FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti

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Abstract: Sexually active HIV-infected adolescent girls are an extremely vulnerable and underserved population. If treated promptly with antiretroviral therapy (ART) and retained in care, individuals have a near normal life expectancy. Further, ART will decrease vertical and sexual HIV transmission in a population who are sexually active, have high rates of pregnancy and multiple seronegative partners. However, in Haiti and other resource poor countries, HIV-infected adolescents are three times more likely to be lost from care than adults, with only approximately 50% of HIV-infected teens remaining in care at one year. We have developed FANMI (My Family), an innovative model to improve HIV care for adolescent girls. HIV- infected girls age 16-19 years attend monthly HIV care in cohorts of 5-8 peers. All HIV care takes place in a community center rather than in a medical clinic. Each monthly visit integrates clinical care, peer group counseling, and social activities in a single session by the same provider to simplify care and strengthen the relationships between peers and providers. Preliminary data from our pilot study suggest dramatic improvements in retention with 91% of girls remaining in care at one year. Primary Aim: To conduct a randomized controlled trial at the GHESKIO Center in Port au Prince, Haiti. We will randomize 160 HIV-infected girls age 16-19 years (80 per arm) to FANMI versus standard of care with the primary study endpoint being alive and in care at 12 months. We will have >80% power to detect an improvement in retention at 12 months from 60% in the standard group to 85% in FANMI. Secondary Aims: To compare FANMI versus standard care on the following outcomes: a. Plasma HIV-1 RNA < 1000 copies/µl at 12 months. We predict that 30% of participants in the standard arm will have a suppressed viral load at 12 months compared to 60% in the FAMNI arm due to improved retention, increased visit attendance, and improved ART adherence. b. Sexual risk behavior: self-reported sexual activity, condom use, incidence of sexually-transmitted infections, and pregnancy rate over 12 months. c. Acceptability: We will conduct in-depth interviews to evaluate FANMI and factors associated with retention. d. Health care utilization and costs of FANMI versus standard care. FANMI has the potential to dramatically improve HIV-infected adolescent treatment outcomes across the HIV care cascade and serve as a model of adolescent HIV care in Haiti and other resource-poor countries.