Background: Evidence guiding scale-up of pre-exposure prophylaxis (PrEP) in African women is required for implementation of new WHO guidelines. The CAPRISA 008 trial, which provided participants from CAPRISA 004 with post-trial access to tenofovir gel, assessed adherence and effectiveness of PrEP provision integrated into family planning (FP) services.
Methods: CAPRISA 008 was a 36-month, two-arm, open-label, randomized controlled, non-inferiority trial. Eligible women (n=372) were randomly assigned to receive tenofovir gel at clinical trial clinics (n=183) or at FP clinics (n=189). Adherence, retention, HIV incidence and service preference were assessed.
Results: At baseline, women assigned to trial and FP clinics were similar and study retention rates were 92.3% and 92.1% respectively. Adherence (% reported sex acts covered by 2 gel doses) was 73.9% (95% confidence interval (CI): 70.7-77.1) in trial clinics and 79.9% (CI: 76.7-83.2) in FP clinics. Higher adherence (mean difference=6.0% [CI: 1.5-10.6]) in FP clinics met the pre-defined non-inferiority criteria. Mean monthly sex acts and returned empty applicators were 4.5 (CI: 4.0-5.0) and 6.0 (CI: 5.5-6.5) in trial clinics compared to 3.6 (CI: 3.2-4.1) and 5.2 (CI: 4.7-5.7) in FP clinics respectively. Genital tenofovir was detected at one year in 68/156 women (43.6%; CI: 36.1-51.4) at trial clinics and 62/157 women (39.5%; CI: 32.2-47.3) at FP clinics (p=0.492). Adjusting for peri-coital gel use, genital tenofovir was detected in 58.3% of 139 women reporting sex within 7 days but only in 28.2% of 174 women reporting no recent sex. HIV incidence was 3.6 per 100 women years (wy) (CI: 1.9-6.3) in trial clinics and 3.5 per 100 wy (CI: 1.8-6.0) in FP clinics (p=0.928). Overall HIV incidence rate was 44% lower than in an age-comparable historical CAPRISA 004 placebo control group (3.5 vs 6.2 per 100 wy). At study exit 75.1% and 80.3% of women from trial and FP clinics expressed preference for receiving PrEP from FP clinics.
Conclusions: Integration of topical PrEP into FP services for African women is feasible, acceptable and achieves adherence equivalent to a clinical trial setting, providing evidence for PrEP scale-up using this strategy for this challenging high-priority population.