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

January 21, 2026 updated by: Florida International University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MICHELE JEAN-GILLES, PhD
  • Phone Number: 561-536-4186
  • Email: gillesm@fiu.edu

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33137
        • Recruiting
        • Care Resource, Inc.
        • Contact:
          • MICHELE JEAN-GILLES, PhD
          • Phone Number: 561-536-4186
          • Email: gillesm@fiu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: 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.
Other Names:
  • Haitian immigrant iENGAGE (H-iENGAGE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Care of Engagement Index Score
Time Frame: Baseline, post-intervention (week 12 to 14 post baseline), 6-month post-baseline follow up
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
Time Frame: Baseline, 6-month post-baseline follow up
Change in HIV load measurement toward a target of less than 200 copies/ml
Baseline, 6-month post-baseline follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIMH34133481

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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