Liver TransplantationTAP-LTNCT05080595
Transportation Assistance Program for Liver Transplant
A study testing Transportation assistance (Lyft rides) in people with Liver Transplantation, run by University of Southern California at 1 site in United States.
Trial summary
We propose a rideshare-supported intervention that leverages a partnership with Lyft Health, a HIPAA-secured logistics solution that enables us to provide reliable and efficient transportation for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Transportation assistance (Lyft rides)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 2 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18+)
- Attended Phase 1 or Phase 1/2 Liver Transplant clinic visit
Who cannot join
- Unable to provide informed consent
- Pregnant women or prisoners
- Deemed ineligible for liver transplantation during initial evaluation visit
- Not referred for Phase 2 visit at the time of Phase 1 visit among those with initial Phase 1 visit only
- Hospitalized at the time of initial Phase 1 or Phase1/2 visit
- No access to handheld or landline telephone
- Residence outside of 60 miles from Keck Hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck Transplant Clinic
Los Angeles, California, 90033
About this study
Official title: Pilot Randomized Controlled Trial of a Need-Based Transportation Assistance Program in Liver Transplant Candidates
We propose a rideshare-supported intervention that leverages a partnership with Lyft Health, a HIPAA-secured logistics solution that enables us to provide reliable and efficient transportation for patients. Lyft rides will be provided to patients for any transplant-related medical visits, including but not limited to clinic visits with transplant providers, laboratory testing, and imaging/procedural testing that need to be performed as part of the routine evaluation process and prior to waitlisting for transplant.
Read the detailed description
Transportation barriers are often cited as barriers to healthcare access, leading to delays in care, non-compliance, and lower health outcomes. We hypothesize that access to transportation is a key modifiable social determinant that, if intervened upon, will lead to improvements in equitable access to the liver transplant waitlist (and transplant) for underserved liver transplant candidates.
We propose a rideshare-supported intervention that leverages a partnership with Lyft Health, a HIPAA-secured logistics solution that enables us to provide reliable and efficient transportation for patients. Lyft rides will be provided to patients for any transplant-related medical visits, including but not limited to clinic visits with transplant providers, laboratory testing, and imaging/procedural testing that need to be performed as part of the routine evaluation process and prior to waitlisting for transplant.
Aim 1 is to ascertain the prevalence of transportation barriers among liver transplant candidates and describe the sociodemographic and clinical characteristics of this population. Aim 2 is to pilot a randomized controlled trial of the needs-based app-supported transportation assistance program (TAP-LT) intervention. We will also assess preliminary efficacy, feasibility, patient acceptability, and cost of the intervention. We will conduct a prospective observational survey study (Aim 1) and pilot randomized controlled trial (Aim 2) at a single liver transplant program (Keck Liver Transplant Program at Keck Medical Center).
For the interventional trial, we will have three arms (Figure 2). Participants who report transportation barriers will be randomized 1:1 to either TAP-LT intervention or usual care (no transportation resources or assistance provided). Additionally, participants who report a reliable source of transportation will be included as a secondary control. In this pilot trial, we will enroll 20 participants in each of the three arms. We anticipate initiation of recruitment within 2 months of study approval, recruitment over approximately 6 months, with 6-12 months of intervention and follow-up with the goal of at least 90 days of follow-up after the end of intervention period for all recruited participants. The target population is adult liver transplant candidates who do not have a reliable source of transportation for their healthcare-related visits and needs. We will include adult patients who are eligible for liver transplantation and attend an initial outpatient evaluation visit.
The primary endpoint is the proportion of liver transplant candidates who report barriers to transportation. We will compare sociodemographic and clinical characteristics stratified by transportation status using Chi-square or t-test/Kruskal-Wallis as appropriate. Predictors of transportation barriers will be assessed with univariate and multivariate logistic regression. The primary outcome (time to listing for transplant waitlisting) will be a time-to-event outcome and we will examine the effect of the TAP-LT intervention with intention-to-treat Fine and Gray competing risk regression based on treatment arm. Secondary outcomes will be compared using Chi-square or t-test/Kruskal-Wallis as appropriate.
