is manufactured by Wisepill Technologies (www.wisepill.com) and the CAPRISA Wisebag study was sponsored by Lifelab. Lloyd Marshall’s support and development of the prototype bags is acknowledged. Precious Sikhakane assisted with CRF development and data oversight of the Wisebag study. The CAPRISA 004 Tenofovir Gel trial is supported by the Centre for the AIDS Program of Research in South Africa (CAPRISA), the United States Agency for International Development (USAID), Family Health International (FHI) (cooperative agreement # GPO-A-00-05-00022-00, contract # 132119), and LIFElab, a biotechnology center of the South African Department of Science and Technology. Support from CONRAD for the product manufacturing and packaging as well as support from Gilead Sciences for the Tenofovir used in the production of gel is gratefully acknowledged. We thank the US National Institutes for Health’s Comprehensive International Program of Research on AIDS (CIPRA Grant # AI51794) and the Columbia University-Southern African Fogarty AIDS International Training and Research Programme (AITRP Grant # D43TW00231) for the research infrastructure and training that made this trial possible.
Conflict of interest
All authors report no conflicts of interest.
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