Liver TransplantationSOCIAL-TXNCT04551742
Social & Contextual Impact on Children Undergoing Liver Transplantation
An observational study of Liver Transplantation and Liver Diseases, run by University of California, San Francisco at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Liver Transplantation, Liver Diseases
- How many people
- 500 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 Sep 2020to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Caregivers or parents of children undergoing liver transplantation Healthcare professionals caring for children undergoing liver transplantation
Who may be able to join
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Medical Center Dallas
Dallas, Texas, 75235
Children's Hospital Los Angeles
Los Angeles, California, 90027
Lucile Packard Children's Hospital
Palo Alto, California, 94304
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
University of California San Francisco
San Francisco, California, 94158
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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.
- Conditions
- Liver Transplantation, Liver Diseases
- Keywords
- Pediatric, Health services research, Social determinants of health
- Medical subject headings
- Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization
Measured: 90 Days
Episodes of acute cellular rejection
Measured: 1 Year
Ideal Outcome-3 (IO-3)
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.
Measured: 3 Years
Secondary outcomes (3)
Readmission within 90 days after transplant
Measured: 90 Days
Episode of biopsy-proven acute cellular rejection within 90 days after transplant
Measured: 90 Days
Episode of re-transplantation
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start16 Sep 2020
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharad Wadhwani, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551742
- Sponsor's protocol ID
- 19-29632
- Acronym
- SOCIAL-TX
- Status last verified
- Jan 2026
- First submitted
- 9 Sep 2020
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kelly M, Ali S, Huerta A, Hsu EK, Squires JE, Campbell KM, Gupta NA, Zielsdorf SM, Ebel NH, Bucuvalas JC, Lai JC, Wadhwani SI. Characterizing Barriers to Living Donor Liver Transplantation for Pediatric Recipients: Qualitative Results from the SOCIAL-Tx Study. J Pediatr. 2026 Jul;294:115112. doi: 10.1016/j.jpeds.2026.115112. Epub 2026 Apr 21.
PubMed 42025789
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social & Contextual Impact on Children Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT04551742
- Acronym / sponsor ID
- SOCIAL-TX / 19-29632
- Conditions
- Liver Transplantation, Liver Diseases
- Keywords
- Pediatric, Health services research, Social determinants of health
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Caregivers or parents of children undergoing liver transplantation Healthcare professionals caring for children undergoing liver transplantation
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization
Time frame: 90 Days
Episodes of acute cellular rejection
Time frame: 1 Year
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.
3 secondary outcomes
Readmission within 90 days after transplant
Time frame: 90 Days
Episode of biopsy-proven acute cellular rejection within 90 days after transplant
Time frame: 90 Days
Episode of re-transplantation
Time frame: 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Derived from this study: PubMed 42025789Kelly M, Ali S, Huerta A, Hsu EK, Squires JE, Campbell KM, Gupta NA, Zielsdorf SM, Ebel NH, Bucuvalas JC, Lai JC, Wadhwani SI. Characterizing Barriers to Living Donor Liver Transplantation for Pediatric Recipients: Qualitative Results from the SOCIAL-Tx Study. J Pediatr. 2026 Jul;294:115112. doi: 10.1016/j.jpeds.2026.115112. Epub 2026 Apr 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharad Wadhwani, MD, MPH principal investigator
University of California, San Francisco
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Liver Diseases, run by University of California, San Francisco at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization (time frame: 90 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04551742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.