RECRUITING

Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services

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

The proposed study will be a 24-week intervention with a 12-month follow-up period to evaluate the impact of contingency management with stepped care to pre-exposure prophylaxis (PrEP) adherence and support services (CoMPASS) to promote HIV prevention among individuals with opioid use disorder who have injected drugs in their lifetime. In parallel, the investigators will conduct an implementation focused process evaluation to inform real-world implementation of CoMPASS. .

Official Title

Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services

Quick Facts

Study Start:2021-10-04
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04738825

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:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Receive or willing to receive care at one of the participating study sites
  2. 2. Have a recent negative HIV test with no concern for acute HIV
  3. 3. Report injection drug use in their lifetime
  4. 4. Meet PrEP eligibility criteria by either a) sharing of injection or drug preparation equipment; b) sexual risk behaviors (i.e. condomless sex or STI) in the past 6 months
  5. 5. Meet Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM5) criteria for opioid use disorder
  6. 6. Have a phone or use of a household member's phone
  7. 7. Provide written informed consent
  8. 1. Currently employed at one of the participating study sites
  9. 2. Willing to complete a web-based survey
  1. 1. Currently prescribed PrEP
  2. 2. Self-report or urine test confirming pregnancy, breastfeeding, or trying to conceive
  3. 3. Any plans that would preclude study completion (surgery, major medical treatment or conditions, incarceration, travel out of state or country.)
  4. 4. Inability to provide at least one collateral contact for a friend or family member.
  5. 5. Non-English speaking (for sites without Spanish-speaking staff)
  6. 6. Have kidney disease (a contraindication to PrEP)
  7. 1. Non-English speaking

Contacts and Locations

Study Contact

June-Marie C Weiss, MA, MEd
CONTACT
203-737-3347
junemarie.weiss@yale.edu

Principal Investigator

E. Jennifer Edelman, MD, MHS
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Recovery Network of Programs, Inc
Bridgeport, Connecticut, 06484
United States
Liberations Program, Inc
Bridgeport, Connecticut, 06604
United States
Apex Community Care. Inc.
Danbury, Connecticut, 06810
United States
Greater Hartford Harm Reduction Coalition- SWAN
New Haven, Connecticut, 06511
United States
APT
New Haven, Connecticut, 06519
United States
Stanley Street Treatment and Resource Center
Fall River, Massachusetts, 02720
United States

Collaborators and Investigators

Sponsor: Yale University

  • E. Jennifer Edelman, MD, MHS, PRINCIPAL_INVESTIGATOR, Yale 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 Date2021-10-04
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-10-04
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • People who inject drugs
  • Pre-exposure prophylaxis (PrEP)
  • Medications for opioid use disorder
  • Opioid use disorder
  • HIV prevention

Additional Relevant MeSH Terms

  • Opioid-use Disorder
  • HIV Prevention Program