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

Sponsor
CrescentCare (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05689281
Collaborator
(none)
200
1
1
42
4.8

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
  • Behavioral: Peer PrEP Navigation
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

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Participants will be recruited on a rolling basis for a randomized, unblinded, cross-over stepped wedge study designParticipants will be recruited on a rolling basis for a randomized, unblinded, cross-over stepped wedge study design
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Jan 31, 2023
Anticipated Primary Completion Date :
Jul 31, 2026
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. PrEP uptake [24 months]

    The proportion of participants enrolled in the study who begin to take PrEP

  2. Social determinant stressors [24 months]

    The proportion of participants enrolled in the study who address social determinant stressors

  3. Health care empowerment [24 months]

    The proportion of participants enrolled in the study who report improved healthcare empowerment

Secondary Outcome Measures

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Narquis Barak, Principal Investigator, CrescentCare
ClinicalTrials.gov Identifier:
NCT05689281
Other Study ID Numbers:
  • 10275
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 19, 2023