Increasing PrEP With Trans Women in the Deep South

Hiv Clinical Trial

— T'Cher  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689281
• Other study ID #: 10275
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: March 2023
• Source: CrescentCare
• Contact: Narquis Barak, MS
• Phone: 504.821.2601
• Email: narquis.barak[@]crescentcare.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

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.

Locations

Country	Name	City	State
United States	NO/AIDS Task Force d.b.a. CrescentCare	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
CrescentCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP uptake	The proportion of participants enrolled in the study who begin to take PrEP	24 months
Primary	Social determinant stressors	The proportion of participants enrolled in the study who address social determinant stressors	24 months
Primary	Health care empowerment	The proportion of participants enrolled in the study who report improved healthcare empowerment	24 months
Secondary	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