Teaching Harm Reduction in a Hospital Setting: A Peer-led Intervention
NCT ID: NCT06843213
Last Updated: 2025-09-17
Study Results
Results pending
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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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
390 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-02-18
Study Completion Date
2028-08-01
Brief Summary
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The purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of harm reduction services to be delivered in the hospital setting, called the THRIVE intervention.
The main question it aims to answer is: Will participants receiving the THRIVE intervention have a reduced risk of self-reported non-fatal overdoses OR skin/soft tissue infections compared to participants receiving enhanced usual care?
Researchers will compare the THRIVE model to enhanced usual care to see if the THRIVE model helps participants reduce their number of self-reported non-fatal overdoses OR skin/soft tissue infections.
Intervention participants will:
* Receive one in-person session from a peer support specialist while in the hospital
* Receive weekly text messages from the peer support specialist for a 12-week period
* Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
* Complete a baseline, 3-month, and 6-month assessment with Research Assistants
Enhanced usual care participants will:
* Receive a handout with harm reduction education and resources in their local area
* Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
* Complete a baseline, 3-month, and 6-month assessment with Research Assistants
The main question it aims to answer is: Will participants receiving the THRIVE intervention have a reduced risk of self-reported non-fatal overdoses OR skin/soft tissue infections compared to participants receiving enhanced usual care?
Researchers will compare the THRIVE model to enhanced usual care to see if the THRIVE model helps participants reduce their number of self-reported non-fatal overdoses OR skin/soft tissue infections.
Intervention participants will:
* Receive one in-person session from a peer support specialist while in the hospital
* Receive weekly text messages from the peer support specialist for a 12-week period
* Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
* Complete a baseline, 3-month, and 6-month assessment with Research Assistants
Enhanced usual care participants will:
* Receive a handout with harm reduction education and resources in their local area
* Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
* Complete a baseline, 3-month, and 6-month assessment with Research Assistants
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Detailed Description
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Conditions
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Opioid Use Disorder
Harm Reduction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Peer Intervention
Group Type
EXPERIMENTAL
Peer Intervention
Intervention Type
BEHAVIORAL
Participants will receive one peer-led, in-person session boosted by weekly text messages over a 12-week period.
Enhanced Usual Care
Group Type
OTHER
Enhanced Usual Care
Intervention Type
OTHER
Participants will receive a handout that includes harm reduction education and resources in their local area as part of enhanced usual care.
Interventions
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Peer Intervention
Participants will receive one peer-led, in-person session boosted by weekly text messages over a 12-week period.
Intervention Type
BEHAVIORAL
Enhanced Usual Care
Participants will receive a handout that includes harm reduction education and resources in their local area as part of enhanced usual care.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Participants who are: a) admitted to University of Pittsburgh Medical Center (UPMC) Shadyside Hospital, UPMC Presbyterian-Montefiore Hospital, UPMC Mercy Hospital for inpatient or observation status, or b) seen in the Emergency Department setting at UPMC Presbyterian-Montefiore Hospital and UPMC Mercy Hospital.
* Participants must have a current diagnosis of Opioid Use Disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria.
* Participants must be at least 18 years of age on day of admission.
* Participants must be able to speak and read English.
* Participants must have a current diagnosis of Opioid Use Disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria.
* Participants must be at least 18 years of age on day of admission.
* Participants must be able to speak and read English.
Exclusion Criteria
* Participants diagnosed with dementia and/or cognitive impairments.
* Participants with acute psychiatric complications, such as schizophrenia with acute psychosis, acute mania, or suicidal ideation (which may impact the ability of a participant to consent and actively participate in treatment).
* Participants who are pregnant or lactating at onset of study.
* Participants who cannot read or speak English.
* Participants with acute psychiatric complications, such as schizophrenia with acute psychosis, acute mania, or suicidal ideation (which may impact the ability of a participant to consent and actively participate in treatment).
* Participants who are pregnant or lactating at onset of study.
* Participants who cannot read or speak English.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Sponsor Role
collaborator
University of Pittsburgh
OTHER
Sponsor Role
collaborator
University of Pennsylvania
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jacqueline D Wilson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States
Site Status
NOT_YET_RECRUITING
UPMC Presbyterian-Montefiore Hospital
Pittsburgh, Pennsylvania, United States
Site Status
RECRUITING
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States
Site Status
NOT_YET_RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Harm Reduction Principles. National Harm Reduction Coalition. Accessed September 9, 2022. https://harmreduction.org/about-us/principles-of-harm-reduction/
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Other Identifiers
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857581
Identifier Type: -
Identifier Source: org_study_id
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