NCT05689281

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
3mo left

Started Jan 2023

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2023Jul 2026

First Submitted

Initial submission to the registry

January 6, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

3.5 years

First QC Date

January 6, 2023

Last Update Submit

March 3, 2023

Conditions

Hiv

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Patterns and correlates of PrEP adherence

    24 months

Study Arms (1)

PrEP peer navigation

EXPERIMENTAL

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

Behavioral: Peer PrEP Navigation

Interventions

Peer PrEP NavigationBEHAVIORAL

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.

PrEP peer navigation

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTrans woman
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New Orleans, Louisiana, 70117, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Narquis Barak, MS

CONTACT

504.821.2601narquis.barak@crescentcare.org

Erin Meek, DrPH

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Participants will be recruited on a rolling basis for a randomized, unblinded, cross-over stepped wedge study design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 19, 2023

Study Start

January 31, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)