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

NCT ID: NCT06667713

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-03-14

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.

Detailed Description

The ENTRUST intervention is adaptive based on participant's substance use, HIV status and economic status. Participants in both arms will receive an adapted tailored screening, brief intervention and referral to treatment intervention for transgender women (SBIRT-T) to set personal goals around linking to substance use services, HIV care and linking to financial institutions. As indicated participants may also receive support with mental health services, housing and legal services. Any participant who receives the ENTRUST intervention will also participate in group-based economic empowerment and skill building training, and photovoice training. Photovoice is a process where participants take pictures of their daily lives while they are in the study to help document their experience. The economic empowerment training will be completed using a tailored app developed by the Human Rights Campaign for this Study (WorthIt for ENTRUST) over four sessions. The photovoice training will be facilitated by an ENTRUST facilitator at one of the participating collaborating sites in Orlando or Miami. At the end of the four photovoice sessions, participants may volunteer to do a public exhibit presenting study images from the photovoice activities to key stakeholders to initiate a call to action around policy to impact change that improves transgender women linking to substance use services and HIV care and improving their financial health.

Conditions

Substance Use Disorder (SUD); HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Waitlist Control

SBIRT-T only

Group Type: ACTIVE_COMPARATOR

SBIRT-T only

Intervention Type: BEHAVIORAL

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

Interventions

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

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 Type: BEHAVIORAL

SBIRT-T only

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Central Florida

OTHER

Sponsor Role: lead

Responsible Party

Elena Cyrus

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Central Florida

Orlando, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 33975614 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28074566 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28074565 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35224190 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31526532 (View on PubMed)

Related Links

https://worthitforentrust.hrc.org/

Link to adapted HRC app for ENTRUST economic strengthening

Other Identifiers

DP2DA058436

Identifier Type: NIH

Identifier Source: secondary_id

View Link

University of Central Florida

Identifier Type: -

Identifier Source: org_study_id