Liver Transplant; ComplicationsHEAL-Tx:ToCNCT06386198
HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients
A study testing Health Advocate in people with Liver Transplant; Complications, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Liver Transplant; Complications
- 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
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2024to 30 Jun 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient has received a liver transplant >1 year ago
- Study team has screened patient and discussed with the primary transplant practitioner that patient may benefit from the Health Advocate program.
- Patient has an unmet social risk (e.g., food insecurity) or MLVI >/= 2.0.
- Patient will be transferred to adult transplant team in <6 months.
- Patient can read and write English or Spanish
- Patient is between 18-25 years old and can provide informed consent.
- Patient has a working phone and smart device capable of video and/or audio virtual visits via Zoom.
Who cannot join
- Patient has significant cognitive impairment.
- Does not meet age criteria
- Patient is a ward of the state.
- Non-English, non-Spanish speakers.
- Non-US residents.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30345
Saira Ali, 404-849-3903, Saira.ali@choa.org
Nitika Gupta
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Emily Stekol, 415-502-3190, emily.stekol@ucsf.edu
Sharad Wadhwani, MD, MPH
About this study
The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM.
- Conditions
- Liver Transplant; Complications
- Being tested
- Health Advocate
- Keywords
- Health Advocate, Patient Navigator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health AdvocateBehavioural
Also called Patient Navigator
The Health Advocate intervention will include helping pediatric liver transplant recipients and their families address unmet household social needs (e.g., food insecurity), improve patient-provider communication, and enhance care coordination.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is a single arm pilot intervention. Receives: Behavioral: Health Advocate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patient experience
The investigators will administer a survey of patient experience at study enrollment and at the end of the intervention to assess for changes in patient experience with the transplant team. These questions will focus on experiences receiving transplant care, experiences discussing social needs with the transplant team, and overall subjective assessment of the transplant recipient's overall health.
Measured: Baseline and 180 days
Secondary outcomes (3)
Change in medication adherence using MLVI
Medication level variability index (MLVI) defined as the standard deviation of at least 3 outpatient tacrolimus trough levels (binary >/=2.0 or <2.0). The investigators will assess this at study entry and again at 180 days.
Measured: Baseline and 180 days
The quality of health advocate interactions with the participants, healthcare team, and community-based resources.
The Health Advocate will keep a detailed journal entry after each encounter and certain Health Advocate interactions will be recorded. The investigators will qualitatively analyze these journal entries and recordings to identify what functions the health advocate undertook.
Measured: 180 days
A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention.
The investigators will conduct in-depth interviews with the patient participant and clinical team members to assess overall satisfaction with the intervention.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start3 Mar 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Transplantation
- Responsible party
- Sponsor
- Investigators
- Sharad Wadhwani, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386198
- Sponsor's protocol ID
- 23-40699
- Acronym
- HEAL-Tx:ToC
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT06386198
- Acronym / sponsor ID
- HEAL-Tx:ToC / 23-40699
- Conditions
- Liver Transplant; Complications
- Keywords
- Health Advocate, Patient Navigator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Society of Transplantation
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 26 Apr 2024 (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 Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health AdvocateThis is a single arm pilot intervention. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient has received a liver transplant >1 year ago
- Study team has screened patient and discussed with the primary transplant practitioner that patient may benefit from the Health Advocate program.
- Patient has an unmet social risk (e.g., food insecurity) or MLVI >/= 2.0.
- Patient will be transferred to adult transplant team in <6 months.
- Patient can read and write English or Spanish
Key exclusion criteria (5 listed)
- Patient has significant cognitive impairment.
- Does not meet age criteria
- Patient is a ward of the state.
- Non-English, non-Spanish speakers.
- Non-US residents.
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: Patient NavigatorThe Health Advocate intervention will include helping pediatric liver transplant recipients and their families address unmet household social needs (e.g., food insecurity), improve patient-provider communication, and enhance care coordination. | Behavioural | Intervention |
Primary outcome
Changes in patient experience
Time frame: Baseline and 180 days
The investigators will administer a survey of patient experience at study enrollment and at the end of the intervention to assess for changes in patient experience with the transplant team. These questions will focus on experiences receiving transplant care, experiences discussing social needs with the transplant team, and overall subjective assessment of the transplant recipient's overall health.
3 secondary outcomes
Change in medication adherence using MLVI
Time frame: Baseline and 180 days
The quality of health advocate interactions with the participants, healthcare team, and community-based resources.
Time frame: 180 days
A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention.
Time frame: 180 days
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 11 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Liver Transplant; Complications
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
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.
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 Liver Transplant; Complications, 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 11 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 Sharad Wadhwani, MD, MPH (510-428-3058, sharad.wadhwani@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patient experience (time frame: Baseline and 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.