Pediatric Liver Transplanted RecipientsHEAL-Tx:RCTNCT07279350
Health Advocate for Children After Liver Transplant
A study testing Health advocate in people with Pediatric Liver Transplanted Recipients, run by University of California, San Francisco at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pediatric Liver Transplanted Recipients
- What is being tested?
- Health advocate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 May 2026to 1 Aug 2030
- Phase
- Interventional
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Andrea Huerta contact
United States2 sites, 2 recruiting
- Recruiting
University of Pittsburgh Medical Center | Children Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Susan M Richey, RN, 412-692-6337, richeys@upmc.edu
James Squires, MD, MS
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Health Advocate for Children After Liver Transplant: A Hybrid Implementation Effectiveness RCT
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.
Read the detailed description
HEAL-Tx trial is a Type 1 hybrid effectiveness-implementation trial across 6 U.S. transplant centers (UCSF, Seattle Children's Hospital, Stanford University, Children's Healthcare of Atlanta, University of Pittsburgh, Children's Hospital of Colorado.) Children/families will be screened for material economic hardship as part of standard of care during their transplant hospitalization using the 10-question Accountable Healthcare Communities tool. Families who report material economic hardship will be approached for study participation, and those who consent will be randomized to either the control or treatment arm. Participants in the control arm will receive enhanced standard of care: they will receive a printed handout with a list of resources specific to their hardship and their home ZIP code. They will also receive a follow-up call at 45-days with a reminder of the suggested resources. Participants in the treatment arm will receive a customized 90-day Health Advocate intervention. Both the treatment and control arm group will complete a baseline interview and a close-out 90-day interview to assess outcomes and experiences with the intervention. The treatment arm will have one additional interview at the 45-day timepoint. Once both arms complete treatment, they will have data extracted from their medical records at the 1, and 2-year timepoint.
- Conditions
- Pediatric Liver Transplanted Recipients
- Being tested
- Health advocate, Enhanced Control
- Keywords
- pediatric liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health advocateBehavioural
Also called HA
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Advocate Intervention | Experimental | The caregiver will receive 90-days of tailored health advocate intervention Receives: Behavioral: Health advocate |
| Enhanced Control | Active comparator | 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. Receives: Behavioral: Enhanced Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-TCMR between 90 days and 2 years post-transplant using Kaplan-Meir plots.
After the perioperative period, it is an objective outcome closely linked with poor adherence/challenges with self-management. Investigators found strong associations between material economic hardship and TCMR episodes of TCMR increase risks of graft failure/death post-transplant and early TCMR increases risk of late TCMR and vulnerability to infections. All analyses will be intention-to-treat. Investigators will use Kaplan-Meier plots to descriptively compare survival distributions of the primary outcome (TCMR) by trial arm. We will compare time-to-TCMR between treatment arms using Cox regression. For participants recruited in years 1 \& 2 of the study period, we will collect 2 years of follow-up data. For participants recruited in year 3, we will apply administrative censoring after 1 year of follow up data.
Measured: Through study completion, an average of 1 year up to 2 years.
Secondary outcomes (7)
Measurement of incidence of Medication Level Variability Index >2.0 using generalized linear mixed effect models.
An MLVI >2.0 predicted late TCMR, even after accounting for other causes of tacrolimus fluctuations. In the first 6 months after transplant, tacrolimus levels can fluctuate based on physiological changes associated with transplant. After 6 months, fluctuations are most likely related to poor adherence. Investigators will measure the incidence of MLVI >2.0 between 6 months - 1 year, and 1year and 2 years. If a patient has an episode of TCMR within this time, investigators will only collect tacrolimus levels preceding this event. Investigators will calculate MLVI based on available levels for 6 months - 1 year, and for 1year - 2 years. Investigators will use generalized linear mixed effects models for dichotomous outcomes to analyze MLVI >2.0. Models will also include random effects for each patient, and fixed effects that include trial arm, time since randomization and site. If differences in groups are observed, interaction terms may be introduced to assess heterogeneity in trends.
