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

NCT05947266 | Recruiting

• 1 other identifier: NIMH34133481
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infection Primary

Keywords

Viral suppression

Outcome Measures

Primary Outcomes (2)

• Care of Engagement Index Score

  Change in Engagement in Care score over time, including comfort and communication with provider

  Baseline, post-intervention (week 12 to 14 post baseline), 6-month post-baseline follow up

• Viral suppression

  Change in HIV load measurement toward a target of less than 200 copies/ml

  Baseline, 6-month post-baseline follow up

Study Arms (1)

Haitian immigrant iENGAGE (H-iENGAGE) intervention

EXPERIMENTAL

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

Behavioral: an adaptation of the iENGAGE

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.

Also known as: Haitian immigrant iENGAGE (H-iENGAGE)

Haitian immigrant iENGAGE (H-iENGAGE) intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Seropositive for HIV
• Either a recent HIV diagnosis (within the last 2 months) or non-virally suppressed.
• Migrated to the US from Haiti

You may not qualify if:

• \. Virally suppressed

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Care Resource, Inc.

Miami, Florida, 33137, United States

RECRUITING

Central Study Contacts

MICHELE JEAN-GILLES, PHD

CONTACT

561-536-4186; gillesm@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, quasi-experimental, single arm study

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 17, 2023
• Study Start: June 3, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)