Monitoring microbicide gel use with real-time notification of the container's opening events: Results of the CAPRISA wisebag study
Centre for the AIDS Programme of Research in South Africa (CAPRISA), Doris Duke Medical Research Institute (2nd Floor), University of KwaZulu-Natal, 719 Umbilo Road, Durban, South Africa; FHI360, Durham, NC, United States; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, United States
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. © 2014 Springer Science+Business Media New York.
antiinfective agent; gel; adult; coitus; devices; drug delivery system; feasibility study; female; follow up; gel; HIV Infections; human; intravaginal drug administration; medication compliance; mobile phone; pilot study; questionnaire; text messaging; Administration, Intravaginal; Adult; Anti-Infective Agents; Cell Phones; Coitus; Drug Delivery Systems; Feasibility Studies; Female; Follow-Up Studies; Gels; HIV Infections; Humans; Medication Adherence; Pilot Projects; Questionnaires; Text Messaging