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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2022
• Main ID: NCT03286504
• Date of registration: 13/09/2017
• Prospective Registration: Yes
• Primary sponsor: Weill Medical College of Cornell University
• Public title: FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti
• Scientific title: FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti
• Date of first enrolment: May 25, 2018
• Target sample size: 121
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03286504
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Haiti

Contacts

• Name: Daniel Fitzgerald, MD
• Affiliation: Weill Medical College of Cornell University

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: 23 Years
Gender: Female

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Behavioral: FANMI - Cohort Care

Primary Outcome(s)

12 month retention [Time Frame: 12 months]

Secondary Outcome(s)

Healthcare utilization [Time Frame: 12 months]

Sexually transmitted infections [Time Frame: 12 months]

ART adherence [Time Frame: 12 months]

Sexual risk behavior [Time Frame: 12 months]

Time to ART initiation [Time Frame: 12 months]

Acceptability [Time Frame: 12 months]

12 month viral suppression [Time Frame: 12 months]

Secondary ID(s)

R01HD091935

1504016098

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

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