Measured: Through study completion, an average of one year up to 2 years.
Change in Parent-Reported Social Needs Score From Baseline to 90 Days (SIREN-Informed PRO Measure)
Parent-reported social needs will be assessed using a SIREN-informed patient-reported outcome measure. Scores will be calculated at baseline and 90 days. Change scores will be compared between treatment arms using a t-test, and the primary analysis will use linear regression (ANCOVA) with the baseline score as a covariate to estimate the mean difference in change between groups.
Measured: Baseline and 90-days post enrollment
Liver inflammation (ALT or GGT >50) and overimmunosuppression (positive EBV or CMV PCR) at years 1 and 2 using linear mixed effects models.
Investigators will use generalized linear mixed effects models for dichotomous outcomes to analyze liver inflammation and overimmunosuppression. Models will include random effects for each patient, and fixed effects for trial arm, time since randomization (allowing investigators to assess trends), and site.
Measured: An average of 1 year up to 2 years.
Parent-Reported Social Service Utilization (Count of Services Received)
Parents will report whether social services were received in the 90-day period following enrollment. Investigators will summarize utilization using counts and percentages and compare across centers using chi-square tests.
Measured: 90-days post enrollment
Change in Parent-Reported Social Service Utilization From Baseline to 90 Days
Receipt of social services will be recorded at baseline and 90 days. The change in utilization will be compared between treatment arms using t-tests and modeled using ANCOVA with baseline utilization as a covariate.
Measured: Baseline and 90 days post-enrollment
Parent-Reported Social Needs Score at Baseline (SIREN-Informed PRO Measure)
Baseline social needs scores will be summarized using medians and quartiles for continuous measures.
Measured: Baseline
Parent-Reported Social Needs Score at 90 Days (SIREN-Informed PRO Measure)
Follow-up social needs scores at 90 days will be summarized and compared across centers using Kruskal-Wallis tests.
Measured: 90-days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start5 May 2026
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric Liver Transplanted RecipientsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 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
- NCT07279350
- Sponsor's protocol ID
- 24-41233
- Other IDs
- 5K23DK132454
- Acronym
- HEAL-Tx:RCT
- Status last verified
- Aug 2026
- First submitted
- 21 Oct 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monette S, Seguin L, Gauvin L, Nikiema B. Validation of a measure of maternal perception of the child's health status. Child Care Health Dev. 2007 Jul;33(4):472-81. doi: 10.1111/j.1365-2214.2006.00713.x.
PubMed 17584404Minkovitz CS, O'Campo PJ, Chen YH, Grason HA. Associations between maternal and child health status and patterns of medical care use. Ambul Pediatr. 2002 Mar-Apr;2(2):85-92. doi: 10.1367/1539-4409(2002)0022.0.co;2.
PubMed 11926838Witte J, Mehlis K, Surmann B, Lingnau R, Damm O, Greiner W, Winkler EC. Methods for measuring financial toxicity after cancer diagnosis and treatment: a systematic review and its implications. Ann Oncol. 2019 Jul 1;30(7):1061-1070. doi: 10.1093/annonc/mdz140.
PubMed 31046080
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Advocate for Children After Liver Transplant: A Hybrid Implementation Effectiveness RCT
- ClinicalTrials.gov ID
- NCT07279350
- Acronym / sponsor ID
- HEAL-Tx:RCT / 24-41233
- Conditions
- Pediatric Liver Transplanted Recipients
- Keywords
- pediatric liver transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 May 2026 (actual)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 12 Dec 2025 (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 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.
