The FANMI ("my FAMILY" in Creole) study to evaluate community-based cohort care for adolescent and young women living with HIV in Haiti: protocol for a randomized controlled trial

Grace Seo, Joseph Marie Bajo Joseph, Nancy Confident, Esther Jean, Bianca Louis, Tatiana Bell, Rose Cardelle Riche, Marie Elmase Belizaire, Vanessa Rouzier, Alexandra Apollon, Lindsey Reif, Vanessa Rivera, Elaine Abrams, Heejung Bang, Bruce Schackman, Daniel Fitzgerald, Jean W Pape, Margaret L McNairy, Grace Seo, Joseph Marie Bajo Joseph, Nancy Confident, Esther Jean, Bianca Louis, Tatiana Bell, Rose Cardelle Riche, Marie Elmase Belizaire, Vanessa Rouzier, Alexandra Apollon, Lindsey Reif, Vanessa Rivera, Elaine Abrams, Heejung Bang, Bruce Schackman, Daniel Fitzgerald, Jean W Pape, Margaret L McNairy

Abstract

Background: Adolescent girls and young women living with HIV in resource-limited settings have the poorest health outcomes of any age group, due in part to poor retention in care. Differentiated models of HIV care that target the specific challenges of young people living with HIV are urgently needed.

Methods: The FANMI study is an unblinded randomized controlled trial designed to evaluate the efficacy of an adolescent-specific model of HIV care in Port-au-Prince, Haiti. The FANMI intervention places newly young women living with HIV who are not currently on ART or on ART ≤ 3 months, in cohorts of 5-10 peers to receive monthly group HIV care in a community location. In contrast, participants in the standard care arm receive routine HIV care and individual counseling each month in GHESKIO's Adolescent Clinic. A total of 160 participants ages 16-23 years old are being randomized on a 1:1 basis. The primary outcome is retention in HIV care defined as being alive and in care at 12 months after enrollment. Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs.

Discussion: The FANMI study evaluates a novel community-based cohort model of HIV care aimed at improving retention in care and reducing risk behaviors for HIV transmission among adolescent girls and young women living with HIV. Specifically, the FANMI model of care addresses social isolation by placing participants in cohorts of 5-10 peers to provide intensified peer support and makes HIV health management a group norm; reduces stigma and improves convenience by providing care in a community setting; and integrates clinical care and social support by the same providers to streamline care and promote long-term patient-provider relationships. If shown to be effective, the FANMI intervention may serve as a model of HIV care for improving retention among hard-to-reach adolescents and young adults in Haiti and could be adapted for other high-risk groups globally.

Trial registration: Identifier: NCT03286504, Registered September 18, 2017.

Conflict of interest statement

This study has been registered under The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Adapted Social Action Theory: Factors Influencing Retention of Adolescent Girls and young Women Living with HIV in Haiti
Fig. 2
Fig. 2
Comparison of the FANMI Model with Standard Care for Adolecent Girls and Young Women Ages 16–23 Living with HIV in Haiti

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