RECRUITING

ASK-PrEP (Assistance Services Knowledge-PrEP)

Description

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.

Conditions

Substance Use DisordersHIV
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Related Conditions:

Substance Use DisordersHIV

Study Overview

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Study Details

Study overview

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.

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

ASK-PrEP (Assistance Services Knowledge-PrEP)

Condition
Substance Use Disorders
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Friends Community Center, Los Angeles, California, United States, 90038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.
  • * 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;

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Friends Research Institute, Inc.,

Cathy J Reback, PhD, PRINCIPAL_INVESTIGATOR, Friends Research Institute, Inc.

Sean M Murphy, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2026-07-30