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

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. .

Study Overview

• Status: Active, not recruiting
• Conditions: Opioid-use Disorder; HIV Prevention Program
• Intervention / Treatment: Behavioral: Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)

Detailed Description

Consistent with a Hybrid Effectiveness-Implementation Type 1 design, this is a multi-site randomized clinical trial designed to evaluate the effectiveness of Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS) vs. treatment as usual (TAU) on HIV risk reduction among individuals with opioid use disorder (OUD) who have injected drugs in their lifetime. The study will be conducted in community-based settings serving individuals with opioid use disorder to assess the effectiveness of CoMPASS on promoting: sustained PrEP adherence (primary outcome) and HIV risk behaviors, engagement in opioid use disorder-related care, opioid use (secondary outcomes); and sexually transmitted infections and HIV (exploratory). Participants randomized to CoMPASS will first receive contingency management and have the potential to earn prizes for making progress towards initiation of and consistent adherence to HIV pre-exposure prophylaxis (PrEP) and engagement in OUD-related care. Individuals who do not demonstrate PrEP adherence (based on self-report, confirmed by urine testing for tenofovir metabolites at week 12), will be "stepped up" to PrEP Adherence and Support Services (PASS). The intervention is 24 weeks in duration. Participants randomized to TAU will receive a health handout on HIV risk reduction approaches, including PrEP and OUD-related care, and where to access such services.

To inform future implementation efforts, factors relevant for scale-up in parallel (e.g., completion of study visits, attitudes regarding the intervention among front-line staff) will be assessed.

• Study Type: Interventional
• Enrollment (Estimated): 526
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06484
      • Recovery Network of Programs, Inc
    • Bridgeport, Connecticut, United States, 06604
      • Liberations Program, Inc
    • Danbury, Connecticut, United States, 06810
      • Apex Community Care. Inc.
    • New Haven, Connecticut, United States, 06511
      • Connecticut Harm Reduction Alliance (GHHRC and SWAN)
    • New Haven, Connecticut, United States, 06519
      • The APT Foundation (Legion and Long Wharf)
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Stanley Street Treatment and Resource Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Aims 1 and 2:

1. Receive or willing to receive care at one of the participating study sites
2. Have a recent negative HIV test with no concern for acute HIV
3. Report injection drug use in their lifetime
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. Meet Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM5) criteria for opioid use disorder
6. Have a phone or use of a household member's phone
7. Provide written informed consent

Aim 3:

1. Currently employed at one of the participating study sites
2. Willing to complete a web-based survey

Exclusion criteria:

Aims 1 and 2:

1. Currently prescribed PrEP
2. Self-report or urine test confirming pregnancy, breastfeeding, or trying to conceive
3. Any plans that would preclude study completion (surgery, major medical treatment or conditions, incarceration, travel out of state or country.)
4. Inability to provide at least one collateral contact for a friend or family member.
5. Non-English speaking (for sites without Spanish-speaking staff)
6. Have kidney disease (a contraindication to PrEP)

Aim 3:

1. Non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual (TAU); Participants randomized to TAU will receive a health handout on HIV risk reduction approaches, including PrEP and OUD-related care, and where to access such services. They will receive standard care as provided by the community-based organization and by their medical provider.
Experimental: Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS); Participants randomized to Compass will also receive a health handout on HIV risk reduction approaches. They will also receive contingency management sessions (n=9). Participants who do not demonstrate PrEP adherence by week 12, will be "stepped up" to receive PrEP adherence and support services (n=5).	Behavioral: Contingency Management with stepped care to PrEP adherence and support services (CoMPASS); Participants will receive contingency management sessions (n=9). Participants who do not demonstrate PrEP adherence by week 12 will be "stepped up" to receive PrEP adherence and support services (n=5).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained PrEP adherence	Determined by tenofovir-diphosphate levels by dried blood spot testing or objective confirmation.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Risk Behaviors	Self-reported HIV risk behaviors	12 weeks
HIV Risk Behaviors	Self-reported HIV risk behaviors	24 weeks
Engagement in opioid use disorder-related care	Self report of engagement in opioid use disorder-related care	12 weeks
Engagement in opioid use disorder-related care	Self report of engagement in opioid use disorder-related care	24 weeks
Extra medical opioid use	Self reported extra medical opioid use	12 weeks
Extra medical opioid use	Self reported extra medical opioid use	24 weeks
Sustained PrEP adherence	Determined by tenofovir-diphosphate levels by dried blood spot testing or objective confirmation.	12 weeks
Recent PrEP adherence	Self-report adherence confirmed by the presence of tenofovir in urine sample or objective confirmation.	12 weeks
Recent PrEP adherence	Self-report adherence confirmed by the presence of tenofovir in urine sample or objective confirmation.	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexually transmitted infection and HIV acquisition	State surveillance data	12 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: E. Jennifer Edelman, MD, MHS, Yale University

Publications and helpful links

General Publications

• Pickering E, Viera A, Sung ML, Davidson D, Bailey G, Buchelli M, Jenkins M, Kolakowski J, Maier L, Edelman EJ, Rash CJ. Readiness to implement contingency management to promote PrEP initiation and adherence among people who inject drugs: results from a multi-site implementation survey. Addict Sci Clin Pract. 2024 Dec 23;19(1):97. doi: 10.1186/s13722-024-00503-4.
• Sung ML, Viera A, Esserman D, Tong G, Davidson D, Aiudi S, Bailey GL, Buchanan AL, Buchelli M, Jenkins M, John B, Kolakowski J, Lame A, Murphy SM, Porter E, Simone L, Paris M, Rash CJ, Edelman EJ. Contingency Management and Pre-Exposure Prophylaxis Adherence Support Services (CoMPASS): A hybrid type 1 effectiveness-implementation study to promote HIV risk reduction among people who inject drugs. Contemp Clin Trials. 2023 Feb;125:107037. doi: 10.1016/j.cct.2022.107037. Epub 2022 Nov 30.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): July 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: HIV prevention; People who inject drugs; Opioid use disorder; Pre-exposure prophylaxis (PrEP); Medications for opioid use disorder
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2000029351; R01DA051871 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No