ASK-PrEP (Assistance Services Knowledge-PrEP)

Stopped early · Not applicable

Conditions studied: Substance Use Disorders, HIV

In brief

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.

Key facts

Study ID

NCT05934877

Run by

Friends Research Institute, Inc.

People needed

152

Starts

2023-05-11

Expected to finish

2025-03-19

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• self-identified transgender woman or MSM
• ≥18 years old
• verified HIV negative
• identified as high risk for HIV based on the Los Angeles County criteria
• SUD (injection and non-injection; excluding cannabis (CUD) only
• For those who have already initiated PrEP there is an additional eligibility criterion:
• non-protective prophylaxis defined as missed ≥4 doses of PrEP/week during any week in the previous 30 days
• no PrEP care visits in the past 3 months
• willing to provide informed consent; and
• willing to comply with study requirements.
• Should a participant be identified as having kidney or liver dysfunction sufficient to contraindicate PrEP use (creatinine clearance <60 mL/min), that individual will be withdrawn from study participation but may re-screen for eligibility once adequate renal and/or liver function has been established and medically documented (≥60 mL/min).

You may not qualify if…

• does not identify as a trans woman or male who has sex with men
• under 18 years of age
• HIV positive status
• not identified as high risk for HIV based on the Los Angeles County criteria
• no verified SUD or only CUD
• if already initiated PrEP: PrEP adherent and PrEP care visits in the past 3 months
• unwilling to provide informed consent
• unwilling to comply with study requirements;

Where it is running

• Friends Community Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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