Increasing PrEP With Trans Women in the Deep South

Not Applicable

Recruiting

• Conditions: Hiv
• Interventions: Behavioral: Peer PrEP Navigation

• Registration Number: NCT05689281
• Lead Sponsor: CrescentCare

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.

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 Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-19
• Study Start: 2023-01-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-06
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PrEP peer navigation	Peer PrEP Navigation	Culturally informed health care empowerment and PrEP peer navigation and support through social determinant of health stressors

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

NO/AIDS Task Force d.b.a. CrescentCare; 🇺🇸 New Orleans, Louisiana, United States