Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women
- Conditions
- Prevention
- Registration Number
- NCT05016232
- Lead Sponsor
- University of California, Los Angeles
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 123
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Concentrations of TFV-DP in Dried Blood Spots at 6 months Stage 2: 6 months post-baseline Dried Blood Spots (DBS) to be sent to the laboratory to test for tenofovir-diphosphate (700+ fmol/punch - corresponding to levels that are consistent with taking 4+ pills per week), which will serve as a biological measure of PrEP adherence
Verified medical visit and PrEP prescription Stage 1: one month post-baseline Linkage to care and PrEP Initiation measured through verified medical appointment at PrEP Clinic and pharmacy through medical release.
Concentrations of TFV-DP in Dried Blood Spots at 3 months Stage 2: 3 months post-baseline Dried Blood Spots (DBS) to be sent to the laboratory to test for tenofovir-diphosphate (700+ fmol/punch - corresponding to levels that are consistent with taking 4+ pills per week), which will serve as a biological measure of PrEP adherence.
- Secondary Outcome Measures
Name Time Method Change in sexual risk behavior based on self report Stage 2: Change from baseline sexual risk behavior at 6 months Change in sexual risk behavior to be measured using AIDS-Risk Behavior Assessment (ARBA), a computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to three types of sexual behavior (anal, oral, vaginal) and assess detailed sexual risk information by partner type (transactional, casual, main) and by HIV-status, whether protected or unprotected, and whether in the context of substance use in past 3 months.
Trial Locations
- Locations (1)
UCLA Center for LGBTQ+ Advocacy, Research & Health
🇺🇸Los Angeles, California, United States