Clinical trial NCT05016232: Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women
Official title: Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence Among At-Risk Transgender Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention
Keywords: Transgender women (TGW)
HIV Prevention
PrEP
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2021-08-23
Enrollment: 123
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Verified medical visit and PrEP prescription
timeFrame: Stage 1: one month post-baseline
measure: Concentrations of TFV-DP in Dried Blood Spots at 3 months
timeFrame: Stage 2: 3 months post-baseline
measure: Concentrations of TFV-DP in Dried Blood Spots at 6 months
timeFrame: Stage 2: 6 months post-baseline
Secondary outcomes:
measure: Change in sexual risk behavior based on self report
timeFrame: Stage 2: Change from baseline sexual risk behavior at 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for LGBTQ+ Advocacy, Research & Health
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Matthew Mimiaga, ScD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
References: