Access Program for Kidney Transplant

(AATAP Trial)

Overseen By Harika Reddy, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Other racial groups, Previous transplant, Pregnant, others

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

Compensation: Varies

Number of Visits: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program designed to help African American patients access kidney transplants can be successfully implemented at another large transplant center. Researchers seek to discover whether this program increases the number of Black patients listed for a transplant and enhances their confidence and trust in their healthcare team. The trial includes two groups: one receiving specialized care with a culturally matched team and another receiving standard care. Individuals who identify as Black or African American, have severe kidney issues (such as very low kidney function or kidney failure), and face specific challenges like low health literacy may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve transplant access and healthcare experiences for African American patients.

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 the African American Transplant Access Program is safe?

Research has shown that the African American Transplant Access Program (AATAP) is dedicated to improving access to kidney transplants for Black patients. The program offers a supportive care team and resources to build trust and understanding. As AATAP is not a medical treatment, it lacks specific safety data. The program focuses on overcoming barriers to healthcare access rather than on medical procedures or drugs, so no safety concerns are known.

The program primarily aims to enhance communication and support, which patients generally find helpful. It includes meetings with healthcare providers, support from a social worker, and efforts to boost health knowledge and psychological support. These activities are designed to be safe and supportive, enhancing patient experiences without causing physical side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the African American Transplant Access Program because it offers a unique, culturally tailored approach to kidney transplant care. Unlike the standard care, which involves separate visits to various specialists, this program provides a unified clinic visit with a racially concordant care team. This approach focuses on cultural congruency, trust-building, and enhanced health literacy, which are crucial for improving access and outcomes in African American communities. By integrating psychological support and addressing specific social determinants of health, the program aims to improve patient satisfaction and transplant success rates.

What evidence suggests that the African American Transplant Access Program is effective for increasing kidney transplant listings for Black patients?

Research has shown that the African American Transplant Access Program (AATAP), which participants in this trial may receive, can significantly improve kidney transplant access for Black patients. One study found a 55% increase in evaluations of Black patients and an 18% increase in the number of these patients listed for transplant after the program began. The program succeeds by focusing on cultural understanding, building trust, enhancing health knowledge, and providing emotional support. By standardizing evaluation processes and utilizing online health services, AATAP effectively addresses disparities in transplant access. These findings suggest that AATAP could increase the number of Black patients listed for kidney transplants and enhance their trust and confidence in their healthcare team. ^{1 5 6 7 8}

Who Is on the Research Team?

Daniela P Ladner, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for Black individuals with kidney failure who are potential candidates for a kidney transplant. The study aims to see if the African American Transplant Access Program (AATAP) helps more Black patients get on the transplant list, and if it boosts their confidence and trust in their healthcare team.

Inclusion Criteria

Screen positive for AATAP via the screener (for poor health literacy or poor medical adherence or psychosocial concerns)

Medically eligible to begin transplant evaluation process determined by transplant team

My kidney function is very low or I have end-stage kidney disease.

Exclusion Criteria

Other racial groups

Pregnant women

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the AATAP intervention receive one clinic visit with all transplant providers, a racially concordant care team, and dedicated social worker support. This includes cultural congruency, trust, health literacy, and psychological support. Questionnaires are administered.

12 months

1 visit (in-person) with ongoing support

Control

Participants in the standard of care arm have separate visits with nephrologists, surgeons, and social workers. This arm follows the common standard of care at the site. Questionnaires are administered.

12 months

Multiple visits (in-person)

Follow-up

Participants are monitored for changes in kidney transplant listing status, quality of life, self-efficacy, and trust in care team.

12 months

Assessments at enrollment and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• African American Transplant Access Program

Trial Overview The trial is testing the effectiveness of AATAP by comparing two groups: one receiving the AATAP intervention and another getting usual care. After 12 months, researchers will check if there's an increase in the number of patients listed for a kidney transplant among those who participated in AATAP.

How Is the Trial Designed?

Group I: AATAP (intervention) Arm Experimental Treatment 1 Intervention

One clinic visit with all transplant providers, racially concordant care team, dedicated social worked. This will incorporate: Cultural congruency, trust, health literacy and psychological support. Questionnaires also to be administered

Group II: Standard of Care (Control) Arm Active Control 1 Intervention

Separate visits with nephologist, surgeons and social worker. This arm will follow common standard of care at the site. Questionnaires also to be administered

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Tampa General Hospital

Collaborator

Trials

22

Recruited

4,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11526762/

The African American Transplant Access Program Kidney transplantation is the best long-term therapy for patients with ESKD, as it results in better survival, improved quality of life, and decreased cost to ...

2. srtr.org srtr.org/media/1872/mckinney-transplantation-2025-access-to-transplant-for-african-american-and-latino-patients-under-the-2014.pdf

Access to Transplant for African American and Latino ... Improving access to kidney transplantation without decreasing graft survival: long-term outcomes of blood group A2/A2B deceased donor kidneys in B recipients.

3. feinberg.northwestern.edu feinberg.northwestern.edu/research/podcast/The-Northwestern-Medicine-African-American-Transplant-Access-Program-with-Dinee-Simpson-MD.html

The Northwestern Medicine African American Transplant ... "Once the program had been in place for about a year, we saw a 55 percent increase in evaluations of Black patients and an 18 percent increase ...

4. facs.org facs.org/media-center/press-releases/2023/reducing-disparities-in-kidney-transplant-access/

Reducing disparities in kidney transplant access | ACS Study shows kidney transplant inequity among African Americans can be addressed by standardizing the evaluation process and expanding the use of telehealth.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522143297

Kidney Transplant in Black Recipients: Are African ... Even though there has been a dramatic improvement in both patient and graft survival after kidney transplantation, significant racial disparities adversely ...

6. researchprotocols.org researchprotocols.org/2024/1/e57784

Multifaceted Intervention to Improve Graft Outcome ... Based on national data, African American recipients have nearly twice the risk of graft loss at 5 years after transplant, when compared with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2451959625000113

Improving access to minorities with A2 to B kidney ... Studies have shown that A2 kidney transplants for blood group B recipients offer comparable graft and patient survival rates to ABO-compatible transplants.

8. mayoclinic.org mayoclinic.org/medical-professionals/transplant-medicine/news/mayo-clinic-experts-hope-new-race-neutral-kidney-transplant-listing-criteria-improve-access-for-black-individuals/mac-20540334

Transplant Medicine According to the National Kidney Foundation, African Americans are more than three times as likely to experience kidney failure than white ...