Improving Access to Renal Transplantation for Underserved Black Communities

NCT ID: NCT06707038

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-05-06

Brief Summary

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.

Conditions

Kidney Transplant; ESRD (End Stage Renal Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

AATAP (intervention) Arm

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 Type: EXPERIMENTAL

AATAP intervention

Intervention Type: BEHAVIORAL

AATAP is a program created to address the barriers that Black patients face when accessing transplantation. AATAP providers resources in cultural congruency, trust, psychosocial support, and health literacy to provide patients with the individualized support needed to access the kidney transplant waitlist

Standard of Care (Control) Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AATAP intervention

AATAP is a program created to address the barriers that Black patients face when accessing transplantation. AATAP providers resources in cultural congruency, trust, psychosocial support, and health literacy to provide patients with the individualized support needed to access the kidney transplant waitlist

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• self-identify as Black or African American;
• 18 to 75 years of age
• have an eGFR < 20 or End Stage Renal Disease Diagnosis;
• 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

Exclusion Criteria

• other racial groups
• participants who have previously received a transplant;
• pregnant women;
• participants who screen negative on the screener;
• children less than 18 years old

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Tampa General Hospital

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Daniela Ladner

Director, Northwestern University Transplant Outcomes Collaborative

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Ladner, MD, MPH, FACS, FAST

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Tampa General Hospital

Tampa, Florida, United States

Countries

United States

Other Identifiers

U01DK137258-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00223027

Identifier Type: -

Identifier Source: org_study_id