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ENTRUST - Economic Navigation and Strengthening to Realize Unrestricted Services for Transgender Women

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Contents

clinicaltrials.gov/study/NCT06667713
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT066677130
Health Conditions in Trial
HIV
HIV
0
Trial Recruitment Size
1200
Trial Sponsor
University of Central Florida
University of Central Florida
0
Clinical Trial Start Date
November 1, 2024
0
Primary Completion Date
April 1, 2026
0
Study Completion Date
April 1, 2027
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Behavioral0
Interventional Trial Phase
Not Applicable0
Participating Facility
University of Central Florida
University of Central Florida
0
Official Name
ENTRUST - Economic Navigation and Strengthening to Realize Unrestricted Services for Transgender Women0
Last Updated
October 31, 2024
0
Allocation Type
Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
SBIRT-T only0
ENTRUST - substance use and HIV counseling and goal setting with economic empowerment and photovoice training0
Study summary

Transgender women in Florida are economically disadvantaged and at highest risk for substance use disorders, HIV transmission and/or non-adherence to antiretroviral treatment, yet remain underrepresented in research. Existing programs fail to address structural barriers such as socio-economic status and social marginalization that deter access to prevention services and care. For this study, acceptability, feasibility, and preliminary efficacy of ENTRUST (economic navigation and strengthening to realize unrestricted services for transgender women) will be assessed. ENTRUST is an economic-based empowerment intervention that will provide transgender women with group-based financial education while receiving tailored SBIRT counseling to help transgender women routinely engaging in substance use services and HIV care or preexposure prophylaxis (PrEP) programs. Participants will be assigned to either the ENTRUST intervention arm or a waitlist control arm. Participants in the intervention arm will receive the ENTRUST intervention during 6-month follow up, and participants assigned to the control arm will have the option of receiving the ENTRUST intervention at the end of the study. Participants in the intervention arm must complete about half of the visits in person, and participants in the control arm will have the option of completing the study visits remotely or in person. All participants will be followed for six months and will complete 4 - 15 study visits. In person site visits will occur at one of our participating sites in Orlando or Miami and will be conducted in English and/or Spanish only. Participants must be adults (over the age) and residing in South or Central Florida. Participants can be enrolled in the study for 6 - 8 months.

Timeline

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