Recruiting

HEAL-Tx

Sponsor:

UCLA

Code:

NCT07279350

Conditions

Pediatric Liver Transplanted Recipients

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Health advocate

Enhanced Control

Study Details

Brief summary:

The HEAL-Tx is a 90-day intervention, in which a Health Advocate works with eligible families to identify and apply for community-based resources, alert healthcare providers to challenges the family is encountering, and guide health system navigation (e.g., coordinating appointments). Families in the control arm will receive a printed handout that provides contact information for local community-based resources. Families in the treatment arm will receive HEAL-Tx.

Conditions

Pediatric Liver Transplanted Recipients

Study ID

NCT07279350

Start date

May 5, 2026

Status verified date

Aug, 2026

Completion date

Aug 1, 2030

Anticipated

Primary completion date

Aug 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient <18 years old at the time of liver transplant
  • Received a liver transplant within past 90 days
  • Family endorses material economic hardship on 10-questions Accountable Healthcare Communities screening tool.
  • Will receive follow-up care for at least 2 years
  • Family can read or write English or Spanish
  • A Legally Authorized Representative (LAR) can provide consent, and for children (12-17 years of age, the child is willing/able to provide assent.)
  • Family has a working phone and smartphone device capable of receiving calls or virtual visits via Zoom.

Exclusion Criteria:

  • Patient has severe cognitive impairment.
  • 18 years of age or older at the time of consent
  • Patient unwilling or unable to consent/participate
  • Patient is a ward of the state (e.g. foster care) since present circumstances may not be reflective of child's past or future circumstances.
  • Non-English, non-Spanish speakers as ICFs, HIPAA authorization form, surveys, and interviews will only be available in these 2 languages. Languages besides English and Spanish are excluded from this study.

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Health Advocate Intervention

The caregiver will receive 90-days of tailored health advocate intervention

active comparator: Enhanced Control

The caregiver will receive a printed sheet of resources once and a follow-up call at the 45-day timepoint with a reminder of the suggested resources.

Interventions

Health advocate

The health advocate is a trained individual who is not a part of the medical team. They work directly with the caregivers of patients who have received a liver transplantation to assist them with navigating the healthcare system, find resources, and relay any concerns to their medical team. They work with an assigned family for 90-days and tailor their intervention to meet the families social needs.

Enhanced Control

Caregivers in the control arm will receive enhanced standard of care: they will be given a handout with a list of resources specific to their hardship and their home ZIP code. They will receive a follow-up call at 45 days with a reminder of the suggested resources.

Primary outcome measure

  • Time-to-TCMR between 90 days and 2 years post-transplant using Kaplan-Meir plots. [ Time Frame: Through study completion, an average of 1 year up to 2 years. ]

Central Contacts and Locations

Central contacts

Bethany Reyna, BA, CCRP

415-476-7748Bethany.reyna@ucsf.edu

Andrea Huerta

andrea.huerta2@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

University of Pittsburgh Medical Center | Children Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Susan M Richey, RN

412-692-6337richeys@upmc.edu

Principal Investigator:

James Squires, MD, MS

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • pediatric liver transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-10.