Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DP2DA058436 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Stopped because of executive orders of new administration
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | ENTRUST intervention comprised of adapted SBIRT-T, economic strengthening and photovoice training |
|
| Waitlist Control | Active Comparator | SBIRT-T only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Substance Use Disorder Diagnosis | Per AUDIT and DAST criteria. Higher scores indicate a greater risk of developing an alcohol use (AUDIT) or drug use (DAST) disorder | Any time during 6 months of follow up |
| HIV diagnosis |
Not provided
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
Transgender women assigned male at birth
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Central Florida | Orlando | Florida | 32827 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33975614 | Background | 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. | |
| 28074566 | 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. |
| Label | URL |
|---|---|
| Link to adapted HRC app for ENTRUST economic strengthening | View source |
Not provided
Depending on the sensitivity of the information that may deidentify participants, some variables may not be shared. However, there will be a plan to share deidentified data related to primary and secondary outcomes.
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 29, 2025 | |
| Reset | Oct 14, 2025 | |
| Release | Oct 15, 2025 |
Not provided
Randomized Controlled Trial (RCT)
Not provided
Not provided
Not provided
Not provided
|
| SBIRT-T only | Behavioral | An adapted screening brief intervention and referral to treatment intervention to link transgender women to substance use and HIV services |
|
Measure by rapid oral swab and confirmed by Western Blot Confirmatory test
| Any time during 6 months of follow up |
| 28074565 | 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. |
| 35224190 | 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. |
| 31526532 | 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. |
| Reset | Oct 28, 2025 |
| Release | Oct 31, 2025 |
| Reset | Nov 14, 2025 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 29, 2025 | Oct 14, 2025 | |||
| Oct 15, 2025 | Oct 28, 2025 | |||
| Oct 31, 2025 | Nov 14, 2025 |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided