Background: Oral pre-exposure prophylaxis (PrEP) is a component of comprehensive HIV prevention. Clinical trials with incident HIV as a principal study outcome have an ethical imperative to offer state-of-the-art HIV prevention options.
Methods: ECHO, an open-label clinical trial of HIV incidence compared across women randomized to three effective contraceptive methods (DMPA-IM, copper IUD, and LNG implant), followed 7829 HIV-negative sexually active women aged 16-35 years from 12 sites in 4 African countries (Kenya, Eswatini, South Africa, and Zambia) for up to 18 months from December 2015 through October 2018. The trial protocol permitted PrEP use. During ECHO, national policies and guidelines evolved to recommend PrEP for persons with HIV risk, and access to PrEP was prioritized by the trial team, either off-site via referral or on-site via trained trial staff.
Results: PrEP access in ECHO began in Kenya in May 2017 and was available at all sites by June 2018. Of the 3626 (46.3% of trial total) women in follow-up when PrEP became available, 622 (17.2%) initiated PrEP. PrEP initiation did not differ across study arms (p=0.7). Women initiating PrEP were slightly older, more likely to be unmarried, not living with their partner, having multiple partners, not earning their own income, not receiving financial support from partners, and have higher rates of Chlamydia trachomatis (all p-values < 0.05 by chi-square tests). The median duration of use was 85 days (IQR 39-96) prior to study exit; two-thirds received a 3-month PrEP refill at study exit. Among women with access to PrEP during the trial, there were 37 HIV seroconversions among women who did not initiate PrEP and 2 among women who initiated PrEP (HIV incidence 2.4 versus 1.0 per 100 person-years, IRR 0.35, 95% CI 0.04-1.38). Of these two women, one who became HIV infected had discontinued PrEP two months prior to HIV seroconversion.
Conclusions: PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial was feasible. PrEP was taken up by 17.2% of participants and included those with characteristics suggesting higher HIV risk.