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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04275310
Other study ID # HM20011245
Secondary ID R34MH115775
Status Terminated
Phase N/A
First received
Last updated
Start date July 20, 2022
Est. completion date November 17, 2022

Study information

Verified date August 2023
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to learn more about the economic situations, discrimination experiences, and risk behaviors of transgender women. The ultimate purpose of the study is to test an intervention to improve financial conditions and reduce HIV risk behaviors in transgender women.


Description:

The study includes a microeconomic intervention which will provide education on a variety of economic and behavioral topics. Participants will complete questionnaires on multiple occasions during the study.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date November 17, 2022
Est. primary completion date November 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Transgender woman - 18-45 years of age At least one of the following economic vulnerability factors: unemployment or underemployment [less than 20 hours/week], low income [less than the Medicaid poverty threshold], housing insecurity in the past year or food insecurity in the past year • Behavioral vulnerability to HIV transmission (reported at least one episode of unprotected sex in prior 6 months or at least one other behavioral HIV transmission risk factor in the past 6 months: [transactional sex, multiple sexual partners, 1-time sexual partner, sex under the influence of drugs or alcohol, sex with partner of unknown HIV status). Exclusion Criteria: - obvious signs of intoxication or cognitive impairment - cannot speak English.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Microeconomic Intervention
The intervention will consist of six sessions on six different days. Sessions will be held at VCU or at one of VCU's community partners. Each session will last for around 2 ½ hours (around 15 hours total). There will be breaks and food will be provided. During the sessions the facilitators will provide education on a variety of topics, including economic services that are available to people living in Richmond, job skills (such as creating a resume and dealing with discrimination at work), personal finance education, gender transition ideas, and HIV prevention. The sessions will occur in a group of about 4-10 transgender women.

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Employment Status Number of participants whose status with respect to employment improves after the intervention. Baseline to up to 9 months
Primary Change in Income Number of participants whose income increases after the intervention. Baseline to up to 9 months
Primary Change in Housing Stability Number of participants whose access to stable permanent housing improves after the intervention. Baseline to up to 9 months
Primary Change in Savings Number of participants whose savings increase after the intervention. Baseline to up to 9 months
Primary Change in Self Reported HIV Risk Behavior Number of participants whose self-reports of behaviors known to increase risk for HIV goes down after the intervention. Baseline to up to 9 months
Primary Change in Compliance With Recommended Biomedical Prevention or Treatment Number of participants who demonstrate higher compliance with recommended biomedical prevention or treatment behaviors after the intervention. Baseline to up to 9 months
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