Summary

Eligibility
for males ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Matthew Mimiaga (ucla)

Description

Summary

"PrEP N' Shine" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Transgender women (TGW).

Official Title

Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence Among At-Risk Transgender Women

Details

The "PrEP N' Shine" package includes two behavioral intervention components: 1. Peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake, and 2. A resource-efficient, adaptive "stepped-care" technology and counseling intervention that addresses individualized barriers to optimal use. Stage 1: TGW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic. Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEP N' Shine" adherence intervention or standard of care comparison condition.

Keywords

Prevention, Transgender women (TGW), HIV Prevention, PrEP, PrEP N' Shine: Strength Based Case Management (Stage 1), PrEP adherence training and counseling

Eligibility

You can join if…

Open to males ages 18 years and up

  • Age: 18 years or older
  • Male sex at birth
  • Self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum
  • PrEP naïve
  • PrEP indicated per CDC guidelines (incl. HIV negative)
  • Owns a cell phone or willing to use one in the study
  • Able to understand and speak English or Spanish

You CAN'T join if...

  • Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at time of visit
  • Has lived in RI for less than three months (as a means to enhance participant retention)
  • Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
  • Laboratory or clinical findings that would preclude PrEP initiation (e.g. Hepatitis B infection, decreased creatinine clearance)

Location

  • UCLA Center for LGBTQ+ Advocacy, Research & Health accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05016232
Study Type
Interventional
Participants
Expecting 106 study participants
Last Updated