NCT06843213

Brief Summary

The purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of health resilience and promotion 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 health resilience 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Feb 2025Aug 2028

First Submitted

Initial submission to the registry

January 13, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

January 13, 2025

Last Update Submit

February 24, 2026

Conditions

Keywords

Opioid Use DisorderHarm ReductionPeer SupportPeer Support Specialists

Outcome Measures

Primary Outcomes (1)

  • 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

    Cumulative incidence of non-fatal overdose OR skin and soft tissue infection

    Baseline to 6 months

Secondary Outcomes (2)

  • Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of non-fatal overdoses

    Baseline to 6 months

  • Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of skin and soft tissue infections

    Baseline to 6 months

Other Outcomes (8)

  • Effectiveness of the THRIVE intervention on change in higher risk infection behaviors (characterized by BIRSI score) compared to EUC

    Baseline to 6 months

  • Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (a)

    Baseline to 6 months

  • Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (b)

    Baseline to 6 months

  • +5 more other outcomes

Study Arms (2)

Peer Intervention

EXPERIMENTAL
Behavioral: Peer Intervention

Enhanced Usual Care

OTHER
Other: Enhanced Usual Care

Interventions

Participants will receive one peer-led, in-person session boosted by weekly text messages over a 12-week period.

Peer Intervention

Participants will receive a handout that includes health resilience education and resources in their local area as part of enhanced usual care.

Enhanced Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15203, United States

NOT YET RECRUITING

UPMC Presbyterian-Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

NOT YET RECRUITING

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MeSH Terms

Conditions

Opioid-Related DisordersHarm Reduction

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Jacqueline D Wilson, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Program Coordinator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

February 24, 2025

Study Start

February 18, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations