Peer Navigation + Kidney Transplant Fast Track for Improving Access to Kidney Transplants in Minority Populations

(AKT-MP Trial)

Overseen By Nila S Judd, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Children, Waitlisted, Prior transplant, Incarcerated, Pregnant, Infection, Cancer, Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

398 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Hispanic/Latino and American Indian patients with kidney failure access kidney transplants more easily. Researchers are comparing two methods: a fast-track evaluation process (Kidney Transplant Fast Track, KTFT) and a peer-assisted program (Peer Navigation, PN), to determine which method helps more people complete their transplant evaluations and receive a transplant. This could improve access to transplants and reduce disparities among different groups. Individuals undergoing kidney transplant evaluation at the University of New Mexico, who are mentally competent and have not had a prior kidney transplant or certain medical conditions, are suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance transplant access for diverse communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these methods are safe for improving access to kidney transplants?

Research has shown that the Kidney Transplant Fast Track (KTFT) program aims to reduce racial and ethnic disparities in access to kidney transplants. Although specific safety data is unavailable, KTFT is not a drug or surgery. It is an administrative process designed to expedite transplant evaluations, suggesting it is likely safe.

For Peer Navigation (PN), studies indicate that this method involves trained peers assisting patients through the complex kidney transplant evaluation process. While specific safety data is lacking, PN focuses on guidance and support, which suggests it is also likely safe.

Both KTFT and PN aim to simplify and improve access to the transplant process, particularly for minority groups facing more challenges in obtaining transplants. Since these approaches enhance systems rather than involve direct medical treatments, they are likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve kidney transplant access for minority populations through innovative approaches. Unlike traditional methods that often involve complex and lengthy processes, the Kidney Transplant Fast Track (KTFT) aims to streamline and expedite the transplant pathway, potentially reducing wait times and increasing access. Meanwhile, the Peer Navigation (PN) approach offers personalized guidance and support from individuals who have experienced the transplant process themselves, addressing cultural and informational barriers that often hinder minority patients. Together, these strategies could significantly enhance the likelihood of successful kidney transplants for underserved groups, making the trial a promising endeavor for improving health equity.

What evidence suggests that this trial's treatments could be effective for improving access to kidney transplants in minority populations?

This trial will compare two approaches: the Kidney Transplant Fast Track (KTFT) program and Peer Navigation (PN). Studies have shown that the KTFT program increases the likelihood of being added to the waitlist and receiving a kidney transplant, helping patients move through the transplant process more quickly. Research also indicates that centers using KTFT have successfully transplanted more minority patients and improved their survival rates.

Peer Navigation involves former transplant recipients assisting new patients through the process, making the evaluation process easier and less overwhelming. Both methods in this trial aim to reduce barriers for patients seeking a kidney transplant, particularly within Hispanic/Latino and American Indian communities. ^{1 2 3 4 6}

Who Is on the Research Team?

Larissa Myaskovsky, PhD

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

This trial is for adults over 18 with kidney disease, specifically Hispanic/Latino and American Indian patients at the University of New Mexico. They must be mentally competent and not currently waitlisted at another center or have had a previous kidney transplant. Pregnant women, children under 18, incarcerated individuals, those with recent non-skin cancer or cognitive impairments are excluded.

Inclusion Criteria

I am mentally capable of making my own decisions.

Undergoing kidney transplant evaluation at the University of New Mexico

Exclusion Criteria

I am under 18 years old.

I have had a kidney transplant.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the Kidney Transplant Fast Track (KTFT) or Peer Navigator (PN) intervention to facilitate kidney transplant evaluation

1 year

Follow-up

Participants are monitored for quality of life and ambivalence towards kidney transplant using PROMIS Scale and Decisional Conflict Scale

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Kidney Transplant Fast Track (KTFT)
• Peer Navigation (PN)

Trial Overview The study compares two methods to help overcome barriers to getting a kidney transplant: a streamlined evaluation process (KTFT) and peer-assisted support (PN). Participants will be randomly assigned to one of these approaches to see which is more effective and cost-efficient in aiding them through the transplant evaluation process.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

PN

Group II: Arm 1 Experimental Treatment 1 Intervention

KTFT

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Published Research Related to This Trial

A multilevel quality improvement program significantly improved access to kidney transplants (KTX) for African Americans (AAs) in South Carolina, as evidenced by increased equity in evaluations and waitlisting for transplants from 2017 to 2021.

