Measurement of vaginal microbicide adherence using visual inspection as compared to ultra violet light assessment of returned empty gel applicators.

Master of Science in Pharmacy. University of KwaZulu-Natal, Durban 2015.Introduction Finding a safe, effective and acceptable HIV prevention method is key to preventing new infections in women. Vaginal microbicide trials aim to do so, but adherence to study product remains a challenge in interpretation of study product effectiveness. Accurate and objective measures of adherence are critical in microbicide trials. Methods We compared two applicator tests, visual inspection of returned empty applicators (VIREA) and ultraviolet (UV) light assessment of empty applicators returned as used within a tenofovir (TFV) gel implementation trial. Sensitivity and specificity in a small pilot sample was assessed at two time points, approximately three months apart. Reliability and concordance of the techniques was also assessed. Results Sensitivity and specificity analysis of 24 sample applicators at time point 1 was 75.0% and 66.7% for VIREA and 83.3% and 91.7% for UV light assessment, respectively; Sensitivity and specificity at time point 2 was 100% and 58.3% for VIREA and 100% and 66.7% for UV light assessment, respectively. Participants (n=115, median age 28 years) enrolled in the implementation trial at the Vulindlela Research Clinic, returned 1316 empty TFV applicators as used in January 2015. Assessment outcomes showed 78.8% agreement between VIREA and UV light techniques. Methods concurred that 22% of the returned empty applicators did not appear to be used. UV light assessment identified about 28% less product used, as compared to that returned as used by women. Conclusion UV light assessment appears to be a more accurate and less subjective measure of adherence as compared to VIREA. Further studies are needed to verify accuracy of UV light inspection against available DNA/protein biomarkers. UV light assessment can be used in combination with other biomarkers to identify potential challenges to adherence and inform targeted adherence interventions with the intention of optimizing adherence during microbicide clinical trials

Assessing adherence to antiretroviral therapy in a rural paediatric cohort in KwaZulu-Natal, South Africa.

CAPRISA, 2016.Abstract available in pdf

Monitoring microbicide gel use with real-time notification of the container’s opening events : results of the CAPRISA Wisebag study.

CAPRISA, 2014.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

Measuring adherence by visual inspection of returned empty gel applicators in the CAPRISA 004 microbicide trial.

CAPRISA, 2014.Abstract not available in pdf