Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04551742

Social & Contextual Impact on Children Undergoing Liver Transplantation

The social determinants of health have a large impact on health. For example, neighborhood socioeconomic deprivation is associated with increased risk of medication non-adherence, graft failure, and death in children after liver transplant. In order to address these socioeconomic inequities in outcomes, a more granular understanding of how the social determinants of health impact outcomes is needed. In this observational prospective cohort, caregivers of children undergoing liver transplantation will complete surveys and undergo in-depth, qualitative interviews. The survey will assess comprehensively for the social determinants of health (e.g. material economic hardship, health literacy, social connectedness, primary care quality, etc). The qualitative interviews will identify barriers and facilitators that socioeconomically deprived children/families have to obtaining the ideal outcome and identify health system opportunities to integrate social needs and medical care. Data will be linked to an existing prospective cohort study (The Society for Pediatric Liver Transplant registry) to assess the impact of social risk on outcomes after transplant.

Healthcare providers who take care of children undergoing liver transplant will also be included in the qualitative interviews. The goal of including this group in the study is to determine the health systems barriers and facilitators to social needs screening and intervention.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Caregivers/parents of children with the following criteria will be approached for inclusion in this study:

  • Children <18 years of age at the time of transplant
  • Undergoing liver transplantation
  • Guardian's consent, child assent (in accordance with each institution's IRB policies)
  • Consents to enrollment in SPLIT

Exclusion criteria

Caregivers/parents of children undergoing liver transplantation will be excluded it:

  • Caregiver unwilling or unable to complete the survey
  • Child 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
  • Non-US residents
  • Declined participation in SPLIT

Inclusion criteria

for Interview Portion of the Study:

  • Participants who have completed the questionnaire OR
  • Medical team member involved in the care of children undergoing liver transplant (e.g., physician, nurse, social worker)

Treatment and study plan

Primary outcomes

  1. Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization

    Time frame: 90 Days

  2. Episodes of acute cellular rejection

    Time frame: 1 Year

  3. Ideal Outcome-3 (IO-3)

    Time frame: 3 Years

    The ideal outcome measure is a composite measure of morbidity after transplant defined as alive, ALT and GGT <50, normal GFR, no non-liver transplants, no cytopenias, and no PTLD.

Secondary outcomes

  1. Readmission within 90 days after transplant

    Time frame: 90 Days

  2. Episode of biopsy-proven acute cellular rejection within 90 days after transplant

    Time frame: 90 Days

  3. Episode of re-transplantation

    Time frame: 3 Years

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: SOCIAL-TX

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2020
Registry last updated
Jan 26, 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.

Published trials that share one or more normalized conditions with this study.