Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-31 @ 4:11 AM
Study NCT ID:
NCT05016232
Status:
COMPLETED
Last Update Posted:
2024-07-25
First Post:
2021-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women
Sponsor:
University of California, Los Angeles
Organization:
Study Overview
Official Title:
Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence Among At-Risk Transgender Women
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: