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

• ClinicalTrials.gov Identifier: NCT05700994
• Recruitment Status: Not yet recruiting
• First Posted: January 26, 2023
• Last Update Posted: September 28, 2023
• Sponsor: Oregon Health and Science University
• Collaborators: Comagine Health; Oregon Health Authority
• Information provided by (Responsible Party): P. Todd Korthuis, MD, Oregon Health and Science University

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
Methamphetamine Abuse	Behavioral: Peer Contingency Management; Behavioral: Standard of Care Contingency Management	Not Applicable

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 (Clinical Trial)
• Estimated 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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Peer Engagement in Methamphetamine Harm-Reduction With Contingency Management (PEER-CM)
• Estimated Study Start Date: November 1, 2023
• Estimated Primary Completion Date: June 30, 2025
• Estimated Study Completion Date: September 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 Name: 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 Name: Standard of Care

Outcome Measures

Primary Outcome Measures :

1. Number of participants who overdose [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 105 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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
• 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.

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
• Are not willing to be trained in the two strategies for peer-facilitated contingency management

Contacts and Locations

Contacts

Contact: Todd Korthuis, MD, MPH; 503494-8044; korthuis@ohsu.edu

Contact: Sara McCrimmon, MPH; mccrimmo@ohsu.edu

Sponsors and Collaborators

Oregon Health and Science University

Comagine Health

Oregon Health Authority

More Information

• Responsible Party: P. Todd Korthuis, MD, Professor, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT05700994
• Other Study ID Numbers: PEER-CM
• First Posted: January 26, 2023
• Last Update Posted: September 28, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No