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ASK-PrEP (Assistance Services Knowledge-PrEP)

TerminatedNA

Sponsor: Friends Research Institute, Inc.

Conditions: Substance Use Disorders, HIV

Interventions: PrEP navigation + text messaging, Standard of Care, Contingency Management

Countries: United States

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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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60 mL/min), that individual will be withdrawn from study participation but may re-screen for eligibility once adequate renal and/or liver function has been established and medically documented (≥60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).

Exclusion Criteria:

* 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;

Locations (1)

Los Angeles, California, United States