Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women

NCT04275310 | Terminated Results

• 2 other identifiers: HM20011245R34MH115775
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hiv; Transgenderism

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Microeconomic intervention

EXPERIMENTAL

Behavioral: Microeconomic Intervention

Waitlisted control

NO INTERVENTION

Interventions

Microeconomic Intervention BEHAVIORAL

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.

Microeconomic intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Transgender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Transgender woman
• 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).

You may not qualify if:

• obvious signs of intoxication or cognitive impairment
• cannot speak English.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Transsexualism

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexuality; Sexual Behavior; Behavior

Limitations and Caveats

Early termination due to loss of funding. As a result a small number of participants were consented. None of those consented did any study-related activities and therefore no data was collected to analyze.

Results Point of Contact

• Title: Eric Benotsch
• Organization: Virginia Commonwealth University

ebenotsch@vcu.edu

804-828-0133

Study Officials

• Eric Benotsch, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 19, 2020
• Study Start: July 20, 2022
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: August 4, 2023
• Results First Posted: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)