P13.05
Background: Sex workers in Durban, South Africa are at high risk for HIV infection and would benefit from effective prevention technologies. A small urban sex worker cohort participated in the CAPRISA 004 trial and their demographics, trial outcomes and adherence estimates have not been exclusively described previously.
Methods: We conducted a retrospective analysis of demographic data, sexual frequency, gel applicator use and assessed adherence using applicator returns in conjunction with behavioural data from the CAPRISA 004 trial sex worker cohort.
Results: In total 18 eligible female sex workers (self-identified) were enrolled (two ineligible women were excluded from this analysis). At baseline median (IQR) age was 22 years (IQR: 20-27) and 27.8% completed high school. At enrolment, approximately 77.8% reported condom use at last sex act, and 61.1% reported having a stable partner. Eleven participants were randomized to the placebo arm and 7 to the active arm. Overall, median trial participation duration was 21 months (IQR: 11-28 months). Median sex acts reported per month was 10 (IQR: 7 to 13.5) and median number of applicators dispensed per month was 13 (IQR: 10-20). Of these 60% (IQR: 40-93%) of applicators were returned as used. Adherence, based on returned used applicators and self-reported sex, was 50% (IQR: 45-100) overall. HIV incidence was 7.53 per 100PY (95% CI 0.9 - 27.2). However, there were only two HIV infections, both being in the placebo arm and HIV incidence in that arm was 13.8 per 100PY (95%CI 1.7 - 49.8). This is in contrast to the HIV incidence rate in the parent trial which was 9.1 per 100PY (95%CI 6.9-11.7) in the placebo arm.
Conclusions: Despite their high risk for HIV infection the small CAPRISA 004 sex worker cohort demonstrated moderate adherence to study gel. However, it is noteworthy that the active arm had 100% protection and that the sex workers had higher adherence to this coital gel regimen compared to women prescribed daily gel in the VOICE trial in South Africa
