Background: Background: Adolescent girls and young women (AGYW) are likely to benefit from PrEP. Strategies to support PrEP uptake and address barriers to consistent use are urgently needed. We conducted a randomised controlled trial to evaluate whether empowerment clubs increase PrEP uptake and continuation among AGYW.
Methods: Methods: We enrolled sexually active, HIV-negative women into an open-label PrEP study. Participants were randomised to standard of care (SOC), which included comprehensive sexual and reproductive health care, with counselling and SMS reminders for PrEP users, or to empowerment clubs plus SOC. A standardised four-session curriculum developed to support safe introduction of PrEP within relationships was delivered at monthly facilitator-led, small group sessions. Clinic follow-up visits were scheduled at months 1, 3 and quarterly thereafter, for up to 15 months. We used pharmacy records to measure PrEP continuation. We assessed differences in PrEP continuation using Kaplan-Meier survival analysis, by log-rank test.
Results: Results: From October 2016 to July 2017, 619 women were screened, 431 women enrolled (SA n=379, Tz n=52) and 213 randomised to clubs. Participants were mostly unmarried (90%), 27% had >1 partner in the past 6 months, 39% used a condom at last sex and 33% had a curable STI; most (84%) believed PrEP could prevent HIV. Of these, 408 initiated PrEP at, and 8 after, enrolment (97%) (SA n=364, Tz n=52). Participants completed a median of 3 follow up visits (range 0-6) and one club session (range 0-7); 48% did not attend any club sessions. In the ITT, PrEP continuation did not vary significantly by study arm (p-value =0.31); PrEP continuation was 73% at M1, 61% at M3 and 34% at M6 (Figure 1). There was also no difference in PrEP continuation when comparing those that attend ≥1 club session compared to none (p-value =0.12).
Conclusions: Conclusions: While PrEP uptake was high in this at-risk population, use diminished with time. Empowerment club participation was low and did not enhance PrEP continuation, contrary to experiences in the HIV treatment field. Ongoing analyses will elucidate barriers to club participation and reasons for PrEP discontinuation and inform the development of future tailored PrEP support packages for adolescents.



[Figure 1]