Fanmi: A Randomized Trial of Community Cohort Hiv Care for Adolescent Girls, Haiti

ABSTRACT

Background: Adolescent girls and young women are the epicenter of the global HIV epidemic and in need of multilevel interventions to improve their health outcomes. Method(s) FANMI, a randomized-controlled trial, evaluated the effectiveness of community-based cohort HIV care versus standard of care (SOC) among adolescent and young adults living with HIV (AYALH) in Haiti. Females, 16-24 years who were newly diagnosed with HIV at clinic or community HIV testing sites, or defaulted >6 months from care, were randomized 11 to FANMI vs SOC. FANMI was designed to improve convenience, social support and stigma by grouping AYALH in cohorts of 6-10 peers to attend monthly HIV care sessions in a community center with integrated clinical care, group counseling, and social activities led by the same provider. National guideline changes during the study included switching participants to dolutegravir regimens and expanding SOC visits to 6 months. The primary outcome was 12-month retention defined as any visit 9-15 months from enrollment. Secondary outcomes included viral suppression (< 1000 copies/ml), risk behaviors, and acceptability using interviews. Result(s) 120 AYALH enrolled (60 per arm) between May 2018-January 2021. Median age was 21, 91% were newly diagnosed, and median CD4 count was 591 cells/mm3 (IQR 399-788). A total of 78.3% (47/60) FANMI participants vs 85.0% (51/60) in SOC achieved the primary outcome (unadjusted RR=0.92 95%CI 0.78-1.09, p=0.35). Excluding 9 participants who never attended a FANMI/SOC visit after enrollment, 12-month retention was 88.7% (47/53) in FANMI vs 87.9% (51/58) in SOC (RR =1.01 95%CI 0.88-1.15, p=0.90). Participants who presented for HIV testing vs community testing and achieved the primary outcome: 95% vs 70% (FANMI) and 83% vs 88% (SOC). Viral suppression among those retained at 12 months 44.6% (21/47) in FANMI and 37.3% (19/51) in SOC (RR 1.20 95% CI 0.74-1.9, p=0.45). There were no differences in pregnancy and risk behaviors. Providers preferred FANMI reporting increased time for counseling and peer support. FANMI participants reported high acceptability, decreased stigma, and increased social support with no confidentiality breaches. Limitations included interrupted study operations during the COVID-19 pandemic. Conclusion(s) FANMI was not more effective for AYALH in Haiti but was preferred by providers and highly acceptable to participants. It offers promise as a complementary program for high-risk AYALH in low-income settings facing barriers to clinic-based care.