Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes

Part of paid clinical trials in Miami, Florida.

Sponsor
Florida International University
Study ID
NCT05947266
Status
Recruiting

Conditions

  • HIV Infection Primary

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • an adaptation of the iENGAGE — BEHAVIORAL
    Haitian immigrant iENGAGE (H-iENGAGE) is an adaptation of the iENGAGE intervention culturally adapted for Haitian immigrants with HIV that will be tested in a quasi-experimental pilot for preliminary efficacy among recently diagnosed or nonvirally suppressed adults across two Federally Qualified Health Centers (FQHCs) in Miami.

Study Details

The goal of this clinical trial is to test a culturally tailored engagement and retention intervention for Haitian Immigrants Living With HIV (HILWH). The main questions it aims to answer are: * Does this intervention result in measurable engagement and retention in care? * Does this intervention result in measurable viral suppression within 6 months? Participants will * participate in a pilot health intervention entailing 4 individual meetings, approximately once monthly over a six-month period and completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment. * Six participants who have completed the pilot intervention and agree to take part, will participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and take and display photographs.

Key Dates

Start date
Jun 3, 2024
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Haitian immigrant iENGAGE (H-iENGAGE) intervention
    1. Enrollment; 2. Baseline assessment; 3. Upon baseline completion, scheduling of H-iENGAGE sessions 1 through 4 4. Following Session 4, conduct Process evaluation; 5. Post-intervention assessment; 6. Six-month follow up assessment\* \*Six participants will complete AIM 3: Identify multi-level implementation factors contributing to intervention outcomes, using photovoice in mixed methods. 7. End of study participation

Primary Outcome Measure

Care of Engagement Index Score [ Time Frame: Baseline, post-intervention (week 12 to 14 post baseline), 6-month post-baseline follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Care Resource, Inc.MiamiFlorida33137
MICHELE JEAN-GILLES, PhD
561-536-4186

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