Increasing PrEP With Trans Women in the Deep South (T'Cher)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hiv
• Intervention / Treatment: Behavioral: Peer PrEP Navigation

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Narquis Barak, MS; Phone Number: 1058 504.821.2601; Email: narquis.barak@crescentcare.org
• Study Contact Backup: Name: Erin Meek, DrPH; Phone Number: 628-217-6113; Email: erin.wilson@sfdph.org

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70117
      • Recruiting
      • NO/AIDS Task Force d.b.a. CrescentCare
      • Contact: Narquis Barak, MA; Phone Number: 504-821-2601; Email: narquis.barak@crescentcare.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CrescentCare

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Anticipated): July 31, 2026
• Study Completion (Anticipated): July 31, 2026

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 10275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No