Detailed description
HEAL-Tx trial is a Type 1 hybrid effectiveness-implementation trial across 6 U.S. transplant centers (UCSF, Seattle Children's Hospital, Stanford University, Children's Healthcare of Atlanta, University of Pittsburgh, Children's Hospital of Colorado.) Children/families will be screened for material economic hardship as part of standard of care during their transplant hospitalization using the 10-question Accountable Healthcare Communities tool. Families who report material economic hardship will be approached for study participation, and those who consent will be randomized to either the control or treatment arm. Participants in the control arm will receive enhanced standard of care: they will receive a printed handout with a list of resources specific to their hardship and their home ZIP code. They will also receive a follow-up call at 45-days with a reminder of the suggested resources. Participants in the treatment arm will receive a customized 90-day Health Advocate intervention. Both the treatment and control arm group will complete a baseline interview and a close-out 90-day interview to assess outcomes and experiences with the intervention. The treatment arm will have one additional interview at the 45-day timepoint. Once both arms complete treatment, they will have data extracted from their medical records at the 1, and 2-year timepoint.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Advocate Intervention | Experimental | Behavioral: Health advocateThe caregiver will receive 90-days of tailored health advocate intervention |
| Enhanced Control | Active comparator | Behavioral: Enhanced ControlThe 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. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health advocateAlso: HAThe 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. | Behavioural | Health Advocate Intervention |
| Enhanced ControlCaregivers 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. | Behavioural | Enhanced Control |
Primary outcome
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.
After the perioperative period, it is an objective outcome closely linked with poor adherence/challenges with self-management. Investigators found strong associations between material economic hardship and TCMR episodes of TCMR increase risks of graft failure/death post-transplant and early TCMR increases risk of late TCMR and vulnerability to infections. All analyses will be intention-to-treat. Investigators will use Kaplan-Meier plots to descriptively compare survival distributions of the primary outcome (TCMR) by trial arm. We will compare time-to-TCMR between treatment arms using Cox regression. For participants recruited in years 1 \& 2 of the study period, we will collect 2 years of follow-up data. For participants recruited in year 3, we will apply administrative censoring after 1 year of follow up data.
7 secondary outcomes
Measurement of incidence of Medication Level Variability Index >2.0 using generalized linear mixed effect models.
Time frame: Through study completion, an average of one year up to 2 years.
Change in Parent-Reported Social Needs Score From Baseline to 90 Days (SIREN-Informed PRO Measure)
Time frame: Baseline and 90-days post enrollment
Liver inflammation (ALT or GGT >50) and overimmunosuppression (positive EBV or CMV PCR) at years 1 and 2 using linear mixed effects models.
Time frame: An average of 1 year up to 2 years.
Parent-Reported Social Service Utilization (Count of Services Received)
Time frame: 90-days post enrollment
Change in Parent-Reported Social Service Utilization From Baseline to 90 Days
Time frame: Baseline and 90 days post-enrollment
Parent-Reported Social Needs Score at Baseline (SIREN-Informed PRO Measure)
Time frame: Baseline
Parent-Reported Social Needs Score at 90 Days (SIREN-Informed PRO Measure)
Time frame: 90-days post enrollment
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 10 Aug 2026.
- Background: PubMed 17584404Monette S, Seguin L, Gauvin L, Nikiema B. Validation of a measure of maternal perception of the child's health status. Child Care Health Dev. 2007 Jul;33(4):472-81. doi: 10.1111/j.1365-2214.2006.00713.x.
- Background: PubMed 11926838Minkovitz CS, O'Campo PJ, Chen YH, Grason HA. Associations between maternal and child health status and patterns of medical care use. Ambul Pediatr. 2002 Mar-Apr;2(2):85-92. doi: 10.1367/1539-4409(2002)0022.0.co;2.
- Background: PubMed 31046080Witte J, Mehlis K, Surmann B, Lingnau R, Damm O, Greiner W, Winkler EC. Methods for measuring financial toxicity after cancer diagnosis and treatment: a systematic review and its implications. Ann Oncol. 2019 Jul 1;30(7):1061-1070. doi: 10.1093/annonc/mdz140.
- Related InfoLink provided by the sponsor.
- 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.
Andrea Huerta contact
Sharad Wadhwani, MD, MPH principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health advocate in people with Pediatric Liver Transplanted Recipients, run by University of California, San Francisco at 2 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 5 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Bethany Reyna, BA, CCRP (415-476-7748, Bethany.reyna@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). 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 NCT07279350, which also lists 3 linked publications.
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 10 Aug 2026.