- Conditions
- Liver Transplantation
- Being tested
- Transportation assistance (Lyft rides)
- Keywords
- transportation, health services, intervention trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transportation assistance (Lyft rides)Other
Lyft rides will be provided to patients for any transplant-related medical visits
| Study group | Role | What they receive |
|---|---|---|
| Transportation assistance, reports unreliable transportation | Experimental | Lyft rides provided to transplant-related appointments Receives: Other: Transportation assistance (Lyft rides) |
| No transportation assistance, reports unreliable transportation | No intervention | No intervention, standard-of-care |
| Transportation assistance, control | No intervention | No intervention, standard-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to waitlisting for liver transplant
The primary outcome will be time to waitlisting for liver transplant, defined as time (in days) from initial evaluation visit date to date of official listing for liver transplant in the United Network for Organ Sharing database.
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Proportion with reported transportation barriers
Number of patients who report transportation barriers vs those who don't will be obtained from our transportation barriers survey
Measured: 1 year
Proportion waitlisted/transplanted
Proportion waitlisted/transplanted will be obtained from medical records
Measured: through study completion, an average of 1 year
Number of no-shows/cancellations
Number of no-shows/cancellations will be obtained from medical records
Measured: through study completion, an average of 1 year
Number of hospitalizations
Number of hospitalizations will be obtained from medical records
Measured: through study completion, an average of 1 year
Time to transplant
Time to transplant will be obtained from medical records
Measured: through study completion, an average of 1 year
Patient survival at 90 days
Vital status will be obtained from medical records
Measured: through study completion, an average of 1 year
Ride-related data among intervention participants
Number of rides, distance/commute time, cost
Measured: through study completion, an average of 1 year
Patient satisfaction with care
Measured by patient satisfaction survey
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start24 Jan 2022
- Primary completion27 Nov 2023
- Study completion2 Aug 2024
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kali Zhou, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080595
- Sponsor's protocol ID
- HS-21-00576
- Acronym
- TAP-LT
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou K, Wong C, Almanza J, Chen A, Kahn J, Ahearn A, Terrault N. A pilot randomized controlled trial of a transportation assistance program in liver transplant (TAP-LT) candidates. Liver Transpl. 2026 Aug 1;32(8):1148-1156. doi: 10.1097/LVT.0000000000000832. Epub 2026 Feb 18.
PubMed 41705818
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of a Need-Based Transportation Assistance Program in Liver Transplant Candidates
- ClinicalTrials.gov ID
- NCT05080595
- Acronym / sponsor ID
- TAP-LT / HS-21-00576
- Conditions
- Liver Transplantation
- Keywords
- transportation, health services, intervention trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 18 Oct 2021 (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.
We propose a rideshare-supported intervention that leverages a partnership with Lyft Health, a HIPAA-secured logistics solution that enables us to provide reliable and efficient transportation for patients. Lyft rides will be provided to patients for any transplant-related medical visits, including but not limited to clinic visits with transplant providers, laboratory testing, and imaging/procedural testing that need to be performed as part of the routine evaluation process and prior to waitlisting for transplant.
Detailed description
Transportation barriers are often cited as barriers to healthcare access, leading to delays in care, non-compliance, and lower health outcomes. We hypothesize that access to transportation is a key modifiable social determinant that, if intervened upon, will lead to improvements in equitable access to the liver transplant waitlist (and transplant) for underserved liver transplant candidates.
We propose a rideshare-supported intervention that leverages a partnership with Lyft Health, a HIPAA-secured logistics solution that enables us to provide reliable and efficient transportation for patients. Lyft rides will be provided to patients for any transplant-related medical visits, including but not limited to clinic visits with transplant providers, laboratory testing, and imaging/procedural testing that need to be performed as part of the routine evaluation process and prior to waitlisting for transplant.
