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

NCT03286504 | Completed Results DMC

• 2 other identifiers: 1504016098R01HD091935
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a randomized controlled trial of Group Care in the GHESKIO Community Center versus Individual Care in the GHESKIO Adolescent Clinic for 160 HIV-infected adolescent girls age 16-23 years in Haiti (80 adolescents per arm). Group Care includes receiving integrated clinical and social support services in groups of 5-8 adolescents at a monthly visit. The primary outcome is retention in HIV care at 12 months after randomization.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 12 Month Retention

  Retention in care at 12 months will be measured. 12 month retention is defined as being alive at 12 months and having a care visit between 9 and 15 months after enrollment.

  12 months

Secondary Outcomes (7)

• 12 Month Viral Suppression

  12 months

• Time to Antiretroviral Therapy (ART) Initiation

  12 months

• Optimal Antiretroviral Therapy (ART) Adherence

  12 months

• Sexual Risk Behavior

  12 months

• Number of Sexually Transmitted Infections

  12 months

Study Arms (2)

Standard-of-care

NO INTERVENTION

Adolescents randomized to the standard arm will receive monthly HIV care in the GHESKIO Adolescent Clinic. Clinical care is provided in an individual exam room by a nurse. The patient is sequentially referred to the laboratory, social worker, and pharmacy for medication refills. A typical visit, including wait time, lasts 3 hours.

FANMI - Cohort Care

EXPERIMENTAL

Adolescents randomized to FANMI will receive all monthly HIV care in the community room of the Prince Albert School in Village of God. Adolescents will be grouped in cohorts of 5-10 peers. The entire visit will take \~ 2 hours.

Behavioral: FANMI - Cohort Care

Interventions

FANMI - Cohort Care BEHAVIORAL

FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.

FANMI - Cohort Care

Eligibility Criteria

• Age: 16 Years - 23 Years
• Gender Eligibility Details: The HIV epidemic in Haiti disproportionally affects adolescent girls age 16-23. Our study involves recruitment and enrollment of adolescent girls to determine if our intervention is effective in retaining HIV-infected adolescent girls in Haiti.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female
• Age 16-23 years
• ART naive, initiated ART in the past 3 months, or defaulted from care for 3 months or more
• Participant knowledge of HIV-infection
• Willing to receive care at the clinic or in the community
• Willing to provide consent (age 18 -23 years) or assent with parental/guardian consent (16-17 years)

You may not qualify if:

• Pregnancy at the time of enrollment
• A severe HIV/AIDS illness requiring hospitalization or intensive medical follow-up
• Based on the primary clinician's judgement that the adolescent is at a developmental stage not suited for study participation

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

GHESKIO

Port-au-Prince, Haiti

Location

Related Publications (1)

• Seo G, Joseph JMB, Confident N, Jean E, Louis B, Bell T, Riche RC, Belizaire ME, Rouzier V, Apollon A, Reif L, Rivera V, Abrams E, Bang H, Schackman B, Fitzgerald D, Pape JW, McNairy ML. 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. BMC Public Health. 2019 Dec 30;19(1):1749. doi: 10.1186/s12889-019-8065-6.

  PMID: 31888569 DERIVED

Results Point of Contact

• Title: Dr. Daniel Fitzgerald
• Organization: Weill Cornell Medicine

dwf2001@med.cornell.edu

646-962-8140

Study Officials

• Daniel Fitzgerald, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 18, 2017
• Study Start: May 25, 2018
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2023
• Last Updated: November 7, 2023
• Results First Posted: June 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

HA (1)