Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women

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

"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.

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)