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

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ClinicalTrials.gov Identifier: NCT04738825
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : November 18, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
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 inject drugs. In parallel, the investigators will conduct an implementation focused process evaluation to inform real-world implementation of CoMPASS. .

Condition or disease Intervention/treatment Phase
Opioid-use Disorder HIV Prevention Program Behavioral: Contingency Management with stepped care to PrEP adherence and support services (CoMPASS) Not Applicable

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 inject drugs. 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Aims 1 and 2: Randomized controlled trial to evaluate the effectiveness of contingency management with stepped care to PrEP adherence and support services (Compass) compared to treatment as usual.

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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : May 31, 2025
Estimated Study Completion Date : May 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Sustained PrEP adherence [ Time Frame: 24 weeks ]
    Determined by tenovifir-diphosphate levels by dried blood spot testing.


Secondary Outcome Measures :
  1. Sustained PrEP adherence [ Time Frame: 12 weeks ]
    Determined by tenovifir-diphosphate levels by dried blood spot testing. .

  2. Recent PrEP adherence [ Time Frame: 12 weeks ]
    Self-report adherence confirmed by the presence of tenofivir in urine sample.

  3. HIV Risk Behaviors [ Time Frame: 12 weeks ]
    Self-reported HIV risk behaviors

  4. HIV Risk Behaviors [ Time Frame: 24 weeks ]
    Self-reported HIV risk behaviors

  5. Engagement in opioid use disorder-related care [ Time Frame: 12 weeks ]
    Self report of engagement in opioid use disorder-related care

  6. Engagement in opioid use disorder-related care [ Time Frame: 24 weeks ]
    Self report of engagement in opioid use disorder-related care

  7. Extra medical opioid use [ Time Frame: 12 weeks ]
    Self reported extra medical opioid use

  8. Extra medical opioid use [ Time Frame: 24 weeks ]
    Self reported extra medical opioid use


Other Outcome Measures:
  1. Sexually transmitted infection and HIV acquisition [ Time Frame: 12 months ]
    State surveillance data


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 the past 6 months
  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 cell phone or use of a household member's cell 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 more than 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04738825


Contacts
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Contact: Elizabeth A Porter, MBA 203-737-3347 elizabeth.porter@yale.edu

Locations
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United States, Connecticut
Recovery Network of Programs, Inc Recruiting
Bridgeport, Connecticut, United States, 06484
Principal Investigator: Jennifer Kolakowski, LCSW         
Apex Community Care. Inc. Recruiting
Danbury, Connecticut, United States, 06810
Principal Investigator: Albana Lame, MS         
Greater Hartford Harm Reduction Coalition Recruiting
Hartford, Connecticut, United States, 06112
Principal Investigator: Mark Jenkins         
United States, Massachusetts
Stanley Street Treatment and Resource Center Recruiting
Fall River, Massachusetts, United States, 02720
Principal Investigator: Genie L Bailey, MD         
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: E. Jennifer Edelman, MD, MHS Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04738825    
Other Study ID Numbers: 2000029351
R01DA051871 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
People who inject drugs
Pre-exposure prophylaxis (PrEP)
Medications for opioid use disorder
Opioid use disorder
HIV prevention
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders