Clinical trial NCT06843213: Teaching Harm Reduction in a Hospital Setting: A Peer-led Intervention
Official title: Teaching Harm Reduction in Vulnerable Environments (THRIVE): A Peer-led Intervention Bridging Acute Care Settings and the Discharge to the Community
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Harm Reduction
Keywords: Opioid Use Disorder
Harm Reduction
Peer Support
Peer Support Specialists
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Pittsburgh
First posted: 2025-02-24
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Effectiveness of the THRIVE intervention compared to enhanced usual care (EUC) at lowering the incidence of non-fatal overdoses OR skin and soft tissue infections
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of non-fatal overdoses
timeFrame: Baseline to 6 months
measure: Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of skin and soft tissue infections
timeFrame: Baseline to 6 months
Other outcomes:
measure: Effectiveness of the THRIVE intervention on change in higher risk infection behaviors (characterized by BIRSI score) compared to EUC
timeFrame: Baseline to 6 months
measure: Effectiveness of the THRIVE intervention on change in harm reduction adoption compared to EUC (a)
timeFrame: Baseline to 6 months
measure: Effectiveness of the THRIVE intervention on change in harm reduction adoption compared to EUC (b)
timeFrame: Baseline to 6 months
measure: Effectiveness of the THRIVE intervention on change in harm reduction adoption compared to EUC (c)
timeFrame: Baseline to 6 months
measure: Effectiveness of the THRIVE intervention on harm reduction access compared to EUC (a)
timeFrame: Baseline to 6 months
measure: Effectiveness of the THRIVE intervention on harm reduction access compared to EUC (b)
timeFrame: Baseline to 6 months
measure: Effectiveness of the THRIVE intervention on harm reduction access compared to EUC (c)
timeFrame: Baseline to 6 months
measure: Heterogeneity of treatment effect by race (Black versus white) in the THRIVE intervention arm
timeFrame: Baseline to 6 months
Locations:
city: Pittsburgh
country: United States
facility: UPMC Mercy Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian-Montefiore Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jacqueline D Wilson, MD
role: PRINCIPAL_INVESTIGATOR
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