Peer Engagement in Methamphetamine Harm-Reduction With Contingency Management (PEER-CM)

Sponsor
Oregon Health and Science University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05700994
Collaborator
Comagine Health (Other), Oregon Health Authority (Other)
1,800
2
42

Study Details

Study Description

Brief Summary

The main goal of this study is to tests the effect of incentivizing achievement of self-identified, personal harm reduction goals (Contingency management or CM) compared with standard of care (peer harm reduction service with incentives for peer visits) to increase the reach and effectiveness of methamphetamine (MA) harm reduction services.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer Contingency Management
  • Behavioral: Standard of Care Contingency Management
N/A

Detailed Description

Using a hybrid type 1 effectiveness-implementation framework and stepped-wedge design, this study will randomize eighteen community-based peer harm reduction sites to provide contingency management incentives for achieving self-identified harm reduction goals set with peer specialists using a participant-driven harm reduction goal-setting process (e.g. completing overdose prevention and supply training, daily life goals, treatment and care goals, relationship and social support goals) versus standard of care contingency management (i.e. incentives for peer encounter attendance).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
This is a cluster-randomized pragmatic trial using a hybrid type 1 effectiveness-implementation framework and stepped-wedge design.This is a cluster-randomized pragmatic trial using a hybrid type 1 effectiveness-implementation framework and stepped-wedge design.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Peer Engagement in Methamphetamine Harm-Reduction With Contingency Management (PEER-CM)
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: PEER-CM

Peer-facilitated contingency management (PEER-CM).

Behavioral: Peer Contingency Management
Participants allocated to peer-facilitated contingency management will receive incentives for achieving self-identified harm reduction goals set with peer specialists using a participant-driven harm reduction goal-setting process (e.g. completing overdose prevention and supply training, daily life goals, treatment and care goals, relationship and social support goals)
Other Names:
  • PEER-CM
  • Active Comparator: Standard of Care

    Standard of care contingency management.

    Behavioral: Standard of Care Contingency Management
    Participants allocated to standard of care contingency management will receive incentives for peer encounters.
    Other Names:
  • Standard of Care
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants who overdose [6 months from baseline]

      Test the impact of incentives for achieving self-identified, personal harm reduction goals on the likelihood of overdose among people using methamphetamine at 6 months from enrollment identified through completed assessment.

    2. Number of participants who achieve self-identified goals [6 months from baseline]

      Determine whether incentives for achieving self-identified, personal harm reduction goals increases engagement with harm reduction services at 6 months from enrollment identified through completed assessment.

    3. Number of participants who engage in substance use disorder treatment [6 months from baseline]

      Determine whether incentives for achieving self-identified, personal harm reduction goals increases engagement with treatment services at 6 months from enrollment identified through completed assessment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 105 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    This intervention is at the site level. Community-based organization sites are eligible if they use peer support specialists to provide direct outreach and harm reduction services to people who use drugs and if they are willing to be trained in the two strategies for peer-facilitated contingency management.

    De-identified administrative data is used to identify an analytic sample of clients who reported past 30-day methamphetamine use at community-based organization intake. Client outcomes are assessed using de-identified administrative data.

    Exclusion Criteria:

    Community-based organization sites who do not use peer support specialists to provide direct outreach and harm reduction services to people who use drugs or are not willing to be trained in the two strategies for peer-facilitated contingency management.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Oregon Health and Science University
    • Comagine Health
    • Oregon Health Authority

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    P. Todd Korthuis, MD, Professor, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT05700994
    Other Study ID Numbers:
    • PEER-CM
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 26, 2023