Peer Support for Liver Transplant Recipients With History of ALD (THRIVES)

Peer Support to Enhance Care for Liver Transplant Recipients Who Had Alcohol-Associated Liver Disease

Liver transplant (LT) recipients with a history of alcohol-related liver disease (ALD) may encounter various psychosocial and medical challenges during post-LT recovery, even beyond the initial post-transplant period. Effective and sustainable interventions will be crucial for improving patient outcomes. This clinical trial will examine the impact of peer support specialists (PSS) on the recovery experience of individuals who received LT for ALD. The trial seeks to answer two main questions:

• Are LT recipients who work with PSS less likely to resume alcohol use or tend to drink less overall?
• Do LT recipients who work with PSS engage more with recommended medical care and have better overall survival?

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Use Disorder; Liver Transplant Recipient; Alcohol Related Liver Disease
• Intervention / Treatment: Behavioral: Peer Support

Detailed Description

In the United States, ALD is the most common indication for LT. Resuming alcohol use is a major concern for all LT recipients with a history of ALD, with estimates ranging from 16% to 49% and increasing with more time since LT. Although most LT programs have required pre-LT alcohol treatment, post-LT services have been far more heterogeneous, despite the potentially severe consequences of alcohol relapse during this period. The present study proposes implementing and evaluating a care model for LT recipients with a history of ALD after the first post-LT year. The investigators will conduct a single-arm clinical trial to integrate PSS into routine medical care starting in years 2 through 4 following LT. The study will recruit PSS based on lived experiences with ALD/LT and interpersonal skills. The PSS will first receive tailored skills training from the study team in areas such as delivering brief counseling, active listening, and maintaining confidentiality. The PSS will then meet with study participants at regular intervals between standard clinic visits. The investigators will follow participants working with PSS for 1 year and compare the participants with a historical control group of transplant recipients without PSS to determine whether the intervention improves outcomes. Key endpoints will include alcohol use (by self-report and biomarker), retention in post-transplant medical care, and overall survival.

• Study Type: Interventional
• Enrollment (Estimated): 95
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Po-Hung Chen, MD, PhD; Phone Number: 410-550-1793; Email: pchen37@jhmi.edu
• Study Contact Backup: Name: Mary E. McCaul, PhD; Phone Number: 410-955-9526; Email: mmccaul1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine
      • Contact: Po-Hung Chen, MD, PhD; Phone Number: 410-550-1793; Email: pchen37@jhmi.edu
      • Contact: Mary E. McCaul, PhD; Phone Number: 410-955-9526; Email: mmccaul1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English speakers
• Received a liver transplant for alcohol-associated liver disease
• Has 1 to 3 years of continuous alcohol abstinence at the time of trial entry

Exclusion Criteria:

• Liver transplant recipients without a history of alcohol-associated liver disease
• Inability to provide informed consent
• Active participation in a separate intervention trial for alcohol use disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Peer Support Specialist (PSS)

Behavioral: Peer Support; The study will recruit PSS based on lived experiences with ALD/LT and interpersonal skills. The PSS will receive tailored skills training from the study team in areas such as delivering brief counseling, active listening, and maintaining confidentiality. Participants will meet regularly with a PSS between standard clinic visits throughout a one-year study period. The PSS will deliver brief counseling interventions at each session. Study investigators will meet with the PSS at scheduled intervals to review progress. Study investigators will also review up to 20% of the audio recordings of sessions between PSS and study participants to assess fidelity to the intervention protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Consumption	Any use or excessive use (i.e., >7/>14 drinks per week for women/men) by biomarker or self-report	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Transplant Medical Treatment Engagement	Proportion of kept/scheduled LT follow-up medical appointments	Up to 1 year
Overall Post-Liver Transplant Survival	All-cause mortality	Up to 1 year

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Po-Hung Chen, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Alcohol use disorder; Liver transplant recipient; Alcohol Related Liver Disease; Peer support specialist
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: IRB00466249; P50AA027054 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient reported outcomes and phosphatidylethanol biomarker results
• IPD Sharing Time Frame: Data will be shared with the general research community at the time of an associated publication, or the end of the award/grant period, whichever comes first. Data will be shared indefinitely.
• IPD Sharing Access Criteria: Summaries of NIAAA Data Archive (NIAAADA) data are publicly available to anyone through the NDA Query Tool without an account. Access to individual participant data and supporting documentation is limited to qualified researchers who create an NDA account and submit a Data Access Request (DAR), including completion of the NDA Data Use Certification (DUC). Requests are reviewed by a NIAAA committee to ensure responsible data use. Individual-level data are accessed through the NDA Query Tool once approval is granted.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No