Clinical trial NCT06667713: ENTRUST - Economic Navigation and Strengthening to Realize Unrestricted Services for Transgender Women
Official title: ENTRUST - Economic Navigation and Strengthening to Realize Unrestricted Services for Transgender Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Substance Use Disorder (SUD)
HIV
Keywords: economic strengthening
substance use
HIV
Florida
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-10-31
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized Controlled Trial (RCT)
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of people engaging and being retained in substance use and HIV services
timeFrame: 6 months
measure: Number of people linking to other support services other than substance use or HIV services
timeFrame: 6 months
Secondary outcomes:
measure: Substance Use Disorder Diagnosis
timeFrame: Any time during 6 months of follow up
measure: HIV diagnosis
timeFrame: Any time during 6 months of follow up
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.