FANMI ("My Family"): A Randomized Trial of Community Cohort Care for Adolescent Girls and Young Women Living with HIV in Haiti.

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.