Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around

Description

Summary

ASK-PrEP is a two-arm randomized controlled trial (RCT), with a Stepped Care approach, among HIV-negative trans women and men who have sex with men with a substance use disorder (SUD). Participants will be randomized (3:1) to the ASK-PrEP Stepped Care arm or Standard of Care (SOC). Participants in the ASK-PrEP Stepped Care arm will receive 5 PrEP navigation sessions, with weekly text-messaging support, delivered over 3 months, at which point they will be assessed for intervention response. Responders will be maintained for an additional 3 months in ASK-PrEP to receive an additional 5 PrEP navigation session with weekly text-messaging support, while non-responders will receive added attention to their SUD via contingency management (CM). Non-responders will be re-randomized (1:1) to either a) receive ASK-PrEP + CM, or b) shift the primary focus to their SUD (CM alone) for an additional 3 months.

Official Title

Optimizing PrEP Implementation and Cost-effectiveness Among Sexual and Gender Minority Individuals With a Substance Use Disorder

Details

Keywords

Substance Use Disorders, HIV, PrEP, MSM, transgender women, substance use disorder, Substance-Related Disorders, PrEP navigation + text messaging, Contingency Management, ASK-PrEP

Eligibility

Location

  • Friends Community Center accepting new patients
    Los Angeles California 90038 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Friends Research Institute, Inc.
ID
NCT05934877
Study Type
Interventional
Participants
Expecting 250 study participants
Last Updated