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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05947266
Enrollment
66
Registered
2023-07-17
Start date
2024-06-03
Completion date
2027-05-31
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection Primary

Keywords

Viral suppression

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.

Interventions

BEHAVIORALan 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.

Sponsors

Florida International University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective, quasi-experimental, single arm study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Care of Engagement Index ScoreBaseline, post-intervention (week 12 to 14 post baseline), 6-month post-baseline follow upChange in Engagement in Care score over time, including comfort and communication with provider
Viral suppressionBaseline, 6-month post-baseline follow upChange in HIV load measurement toward a target of less than 200 copies/ml

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026