ClinicalTrials.gg
RecruitingNCT06843213THRIVEUpdated Sep 21, 2026

Teaching Health Resilience in a Hospital Setting: A Peer-led Intervention

An interventional study of Peer Intervention and Enhanced Usual Care in Opioid Use Disorder, Harm Reduction and Health Promotion, sponsored by University of Pennsylvania. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
262
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Opioid Use Disorder
  • Harm Reduction
  • Health Promotion

Keywords

  • Opioid Use Disorder
  • Harm Reduction
  • Peer Support
  • Peer Support Specialists
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 262 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
262 participants (estimated)

Study arms

  • Experimental
    Peer Intervention

    Behavioral: Peer Intervention

  • Other
    Enhanced Usual Care

    Other: Enhanced Usual Care

Interventions

  • BehavioralPeer Intervention

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

  • OtherEnhanced Usual Care

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

06

What researchers measure

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

    Time frame: Baseline to 6 months

Secondary outcomes

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

    Cumulative incidence of non-fatal overdose

    Time frame: Baseline to 6 months

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

    Cumulative incidence of skin and soft tissue infection

    Time frame: Baseline to 6 months

Other outcomes

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

    Change in higher risk infection behaviors measured as the total score on the BIRSI

    Time frame: Baseline to 6 months

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

    (a) Change in the proportion of participants who self-report naloxone use in past 30 days to reverse another person's overdose

    Time frame: Baseline to 6 months

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

    (b) Change in the proportion of participants who self-report currently carrying naloxone

    Time frame: Baseline to 6 months

  4. Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (c)

    (c) Change in the proportion of participants who self-report using at least one drug checking strategy in the past 30 days

    Time frame: Baseline to 6 months

  5. Effectiveness of the THRIVE intervention on health resilience access compared to EUC (a)

    (a) Change in the proportion of participants who self-report having received at least one of: naloxone, syringes, or new or unused pipes in past 30 days

    Time frame: Baseline to 6 months

  6. Effectiveness of the THRIVE intervention on health resilience access compared to EUC (b)

    (b) Change in the proportion of participants who self-report visiting a syringe services program in past 30 days

    Time frame: Baseline to 6 months

  7. Effectiveness of the THRIVE intervention on health resilience access compared to EUC (c)

    (c) Change in the proportion of participants who self-report receiving any health resilience services from a needle exchange facility in past 30 days

    Time frame: Baseline to 6 months

  8. Heterogeneity of treatment effect by race (Black versus white) in the THRIVE intervention arm

    Cumulative incidence of non-fatal overdose OR skin or soft tissue infection, by race (Black versus white)

    Time frame: Baseline to 6 months

07

Study locations

1 of 3 sites recruiting
  • UPMC Mercy Hospital
    Pittsburgh, Pennsylvania 15203, United States
    Not yet recruiting
    • Research Program Coordinator · Contactthriving@pitt.edu · 412-679-9848
    • Jane M Liebschutz, MD · Principal investigator
  • UPMC Presbyterian-Montefiore Hospital
    Pittsburgh, Pennsylvania 15213, United States
    Recruiting
    • Research Program Coordinator · Contactthriving@pitt.edu · 412-679-9848
    • Jane M Liebschutz, MD · Principal investigator
  • UPMC Shadyside Hospital
    Pittsburgh, Pennsylvania 15232, United States
    Not yet recruiting
    • Research Program Coordinator · Contactthriving@pitt.edu · 412-679-9848
    • Jane M Liebschutz, MD · Principal investigator
08

References and documents

Publications

  • Harm Reduction Principles. National Harm Reduction Coalition. Accessed September 9, 2022. https://harmreduction.org/about-us/principles-of-harm-reduction/
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  • Pauly B, Wallace B, Barber K. Turning a blind eye: implementation of harm reduction in a transitional programme setting. Drugs Educ Prev Policy. 2018;25(1):21-30. doi:10.1080/09687637.2017.1337081
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  • Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21. PubMed 32830383 ↗
  • Phillips KT, Stewart C, Anderson BJ, Liebschutz JM, Herman DS, Stein MD. A randomized controlled trial of a brief behavioral intervention to reduce skin and soft tissue infections among people who inject drugs. Drug Alcohol Depend. 2021 Apr 1;221:108646. doi: 10.1016/j.drugalcdep.2021.108646. Epub 2021 Feb 27. PubMed 33677353 ↗
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  • Kennedy MC, Boyd J, Mayer S, Collins A, Kerr T, McNeil R. Peer worker involvement in low-threshold supervised consumption facilities in the context of an overdose epidemic in Vancouver, Canada. Soc Sci Med. 2019 Mar;225:60-68. doi: 10.1016/j.socscimed.2019.02.014. Epub 2019 Feb 10. PubMed 30798157 ↗
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  • Shrestha S, Stopka TJ, Hughto JMW, Case P, Palacios WR, Reilly B, Green TC. Prevalence and correlates of non-fatal overdose among people who use drugs: findings from rapid assessments in Massachusetts, 2017-2019. Harm Reduct J. 2021 Aug 30;18(1):93. doi: 10.1186/s12954-021-00538-9. PubMed 34461922 ↗
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Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06843213
Responsible party
Sponsor
First posted
Feb 24, 2025
Start date
Feb 18, 2025
Primary completion
Apr 1, 2028 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Sep 21, 2026

Study contacts

Research Program Coordinator
Contact
thriving@pitt.edu
412-679-9848
Jacqueline D Wilson, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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