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临床试验/NCT06667713
NCT06667713终止不适用

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

University of Central Florida1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
1
主要终点
Number of people engaging and being retained in substance use and HIV services

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Intervention

Experimental

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

干预措施: ENTRUST - substance use and HIV counseling and goal setting with economic empowerment and photovoice training (Behavioral)

Waitlist Control

Active Comparator

SBIRT-T only

干预措施: SBIRT-T only (Behavioral)

结局指标

主要结局

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

时间窗: 6 months

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)

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

时间窗: 6 months

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

次要结局

  • Substance Use Disorder Diagnosis(Any time during 6 months of follow up)
  • HIV diagnosis(Any time during 6 months of follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Cyrus

Associate Professor of Medicine

University of Central Florida

研究点 (1)

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