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NCT Number: NCT07397598

Peer Support for Liver Transplant Recipients With History of ALD

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Alcohol Consumption

    Time frame: Up to 1 year

    Any use or excessive use (i.e., >7/>14 drinks per week for women/men) by biomarker or self-report

Secondary outcomes

  1. Liver Transplant Medical Treatment Engagement

    Time frame: Up to 1 year

    Proportion of kept/scheduled LT follow-up medical appointments

  2. Overall Post-Liver Transplant Survival

    Time frame: Up to 1 year

    All-cause mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Mary E. McCaul, PhD

CONTACT

[email protected]

410-955-9526

Po-Hung Chen, MD, PhD

CONTACT

[email protected]

410-550-1793

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: THRIVE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 9, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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