CClinicalTrials.gg
TerminatedNCT04275310Updated Aug 4, 2023Results posted

Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women

An interventional study of Microeconomic Intervention in Hiv and Transgenderism, sponsored by Virginia Commonwealth University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-04.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Prevention

Why this study was terminated
Loss of funding
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Hiv
  • Transgenderism
03

In context

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • obvious signs of intoxication or cognitive impairment
  • cannot speak English.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Microeconomic intervention

    Behavioral: Microeconomic Intervention

  • No intervention
    Waitlisted control

Interventions

  • BehavioralMicroeconomic 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.

06

What researchers measure

Primary outcomes

  1. Change in Employment Status

    Number of participants whose status with respect to employment improves after the intervention.

    Time frame: Baseline to up to 9 months

  2. Change in Income

    Number of participants whose income increases after the intervention.

    Time frame: Baseline to up to 9 months

  3. Change in Housing Stability

    Number of participants whose access to stable permanent housing improves after the intervention.

    Time frame: Baseline to up to 9 months

  4. Change in Savings

    Number of participants whose savings increase after the intervention.

    Time frame: Baseline to up to 9 months

  5. 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.

    Time frame: Baseline to up to 9 months

  6. 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.

    Time frame: Baseline to up to 9 months

07

Results

Posted Aug 4, 2023
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.

Participant flow

Participant flow — Overall Study
MilestoneMicroeconomic InterventionWaitlisted Control
Started40
Completed00
Not completed40
Withdrew: Non-randomized due to running out of funding40

Outcome measures

PrimaryChange in Employment Status

Number of participants whose status with respect to employment improves after the intervention.

Time frame:
Baseline to up to 9 months

No measurements were reported for this outcome.

PrimaryChange in Income

Number of participants whose income increases after the intervention.

Time frame:
Baseline to up to 9 months

No measurements were reported for this outcome.

PrimaryChange in Housing Stability

Number of participants whose access to stable permanent housing improves after the intervention.

Time frame:
Baseline to up to 9 months

No measurements were reported for this outcome.

PrimaryChange in Savings

Number of participants whose savings increase after the intervention.

Time frame:
Baseline to up to 9 months

No measurements were reported for this outcome.

PrimaryChange 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.

Time frame:
Baseline to up to 9 months

No measurements were reported for this outcome.

PrimaryChange 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.

Time frame:
Baseline to up to 9 months

No measurements were reported for this outcome.

Adverse events

Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Microeconomic Intervention0/4 (0%)0/4 (0%)0/4 (0%)
Waitlisted Control———

Baseline characteristics

No analysis was completed as no study procedures were ever initiated.

Age, Categorical
Age, Categorical(Participants)Microeconomic InterventionWaitlisted ControlTotal
<=18 years000
Between 18 and 65 years404
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Microeconomic InterventionWaitlisted ControlTotal
Female404
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Microeconomic InterventionWaitlisted ControlTotal
Hispanic or Latino000
Not Hispanic or Latino404
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Microeconomic InterventionWaitlisted ControlTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American404
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Microeconomic InterventionWaitlisted ControlTotal
United States4—4
08

Study locations

1 site
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 23, 2020
  • Informed consent form · Mar 23, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04275310
Lead sponsor
Virginia Commonwealth University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Feb 19, 2020
Start date
Jul 20, 2022
Primary completion
Nov 17, 2022
Completion
Nov 17, 2022
Results posted
Aug 4, 2023
Last update
Aug 4, 2023

Study contacts

Eric Benotsch, PhD
principal investigator · Virginia Commonwealth University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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