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

NCT03286504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-11-07

Study results available
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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

Interventions

BEHAVIORAL

FANMI - Cohort Care

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.

Sponsors & Collaborators

  • Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Daniel Fitzgerald, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
23 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2022-06-01
Completion
2023-10-01

Countries

  • Haiti

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03286504 on ClinicalTrials.gov