부산대학교 도서관

BACKGROUND:: HIV endpoint-driven clinical trials provide oral pre-exposure prophylaxis (PrEP) as HIV prevention standard of care. We evaluated quantifiable plasma tenofovir among South African women who used oral PrEP during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial. METHODS:: ECHO, a randomized trial conducted in four African countries between 2015-2018, assessed HIV incidence among HIV-uninfected women, aged 16-35 years, randomized to one of three contraceptives. Oral PrEP was offered onsite as part of the HIV prevention package at the South African trial sites. We measured tenofovir in plasma samples collected at the final trial visit among women reporting ongoing PrEP use. We used univariate and multivariate logistical regression to assess demographic and sexual risk factors associated with plasma tenofovir quantification. RESULTS:: Of 260 women included, 52% were ≤24 years and 22% had Chlamydia trachomatis at enrolment. At PrEP initiation, 68% reported inconsistent/non-use of condoms. The median duration of PrEP use was 90 days (IQR: 83-104). Tenofovir was quantified in 36% (n=94) of samples. Women >24 years had twice the odds of having tenofovir quantified vs younger women (OR=2.12; 95%CI=1.27-3.56). Women who reported inconsistent/non-use of condoms had lower odds of tenofovir quantification (age-adjusted OR=0.47; 95%CI=0.26-0.83). CONCLUSION:: Over a third of women initiating PrEP and reporting ongoing use at the final trial visit had evidence of recent drug exposure. Clinical trials may serve as an entry point for PrEP initiation among women at substantial risk for HIV infection with referral to local facilities for ongoing access at trial end.