Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
NCT ID: NCT04738825
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
526 participants
INTERVENTIONAL
2021-10-04
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Aim 3: Implementation-focused process evaluation to gain information on implementation of the intervention from perspectives of participants as well as front-line providers and staff
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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E. Jennifer Edelman, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Recovery Network of Programs, Inc
Bridgeport, Connecticut, United States
Liberations Program, Inc
Bridgeport, Connecticut, United States
Apex Community Care. Inc.
Danbury, Connecticut, United States
Greater Hartford Harm Reduction Coalition- SWAN
New Haven, Connecticut, United States
APT
New Haven, Connecticut, United States
Stanley Street Treatment and Resource Center
Fall River, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Joanne Montgomery
Role: primary
Mark Jenkins
Role: primary
Lynn Madden
Role: primary
References
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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.
Other Identifiers
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2000029351
Identifier Type: -
Identifier Source: org_study_id
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