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

NCT06667713 | Terminated

• 2 other identifiers: University of Central FloridaDP2DA058436
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Use Disorder (SUD); HIV

Keywords

economic strengthening; substance use; HIV; Florida

Outcome Measures

Primary Outcomes (2)

• Number of people engaging and being retained in substance use and HIV services

  Engagement will be measured by self-report of at least one visit to a substance use treatment center/\[HIV\] provider during 6 month follow up A participant will be considered retained in care if they complete more than one treatment to the facility during 6 month follow up The number of visits will be reported for each facility by outcome (substance use or HIV prevention/treatment)

  6 months

• Number of people linking to other support services other than substance use or HIV services

  Engagement will be measured by self-report of at least one visit to a bank or other similar financial entity/mental health/housing/legal service during 6 month follow up A participant will be considered retained in care if they complete more than one treatment to a facility during 6 month follow up The number of visits will be reported for each facility by outcome

  6 months

Secondary Outcomes (2)

• Substance Use Disorder Diagnosis

  Any time during 6 months of follow up

• HIV diagnosis

  Any time during 6 months of follow up

Study Arms (2)

Intervention

EXPERIMENTAL

ENTRUST intervention comprised of adapted SBIRT-T, economic strengthening and photovoice training

Behavioral: ENTRUST - substance use and HIV counseling and goal setting with economic empowerment and photovoice training

Waitlist Control

ACTIVE COMPARATOR

SBIRT-T only

Behavioral: SBIRT-T only

Interventions

ENTRUST - substance use and HIV counseling and goal setting with economic empowerment and photovoice training BEHAVIORAL

The ENTRUST intervention consists of an adapted counseling intervention based on motivational interviewing techniques and goal setting (SBIRT-T); Economic skill building using a tailored app (WorthIt for ENTRUST); and, Photovoice Activities with an optional photo exhibit

Intervention

SBIRT-T only BEHAVIORAL

An adapted screening brief intervention and referral to treatment intervention to link transgender women to substance use and HIV services

Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender women assigned male at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Economically vulnerable adult transgender women at risk for SUD and/or HIV who speak English or Spanish and live in South or Central Florida

You may not qualify if:

• Minor transgender women who do not speak English or Spanish and can not attend visits in South or Central Florida

Sponsors & Collaborators

• University of Central Florida: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Central Florida

Orlando, Florida, 32827, United States

Location

Related Publications (5)

• Thoele K, Moffat L, Konicek S, Lam-Chi M, Newkirk E, Fulton J, Newhouse R. Strategies to promote the implementation of Screening, Brief Intervention, and Referral to Treatment (SBIRT) in healthcare settings: a scoping review. Subst Abuse Treat Prev Policy. 2021 May 11;16(1):42. doi: 10.1186/s13011-021-00380-z.

  PMID: 33975614 BACKGROUND

• Bray JW, Del Boca FK, McRee BG, Hayashi SW, Babor TF. Screening, Brief Intervention and Referral to Treatment (SBIRT): rationale, program overview and cross-site evaluation. Addiction. 2017 Feb;112 Suppl 2:3-11. doi: 10.1111/add.13676.

  PMID: 28074566 BACKGROUND

• Singh M, Gmyrek A, Hernandez A, Damon D, Hayashi S. Sustaining Screening, Brief Intervention and Referral to Treatment (SBIRT) services in health-care settings. Addiction. 2017 Feb;112 Suppl 2:92-100. doi: 10.1111/add.13654.

  PMID: 28074565 BACKGROUND

• Cyrus E, Johnson SA, Perez-Gilbe HR, Wuyke G, Fajardo FJ, Garba NA, Devieux J, Jimenez D, Garcia S, Holder CL. Engagement in Care and Housing Instability Influence HIV Screening Among Transgender Individuals in South Florida. Transgend Health. 2022 Feb 14;7(1):52-60. doi: 10.1089/trgh.2020.0066. eCollection 2022 Feb.

  PMID: 35224190 BACKGROUND

• Holder CL, Perez-Gilbe HR, Fajardo FJ, Garcia S, Cyrus E. Disparities of HIV risk and PrEP use among transgender women of color in South Florida. J Natl Med Assoc. 2019 Dec;111(6):625-632. doi: 10.1016/j.jnma.2019.08.001. Epub 2019 Sep 13.

  PMID: 31526532 BACKGROUND

Related Links

• Link to adapted HRC app for ENTRUST economic strengthening

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Randomized Controlled Trial (RCT)

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 31, 2024
• Study Start: November 1, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

US (1)