RECRUITING

ASK-PrEP (Assistance Services Knowledge-PrEP)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-05-11
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05934877

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * self-identified transgender woman or MSM
  2. * ≥18 years old
  3. * verified HIV negative
  4. * identified as high risk for HIV based on the Los Angeles County criteria
  5. * SUD (injection and non-injection; excluding cannabis (CUD) only
  6. * non-protective prophylaxis defined as missed ≥4 doses of PrEP/week during any week in the previous 30 days
  7. * no PrEP care visits in the past 3 months
  8. * willing to provide informed consent; and
  9. * willing to comply with study requirements.
  1. * does not identify as a trans woman or male who has sex with men
  2. * under 18 years of age
  3. * HIV positive status
  4. * not identified as high risk for HIV based on the Los Angeles County criteria
  5. * no verified SUD or only CUD
  6. * if already initiated PrEP: PrEP adherent and PrEP care visits in the past 3 months
  7. * unwilling to provide informed consent
  8. * unwilling to comply with study requirements;

Contacts and Locations

Study Contact

Cathy J Reback, PhD
CONTACT
323-463-1601
reback@friendsresearch.org
Sean M Murphy, PhD
CONTACT
646-962-9710
smm2010@med.cornell.edu

Principal Investigator

Cathy J Reback, PhD
PRINCIPAL_INVESTIGATOR
Friends Research Institute, Inc.
Sean M Murphy, PhD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Friends Community Center
Los Angeles, California, 90038
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-11
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2023-05-11
Study Completion Date2026-07-30

Terms related to this study

Keywords Provided by Researchers

  • PrEP
  • HIV
  • MSM
  • transgender women
  • substance use disorder

Additional Relevant MeSH Terms

  • Substance Use Disorders
  • HIV