N/A
N=120
FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti
HIV
Bottom Line
View on ClinicalTrials.gov: NCT03286504 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: 12 Month Retention — 41; 44 Participants — p=0.55
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FANMI - Cohort Care (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12 Month Retention |
41; 44 | 0.55 |
| SECONDARY 12 Month Viral Suppression |
26; 28 | 0.71 |
| SECONDARY Time to Antiretroviral Therapy (ART) Initiation |
0; 0 | — |
| SECONDARY Optimal Antiretroviral Therapy (ART) Adherence |
22; 18 | 0.65 |
| SECONDARY Sexual Risk Behavior |
21; 26 | 0.04 sig |
| SECONDARY Number of Sexually Transmitted Infections |
10; 20 | 0.03 sig |
| SECONDARY Acceptability |
— | — |
| SECONDARY Healthcare Utilization |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03286504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.