T'Cher: Increasing PrEP With Trans Women in the Deep South
Study Details
Study Description
Brief Summary
The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
The intervention will also assess changes in health care empowerment and support for Social Determinants of Health (SDoH) as mediating the effect of the intervention on PrEP uptake and adherence among trans women.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: PrEP peer navigation Culturally informed health care empowerment and PrEP peer navigation and support through social determinant of health stressors |
Behavioral: Peer PrEP Navigation
Ecological momentary assessments to identify and address stressors related to social determinants of health (e.g., housing, substance use, mental health), and motivational interviewing to support participants' health care empowerment and progression along the PrEP continuum.
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Outcome Measures
Primary Outcome Measures
- PrEP uptake [24 months]
The proportion of participants enrolled in the study who begin to take PrEP
- Social determinant stressors [24 months]
The proportion of participants enrolled in the study who address social determinant stressors
- Health care empowerment [24 months]
The proportion of participants enrolled in the study who report improved healthcare empowerment
Secondary Outcome Measures
- Patterns and correlates of PrEP adherence [24 months]
Analysis of PrEP adherence among those who begin PrEP. Patterns and correlates of adherence will be measures using data from self report surveys and urine assays
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of signed and dated informed consent form
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Declaration of willingness to comply with all study procedures and availability during the study
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Age 18 years old or older
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Male sex designated at birth
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Identify as trans woman, woman or another gender identity not associated with being a man
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Desire to use or re-start PrEP
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HIV uninfected
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Speaks English or Spanish
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Live in the New Orleans metropolitan statistical area (which includes 8 parishes)
Exclusion Criteria:
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Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above)
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Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity
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Concurrent or planned enrollment in a research study that provides PrEP
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Unwilling to attend quarterly follow-up visits, which will include survey participation
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Has any other condition which, based on the opinion of the investigator, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | NO/AIDS Task Force d.b.a. CrescentCare | New Orleans | Louisiana | United States | 70117 |
Sponsors and Collaborators
- CrescentCare
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10275