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

Sponsor

Florida International University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05947266

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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	N/A

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

Anticipated Enrollment :

66 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, quasi-experimental, single arm studyProspective, 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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 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 Names: Haitian immigrant iENGAGE (H-iENGAGE)

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 Names:

Haitian immigrant iENGAGE (H-iENGAGE)

Outcome Measures

Primary Outcome Measures

Care of Engagement Index Score [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 [Baseline, 6-month post-baseline follow up]
Decrease in HIV load measurement toward a target of less than 200 copies/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Florida International University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Florida International University

ClinicalTrials.gov Identifier:

NCT05947266

Other Study ID Numbers:

NIMH34133481

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Florida International University

Viral suppression

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Jul 17, 2023