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TerminatedNo phase

ASK-PrEP (Assistance Services Knowledge-PrEP)

Key facts

Who runs it
Friends Research Institute, Inc.
Where
Los Angeles, United StatesSee the site
Trial code
Status
Terminated
People taking part
152 people enrolled
Started
11 May 2023
Ended
19 Mar 2025
Type of study
Interventional, 2 groups
Treatments tested
  • PrEP navigation + text messaging
  • Standard of Care
  • Contingency Management
Record updated
11 February 2026
Why it stopped
President Trump's Executive Order

Who can take part

Age
18 years and older
Sex
Men only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

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60 mL/min), that individual will be withdrawn from study participation but may re-screen for eligibility once adequate renal and/or liver function has been established and medically documented (≥60 mL/min)

Who cannot take part

  • HIV positive status
  • not identified as high risk for HIV based on the Los Angeles County criteria
  • under 18 years of age
  • does not identify as a trans woman or male who has sex with men
  • 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 in United States

  • Friends Community CenterLos Angeles, United States

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • ASK-PrEPTreatment being tested

    ASK-PrEP is a 5-session PrEP navigation intervention, with text-messaging support, to advance through the PrEP Care Continuum by identifying the individual needs and barriers to PrEP care, including substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Intervention/treatment: PrEP navigation + text messaging Participants receive 5 PrEP navigation sessions within 3 months plus a weekly culturally specific, scripted text message. Participants that do not respond to the ASK-PrEP intervention at the 3-month assessment are re-randomized (1:1) and stepped up to receive ASK-PrEP plus CM or CM alone.

    Treatment: PrEP navigation + text messaging and Contingency Management

  • Education and InformationTreatment being tested

    The Standard of Care (SOC) intervention includes a 20-30-minute session of PrEP information and where to access PrEP in Los Angeles. The same session is repeated at the 3-month assessment. Participants randomized to the SOC arm receive 2 educational/informational sessions on PrEP misconceptions, uptake, and adherence. The sessions occur at baseline and the 3-month assessment.

    Treatment: Standard of Care

Results explained

A paper that names this trial, explained in plain words.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Optimizing PrEP Implementation and Cost-effectiveness Among Sexual and Gender Minority Individuals With a Substance Use Disorder
Publications
Record updated
11 February 2026