"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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
123
Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
1. Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and 2. Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist.
UCLA Center for LGBTQ+ Advocacy, Research & Health
Los Angeles, California, United States
Verified medical visit and PrEP prescription
Linkage to care and PrEP Initiation measured through verified medical appointment at PrEP Clinic and pharmacy through medical release.
Time frame: Stage 1: one month post-baseline
Concentrations of TFV-DP in Dried Blood Spots at 3 months
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.
Time frame: Stage 2: 3 months post-baseline
Concentrations of TFV-DP in Dried Blood Spots at 6 months
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
Time frame: Stage 2: 6 months post-baseline
Change in sexual risk behavior based on self report
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.
Time frame: Stage 2: Change from baseline sexual risk behavior at 6 months
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