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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH115775 | U.S. NIH Grant/Contract | View source |
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Loss of funding
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microeconomic intervention | Experimental |
| |
| Waitlisted control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
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:
Transgender women
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| Name | Affiliation | Role |
|---|---|---|
| Eric Benotsch, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Waitlisted Control | Overflow |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No analysis was completed as no study procedures were ever initiated.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Employment Status | Number of participants whose status with respect to employment improves after the intervention. | Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities. | Posted | Baseline to up to 9 months |
|
4 months
For the waitlisted control group, the number of participants at risk for serious adverse events, all-cause mortality and other adverse events is listed as "0." This is because no participants were enrolled into this group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Benotsch | Virginia Commonwealth University | 804-828-0133 | ebenotsch@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2020 | Jun 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2020 | May 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D014189 | Transsexualism |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| BG001 | Waitlisted Control | Overflow |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Waitlisted Control | Overflow |
|
| Primary | Change in Income | Number of participants whose income increases after the intervention. | Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities. | Posted | Baseline to up to 9 months |
|
|
| Primary | Change in Housing Stability | Number of participants whose access to stable permanent housing improves after the intervention. | Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities. | Posted | Baseline to up to 9 months |
|
|
| Primary | Change in Savings | Number of participants whose savings increase after the intervention. | Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities. | Posted | Baseline to up to 9 months |
|
|
| 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. | Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities. | Posted | Baseline to up to 9 months |
|
|
| 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. | Analysis was not completed due to low enrollment, loss of funding and no participants completing study-related activities. | Posted | Baseline to up to 9 months |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Waitlisted Control | Overflow | 0 | 0 | 0 | 0 | 0 | 0 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |