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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Infection Primary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Care Resource, Inc.

Miami, Florida, 33137, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Virally suppressed

Treatment and study plan

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.

Other names: Haitian immigrant iENGAGE (H-iENGAGE)

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Jul 17, 2023
Registry last updated: Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting