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

HIV Infection Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05947266
• Other study ID #: NIMH34133481
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 66
• Est. completion date: June 30, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection Primary
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Care Resource, Inc.	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Viral suppression	Change in HIV load measurement toward a target of less than 200 copies/ml	Baseline, 6-month post-baseline follow up