Aim 1 is to ascertain the prevalence of transportation barriers among liver transplant candidates and describe the sociodemographic and clinical characteristics of this population. Aim 2 is to pilot a randomized controlled trial of the needs-based app-supported transportation assistance program (TAP-LT) intervention. We will also assess preliminary efficacy, feasibility, patient acceptability, and cost of the intervention. We will conduct a prospective observational survey study (Aim 1) and pilot randomized controlled trial (Aim 2) at a single liver transplant program (Keck Liver Transplant Program at Keck Medical Center).
For the interventional trial, we will have three arms (Figure 2). Participants who report transportation barriers will be randomized 1:1 to either TAP-LT intervention or usual care (no transportation resources or assistance provided). Additionally, participants who report a reliable source of transportation will be included as a secondary control. In this pilot trial, we will enroll 20 participants in each of the three arms. We anticipate initiation of recruitment within 2 months of study approval, recruitment over approximately 6 months, with 6-12 months of intervention and follow-up with the goal of at least 90 days of follow-up after the end of intervention period for all recruited participants. The target population is adult liver transplant candidates who do not have a reliable source of transportation for their healthcare-related visits and needs. We will include adult patients who are eligible for liver transplantation and attend an initial outpatient evaluation visit.
The primary endpoint is the proportion of liver transplant candidates who report barriers to transportation. We will compare sociodemographic and clinical characteristics stratified by transportation status using Chi-square or t-test/Kruskal-Wallis as appropriate. Predictors of transportation barriers will be assessed with univariate and multivariate logistic regression. The primary outcome (time to listing for transplant waitlisting) will be a time-to-event outcome and we will examine the effect of the TAP-LT intervention with intention-to-treat Fine and Gray competing risk regression based on treatment arm. Secondary outcomes will be compared using Chi-square or t-test/Kruskal-Wallis as appropriate.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transportation assistance, reports unreliable transportation | Experimental | Other: Transportation assistance (Lyft rides)Lyft rides provided to transplant-related appointments |
| No transportation assistance, reports unreliable transportation | No intervention | –No intervention, standard-of-care |
| Transportation assistance, control | No intervention | –No intervention, standard-of-care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (18+)
- Attended Phase 1 or Phase 1/2 Liver Transplant clinic visit
Key exclusion criteria (7 listed)
- Unable to provide informed consent
- Pregnant women or prisoners
- Deemed ineligible for liver transplantation during initial evaluation visit
- Not referred for Phase 2 visit at the time of Phase 1 visit among those with initial Phase 1 visit only
- Hospitalized at the time of initial Phase 1 or Phase1/2 visit
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 |
|---|---|---|
| Transportation assistance (Lyft rides)Lyft rides will be provided to patients for any transplant-related medical visits | Other | Transportation assistance, reports unreliable transportation |
Primary outcome
Time to waitlisting for liver transplant
Time frame: through study completion, an average of 1 year
The primary outcome will be time to waitlisting for liver transplant, defined as time (in days) from initial evaluation visit date to date of official listing for liver transplant in the United Network for Organ Sharing database.
8 secondary outcomes
Proportion with reported transportation barriers
Time frame: 1 year
Proportion waitlisted/transplanted
Time frame: through study completion, an average of 1 year
Number of no-shows/cancellations
Time frame: through study completion, an average of 1 year
Number of hospitalizations
Time frame: through study completion, an average of 1 year
Time to transplant
Time frame: through study completion, an average of 1 year
Patient survival at 90 days
Time frame: through study completion, an average of 1 year
Ride-related data among intervention participants
Time frame: through study completion, an average of 1 year
Patient satisfaction with care
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 41705818Zhou K, Wong C, Almanza J, Chen A, Kahn J, Ahearn A, Terrault N. A pilot randomized controlled trial of a transportation assistance program in liver transplant (TAP-LT) candidates. Liver Transpl. 2026 Aug 1;32(8):1148-1156. doi: 10.1097/LVT.0000000000000832. Epub 2026 Feb 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transportation assistance (Lyft rides) in people with Liver Transplantation, run by University of Southern California at 1 site 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to waitlisting for liver transplant (time frame: through study completion, an average of 1 year). 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 NCT05080595, 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 4 May 2026.