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

Primary Purpose

HIV Infection Primary

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
an adaptation of the iENGAGE
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection Primary focused on measuring Viral suppression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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: 1. Virally suppressed

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Haitian immigrant iENGAGE (H-iENGAGE) intervention

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Care of Engagement Index Score
    Change in Engagement in Care score over time, including comfort and communication with provider
    Viral suppression
    Change in HIV load measurement toward a target of less than 200 copies/ml

    Secondary Outcome Measures

    Full Information

    First Posted
    June 26, 2023
    Last Updated
    August 7, 2023
    Sponsor
    Florida International University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05947266
    Brief Title
    Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes
    Official Title
    Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    June 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Florida International University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infection Primary
    Keywords
    Viral suppression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective, quasi-experimental, single arm study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Haitian immigrant iENGAGE (H-iENGAGE) intervention
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    an adaptation of the iENGAGE
    Other Intervention Name(s)
    Haitian immigrant iENGAGE (H-iENGAGE)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Care of Engagement Index Score
    Description
    Change in Engagement in Care score over time, including comfort and communication with provider
    Time Frame
    Baseline, post-intervention (week 12 to 14 post baseline), 6-month post-baseline follow up
    Title
    Viral suppression
    Description
    Change in HIV load measurement toward a target of less than 200 copies/ml
    Time Frame
    Baseline, 6-month post-baseline follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 1. Virally suppressed
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MICHELE JEAN-GILLES, PHD
    Phone
    561-536-4186
    Email
    gillesm@fiu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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