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

• ClinicalTrials.gov Identifier: NCT05947266
• Recruitment Status: Enrolling by invitation
• First Posted: July 17, 2023
• Sponsor: Florida International University
• Information provided by (Responsible Party): Florida International University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV Infection Primary	Behavioral: an adaptation of the iENGAGE	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 66 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, quasi-experimental, single arm study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes
• Estimated Study Start Date: May 1, 2024
• Estimated Primary Completion Date: December 1, 2025
• Estimated Study Completion Date: June 30, 2026

Arms and Interventions

Arm

Intervention/treatment

Experimental: Haitian immigrant iENGAGE (H-iENGAGE) intervention; Enrollment;; Baseline assessment;; Upon baseline completion, scheduling of H-iENGAGE sessions 1 through 4; Following Session 4, conduct Process evaluation;; Post-intervention assessment;; 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.; 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 Name: Haitian immigrant iENGAGE (H-iENGAGE)

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

Care Resource, Inc.

Miami, Florida, United States, 33137

Sponsors and Collaborators

Florida International University

More Information

• Responsible Party: Florida International University
• ClinicalTrials.gov Identifier: NCT05947266
• Other Study ID Numbers: NIMH34133481
• First Posted: July 17, 2023
• Last Update Posted: May 9, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Florida International University:

Viral suppression

Additional relevant MeSH terms:

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases