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 — BEHAVIORALHaitian 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) intervention1. 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
- MICHELE JEAN-GILLES, PHD561-536-4186
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Care Resource, Inc. | Miami | Florida | 33137 |
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