Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Prevention

Treatments: Behavioral: PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2); Behavioral: PrEP N' Shine: Strength Based Case Management (Stage 1)

Study type: Interventional

Funder types: Other

Identifiers

NCT05016232

1R34MH122499-01A1

Details and patient eligibility

About

"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).

Full 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.

Enrollment: 123 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 2 patient groups

Strength Based Case Management (SBCM) & PrEP adherence training and counseling

Experimental group

Description:

Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. Stage 2: Stepped Intervention: 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.

Treatment:

Behavioral: PrEP N' Shine: Strength Based Case Management (Stage 1)

Behavioral: PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)

Standard of Care:Stage 1 and Stage 2

No Intervention group

Description:

Stage 1: Referral to local PrEP clinic Stage 2: Standard clinical PrEP care: Doctor visit every three months to assess for side effects, do blood work, and receive a HIV test.