Increasing PrEP With Trans Women in the Deep South

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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T'Cher, Take Charge: Increasing PrEP Awareness, Uptake and Adherence Through Health Care Empowerment and Addressing Social Determinants of Health Among Racially Diverse Trans Women in the Deep South

Conditions
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Hiv

Intervention / Treatment
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* Behavioral: Peer PrEP Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Declaration of willingness to comply with all study procedures and availability during the study Age 18 years old or older Male sex designated at birth Identify as trans woman, woman or another gender identity not associated with being a man Desire to use or re-start PrEP HIV uninfected Speaks English or Spanish Live in the New Orleans metropolitan statistical area (which includes 8 parishes) Exclusion Criteria: Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above) Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity Concurrent or planned enrollment in a research study that provides PrEP Unwilling to attend quarterly follow-up visits, which will include survey participation 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be recruited on a rolling basis for a randomized, unblinded, cross-over stepped wedge study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEP peer navigation<br>Culturally informed health care empowerment and PrEP peer navigation and support through social determinant of health stressors | Behavioral: Peer PrEP Navigation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP uptake | The proportion of participants enrolled in the study who begin to take PrEP | 24 months | 
| Social determinant stressors | The proportion of participants enrolled in the study who address social determinant stressors | 24 months | 
| Health care empowerment | The proportion of participants enrolled in the study who report improved healthcare empowerment | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns and correlates of PrEP adherence | 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 | 24 months |