Hiv, Transgenderism
Conditions
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.
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.
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.
Sponsors
National Institute of Mental Health (NIMH)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
* obvious signs of intoxication or cognitive impairment * cannot speak English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Employment Status | Baseline to up to 9 months | Number of participants whose status with respect to employment improves after the intervention. |
| Change in Income | Baseline to up to 9 months | Number of participants whose income increases after the intervention. |
| Change in Housing Stability | Baseline to up to 9 months | Number of participants whose access to stable permanent housing improves after the intervention. |
| Change in Savings | Baseline to up to 9 months | Number of participants whose savings increase after the intervention. |
| Change in Self Reported HIV Risk Behavior | 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 | Baseline to up to 9 months | Number of participants who demonstrate higher compliance with recommended biomedical prevention or treatment behaviors after the intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Microeconomic Intervention 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. | 4 |
| Waitlisted Control Overflow | 0 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Non-randomized due to running out of funding | 4 | 0 |
Baseline characteristics
| Characteristic | Microeconomic Intervention | Waitlisted Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 participants | — | 4 participants |
| Sex: Female, Male Female | 4 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 0 |
| other Total, other adverse events | 0 / 4 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4 | 0 / 0 |
Outcome results
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.
Time frame: Baseline to up to 9 months
Population: Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities.
Primary
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
Population: Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities.
Primary
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
Population: Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities.
Primary
Change in Income
Number of participants whose income increases after the intervention.
Time frame: Baseline to up to 9 months
Population: Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities.
Primary
Change in Savings
Number of participants whose savings increase after the intervention.
Time frame: Baseline to up to 9 months
Population: Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities.
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.
Time frame: Baseline to up to 9 months
Population: Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities.