Peer Support for Liver Transplant Recipients With History of ALD

NCT07397598 | Not Yet Recruiting DMC

• 2 other identifiers: IRB00466249P50AA027054
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Alcohol Use Disorder; Liver Transplant Recipient; Alcohol Related Liver Disease

Keywords

Alcohol use disorder; Alcohol Related Liver Disease; Liver transplant recipient; Peer support specialist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Liver Transplant Medical Treatment Engagement

  Up to 1 year

• Overall Post-Liver Transplant Survival

  Up to 1 year

Study Arms (1)

Peer Support Specialist (PSS)

EXPERIMENTAL

Behavioral: Peer Support

Interventions

Peer Support BEHAVIORAL

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.

Peer Support Specialist (PSS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Po-Hung Chen, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Po-Hung Chen, MD, PhD

CONTACT

410-550-1793; pchen37@jhmi.edu

Mary E. McCaul, PhD

CONTACT

410-955-9526; mmccaul1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)