Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women

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.

Study Overview

• Status: Terminated
• Conditions: Hiv; Transgenderism
• Intervention / Treatment: Behavioral: Microeconomic Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Benotsch, PhD; Phone Number: 8048280133; Email: ebenotsch@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microeconomic 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.
No Intervention: Waitlisted control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Employment Status	Number of participants whose status with respect to employment improves after the intervention.	Baseline to up to 9 months
Change in Income	Number of participants whose income increases after the intervention.	Baseline to up to 9 months
Change in Housing Stability	Number of participants whose access to stable permanent housing improves after the intervention.	Baseline to up to 9 months
Change in Savings	Number of participants whose savings increase after the intervention.	Baseline to up to 9 months
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
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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Eric Benotsch, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): November 17, 2022

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HM20011245; R34MH115775 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No