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NCT Number: NCT05689281

Increasing PrEP With 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

New Orleans, Louisiana, 70117, United States

Location status: Recruiting

Location contact

Narquis Barak, MA

CONTACT

[email protected]

504-821-2601

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer PrEP Navigation

Behavioral

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 outcomes

  1. PrEP uptake

    Time frame: 24 months

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

  2. Social determinant stressors

    Time frame: 24 months

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

  3. Health care empowerment

    Time frame: 24 months

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

Secondary outcomes

  1. Patterns and correlates of PrEP adherence

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Meek, DrPH

CONTACT

[email protected]

628-217-6113

Narquis Barak, MS

CONTACT

[email protected]

504.821.2601 ext. 1058

Sponsors and collaborators

Lead sponsor

CrescentCare

Other

Registry information

Official study 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

Acronym: T'Cher

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2023
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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