HivNCT04275310
Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women
A study testing Microeconomic Intervention in people with Hiv and Transgenderism, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv, Transgenderism
- What is being tested?
- Microeconomic Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to 17 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- obvious signs of intoxication or cognitive impairment
- cannot speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
- Conditions
- Hiv, Transgenderism
- Being tested
- Microeconomic Intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microeconomic InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Microeconomic intervention | Experimental | Not described Receives: Behavioral: Microeconomic Intervention |
| Waitlisted control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Employment Status
Number of participants whose status with respect to employment improves after the intervention.
Measured: Baseline to up to 9 months
Change in Income
Number of participants whose income increases after the intervention.
Measured: Baseline to up to 9 months
Change in Housing Stability
Number of participants whose access to stable permanent housing improves after the intervention.
Measured: Baseline to up to 9 months
Change in Savings
Number of participants whose savings increase after the intervention.
Measured: 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.
Measured: 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.
Measured: Baseline to up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start20 Jul 2022
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Eric Benotsch, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275310
- Sponsor's protocol ID
- HM20011245
- Other IDs
- R34MH115775
- Status last verified
- Aug 2023
- First submitted
- 12 Feb 2020
- Last updated
- 4 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women
- ClinicalTrials.gov ID
- NCT04275310
- Acronym / sponsor ID
- HM20011245
- Conditions
- Hiv, Transgenderism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Posted 4 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microeconomic intervention | Experimental | Behavioral: Microeconomic Intervention |
| Waitlisted control | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Transgender woman
- 18-45 years of age
- 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).
Key exclusion criteria (2 listed)
- obvious signs of intoxication or cognitive impairment
- cannot speak English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microeconomic InterventionThe 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. | Behavioural | Microeconomic intervention |
Primary outcome
Change in Employment Status
Time frame: Baseline to up to 9 months
Number of participants whose status with respect to employment improves after the intervention.
Change in Income
Time frame: Baseline to up to 9 months
Number of participants whose income increases after the intervention.
Change in Housing Stability
Time frame: Baseline to up to 9 months
Number of participants whose access to stable permanent housing improves after the intervention.
Change in Savings
Time frame: Baseline to up to 9 months
Number of participants whose savings increase after the intervention.
Change in Self Reported HIV Risk Behavior
Time frame: Baseline to up to 9 months
Number of participants whose self-reports of behaviors known to increase risk for HIV goes down after the intervention.
Change in Compliance With Recommended Biomedical Prevention or Treatment
Time frame: Baseline to up to 9 months
Number of participants who demonstrate higher compliance with recommended biomedical prevention or treatment behaviors after the intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Benotsch, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microeconomic Intervention in people with Hiv and Transgenderism, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Employment Status (time frame: Baseline to up to 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.