Participant adherence to gel use instructions regarding timing for gel insertion and for vaginal cleansing in the MDP 301 microbicides trial in Johannesburg.
Background: PRO 2000/5, a microbicide gel currently in a Phase III trial, is delivered vaginally via an applicator which must be inserted within one hour before a sex act. Vaginal cleansing should occur at least one hour after the sex act. Adherence to rigid timelines may be problematic and therefore impact on the long term success of the product. Methods: To determine ability to adhere to gel use instructions for timing of insertion before a sex act and vaginal cleansing afterwards, reported sex acts where gel was used in Johannesburg were assessed. Information collected on case record forms at specified time points was used to determine the factors that influenced gel use. Results were analysed using STATA. Results: Of 13829 reported sex acts protected by gel, timing for insertion was mostly correct: 96.94%, CI (95.16-96.19). Vaginal cleansing was reported for 52.57% (51.74-53.40) of sex acts where gel was used; among these timing was correct for 78.65% (77.69-79.59) of observations. Analysis at each time point showed a trend for increasing correct gel use (p value
Poster from Microbicides 2008, New Delhi, India, 24-27 February 2008.