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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn whether the African American Transplant Access Program can be successfully replicated at another large kidney transplant program. The main questions it aims to answer are: Does the AATAP intervention increase the number of Black patients who are listed for kidney transplant? Does the AATAP intervention have an effect on Black patient self-efficacy and trust in care team? Researchers will compare kidney transplant listing status after 12 months of patients in the AATAP intervention to usual care patients to see if the AATAP program increases the number of patients listed for transplant.

Research Team

Daniela P Ladner, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+