NCT05016232

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prevention

Interventions

Type	Name	Description
BEHAVIORAL	PrEP N' Shine: Strength Based Case Management (Stage 1)	Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
BEHAVIORAL	PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)	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.

Timeline

• Start date: 2022-10-18
• Primary completion: 2024-05-31
• Completion: 2024-06-30
• First posted: 2021-08-23
• Last updated: 2024-07-25

Locations

1 site across 1 country: United States