Recruiting

PrEP

Sponsor:

CrescentCare

Code:

NCT05689281

Conditions

Hiv

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Peer PrEP Navigation

Study Details

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.

Conditions

Hiv

Study ID

NCT05689281

Start date

Jan 31, 2023

Status verified date

Mar, 2023

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PrEP peer navigation

Culturally informed health care empowerment and PrEP peer navigation and support through social determinant of health stressors

Interventions

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.

Primary outcome measure

  • PrEP uptake [ Time Frame: 24 months ]
  • Social determinant stressors [ Time Frame: 24 months ]
  • Health care empowerment [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Narquis Barak, MS

504.821.2601narquis.barak@crescentcare.org

Erin Meek, DrPH

628-217-6113erin.wilson@sfdph.org

Locations

NO/AIDS Task Force d.b.a. CrescentCare

Recruiting

New Orleans, Louisiana, United States, 70117

Contacts

Narquis Barak, MA

504-821-2601narquis.barak@crescentcare.org

More Information

Sponsor

CrescentCare

Last update posted

Mar 6, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CrescentCare on 2023-03-06.