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

NCT ID: NCT05947266

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2026-06-30

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.

Detailed Description

Research design: The proposed study will test a culturally tailored engagement and retention intervention for Haitian immigrants living with HIV (HILWH). This is sequential mixed-methods formative pilot research that is designed to examine engagement and retention in care, and viral suppression (VS) for HILWH and adapt a promising intervention that will result in viral suppression between baseline and a 6 month follow-up assessment. The pilot will be conducted as a prospective, quasi-experimental single arm with a sample of newly diagnosed or nonvirally suppressed HIWLH adults drawn from 2 Federally Qualified Health Centers (FQHC) sites in Miami.

Procedures to be used:

AIM 1 mixed methods (quantitative and qualitative) data collection on barriers and facilitators to viral suppression among HILWH. Quantitative questionnaires will be completed by health care service providers and HILWH who will also participate in a Focus group. A sample of HILWH will participate in individual in-depth interviews.

AIM 2 consists of a pilot health intervention entailing completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment. In addition, participants will have 4 individual meetings, approximately once monthly over a six month period.

AIM 3 Photovoice participants will be 6 participants who have completed the pilot intervention (AIM 2) and agree to 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 taking photographs. This activity is expected to take approximately 8 additional hours over 2 and a half months. For these six participants, the total amount of time will be approximately 20 hours over 8 and 1/2 months.

Conditions

HIV Infection Primary

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

an adaptation of the iENGAGE

Intervention Type: 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.

Interventions

an adaptation of the iENGAGE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Haitian immigrant iENGAGE (H-iENGAGE)

Eligibility Criteria

Inclusion Criteria

1. Seropositive for HIV

2. Either a recent HIV diagnosis (within the last 2 months) or non-virally suppressed.

3. Migrated to the US from Haiti

Exclusion Criteria

1. Virally suppressed

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Care Resource, Inc.

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

MICHELE JEAN-GILLES, PHD

Role: CONTACT

gillesm@fiu.edu

561-536-4186

Facility Contacts

MICHELE JEAN-GILLES, PhD

Role: primary

gillesm@fiu.edu

561-536-4186

Other Identifiers

NIMH34133481

Identifier Type: -

Identifier Source: org_study_id