The Kidney Transplant Equity Index (KTEI) showed notable improvements, with the KTEI for initiated evaluations rising from 0.89 in 2017 to 1.00 in 2021, indicating a reduction in disparities in access to KTX for AAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilevel Intervention to Improve Racial Equity in Access to Kidney Transplant. Taber, DJ., Su, Z., Gebregziabher, M., et al.[2023]

Patients from high-risk communities (with a community risk score of 0-40) showed a 22% increased risk of mortality and were less likely to receive living donor transplants, indicating that community factors significantly impact kidney transplant outcomes.

The study analyzed data from 209,198 adult candidates listed for transplantation between 2004-2010, revealing that community risk influences not only waitlist dynamics but also the likelihood of receiving preemptive listings and the type of donor kidneys available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prominent impact of community risk factors on kidney transplant candidate processes and outcomes. Schold, JD., Heaphy, EL., Buccini, LD., et al.[2023]

The Kidney Transplant Equity Index (KTEI) is a new metric that measures how well kidney transplant centers provide access to transplants for minority patients, revealing significant disparities in transplant practices across 249 centers from 2013 to 2018.

High KTEI centers not only transplanted more minority patients but also showed improved patient survival rates, indicating that equitable access to transplants can be achieved without compromising outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Kidney Transplant Equity Index: Improving Racial and Ethnic Minority Access to Transplantation. Delman, AM., Turner, KM., Silski, LS., et al.[2022]

A randomized controlled trial involving 401 patients showed that a transplant center-based patient navigator did not significantly increase overall waitlisting rates for kidney transplants (32% for intervention vs. 26% for control) but had a notable impact after 500 days, where intervention patients were 3.3 times more likely to be waitlisted.

The navigator also led to a higher number of living donor inquiries (18% vs. 10% in control), indicating that while the immediate effects on waitlisting were limited, the intervention may encourage more patients to consider living donation options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transplant Center Patient Navigator and Access to Transplantation among High-Risk Population: A Randomized, Controlled Trial. Basu, M., Petgrave-Nelson, L., Smith, KD., et al.[2023]

The study introduces a new metric called the waitlisting rate, which measures the number of patients waitlisted for kidney transplants relative to those referred for evaluation, providing a more comprehensive view of transplant program performance.

Analysis of data from 2012 to 2016 across nine Southeastern transplant programs revealed significant variability in waitlisting rates, indicating that this new metric could highlight disparities in access to transplant programs that are not captured by traditional transplant rate metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kidney transplant program waitlisting rate as a metric to assess transplant access. Paul, S., Melanson, T., Mohan, S., et al.[2023]

Racial-ethnic minorities in the U.S. face significant barriers to receiving living donor kidney transplants (LDKT), resulting in lower rates of transplantation compared to majority populations.

The review outlines a conceptual framework of these barriers, which include issues related to potential recipients and donors, healthcare providers, health system structures, and community factors, while also highlighting current initiatives aimed at addressing these disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding and overcoming barriers to living kidney donation among racial and ethnic minorities in the United States. Purnell, TS., Hall, YN., Boulware, LE.[2022]

Citations

1. hsc.unm.edu hsc.unm.edu/medicine/departments/internal-medicine/academic-divisions/nephrology/chek-d/_files/jamainternal_myaskovsky_2025_oi_250002_1741294437.83993.pdf

Kidney Transplant Fast Track and Likelihood of Waitlisting ... Meaning This study found that KTFT was associated with a higher likelihood of waitlisting and kidney transplant.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9562954/

Protocol for the AKT-MP trial: Access to Kidney ... The results of this trial will provide key information for facilitating the evaluation process, improving patient care, and decreasing disparities in KT.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04615819

Access to Kidney Transplantation in Minority Populations The AKT-MP study will assess whether Kidney Transplant Fast Track (KTFT), a streamlined KT evaluation process, or peer navigators (PN) who were former KT ...

4. withpower.com withpower.com/trial/phase-kidney-diseases-9-2021-3749e

Peer Navigation + Kidney Transplant Fast Track for ... High KTEI centers not only transplanted more minority patients but also showed improved patient survival rates, indicating that equitable access to transplants ...

5. amjtransplant.org amjtransplant.org/article/S1600-6135(25)02504-3/fulltext

Enhancing Kidney Transplant Evaluation: Barriers and ... We compared two approaches to enhance evaluation: Peer Navigators (PN; former KT recipients employing Motivational Interviewing) versus Fast Track (FT; ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04615819/access-to-kidney-transplantation-in-minority-populations

Access to Kidney Transplantation in Minority Populations Hispanic/Latino (HL) and American Indian (AI) patients are more likely than whites to have kidney failure, but less likely to complete ...