Abstract
Adolescent girls and young women (AGYW) are the epicenter of the global HIV epidemic. The FANMI trial is an unblinded randomized-controlled trial which evaluated the effectiveness of a community-based model of cohort HIV care vs. standard clinic-based care among AGYW living with HIV in Haiti. Participants ages 16-24 years were randomized 1:1 to FANMI vs. standard care. In the FANMI intervention, cohorts of 5-10 participants attended monthly sessions in a community center for integrated HIV clinical care, group counseling, and social activities led by the same provider. The primary outcome was 12-month retention, defined as any visit 9-15 months from study enrollment. Secondary outcomes included viral suppression (< 1000 copies/ml), risk behaviors, and acceptability. 120 AGYW with HIV enrolled (60 per arm) between May 2018 and January 2021. 73% (44/60) in FANMI vs. 68% (41/60) in standard care achieved 12-month retention (RR = 1.07; 95% CI 0.85-1.35). Excluding participants who never returned after enrollment, 83% (38/46) in FANMI vs. 71% (41/58) in standard care (RR = 1.17; 95% CI 0.95-1.45) achieved 12-month retention. 47% (28/60) in FANMI and 43% (26/60) in standard care achieved 12-month viral suppression (p = 0.45). FANMI participants reported high acceptability, decreased stigma, and increased social support. There was no significant difference in 12-month retention between arms. The FANMI intervention was more effective for participants who self-presented to the clinic for HIV testing compared to those tested in a community-based setting. FANMI was highly acceptable to participants and offers promise as a complementary program for AGYW with HIV in low-income settings.