NCT03286504

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

Completed NA Results posted Last updated 7 November 2023

What this trial tests

NA trial testing FANMI - Cohort Care in HIV in 120 participants. Completed in 1 October 2023.

Timeline

25 May 2018

Primary endpoint
1 June 2022

1 October 2023

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	25 May 2018
Primary completion	1 June 2022
Estimated completion	1 October 2023
Sites	1 location across Haiti

Drugs / interventions tested

• FANMI - Cohort Care

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 16 to 23, female only, with HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

12 Month Retention Primary · 12 months

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.

Group	Value	95% CI
Standard-of-care	41
FANMI - Cohort Care	44

12 Month Viral Suppression Secondary · 12 months

Viral suppression at 12 months will be measured. Suppressed viral load will be defined as a binary outcome based upon the WHO definition of viral suppression as a plasma HIV-1 RNA level \<1000 copies/µl.

Group	Value	95% CI
Standard-of-care	26
FANMI - Cohort Care	28

Time to Antiretroviral Therapy (ART) Initiation Secondary · 12 months

Time to ART initiation is the number of calendar days from date of HIV diagnosis to date of ART initiation.

Group	Value	95% CI
Standard-of-care	0	0 – 0
FANMI - Cohort Care	0	0 – 0

Optimal Antiretroviral Therapy (ART) Adherence Secondary · 12 months

ART adherence will be measured by self-report using two questions: 1) number of pills missed in the past 4 days and 2) forgot to take pills last weekend. A response of no missed pills in the past 4 days and did not forget to take pills last weekend is defined as 'optimal' adherence. All other responses are defined as 'sub-optimal' adherence.

Group	Value	95% CI
Standard-of-care	22
FANMI - Cohort Care	18

Sexual Risk Behavior Secondary · 12 months

Sexual risk behavior will be measured by regular condom use among those who are sexually active. Regular condom use is defined as a response of 'often' or 'always' when asked about condom use during sexual intercourse.

Group	Value	95% CI
Standard-of-care	21
FANMI - Cohort Care	26

Number of Sexually Transmitted Infections Secondary · 12 months

Sexually Transmitted Infections will include syphilis, diagnosed using a serum RPR (HUMAN) followed by a treponemal test if positive (Bioline Standard Diagnostics), chlamydia and gonorrhea, diagnosed by the urine GeneXpert GT/NG assay.

Group	Value	95% CI
Standard-of-care	10
FANMI - Cohort Care	20

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antiretroviral adherence for adolescents growing up with HIV: understanding real life, drug delivery and forgiveness.
   Foster C, Ayers S, Fidler S. · · 2020 · cited 30× · PMID 32523693 · DOI 10.1177/2049936120920177
2. "FANMI": A Promising Differentiated Model of HIV Care for Adolescents in Haiti.
   Reif LK, Rivera VR, Bertrand R, Belizaire ME, et al · · 2019 · cited 12× · PMID 31107305 · DOI 10.1097/qai.0000000000002088
3. 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.
   Seo G, Joseph JMB, Confident N, Jean E, et al · · 2019 · cited 5× · PMID 31888569 · DOI 10.1186/s12889-019-8065-6