Improving Access to Renal Transplantation for Underserved Black Communities

NCT06707038 | Withdrawn DMC

• 2 other identifiers: STU00223027U01DK137258-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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)

Keywords

Heath Services Research; Intervention

Outcome Measures

Primary Outcomes (1)

• Listing status for each Arm by month 12

  Listing (active or inactive) status by month 12

  12 months from time of enrollment

Secondary Outcomes (3)

• Quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) 1.2 Global Health Scale

  at enrollment and at 12 months after enrollment

• Self-Efficacy in Kidney Dialysis Management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)

  at enrollment and at 12 months after enrollment

• trust in care received by transplant team using Adapted Trust in Physicians Scale

  at enrollment and at 12 months after enrollment

Study Arms (2)

AATAP (intervention) Arm

EXPERIMENTAL

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

Behavioral: AATAP intervention

Standard of Care (Control) Arm

NO 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

Interventions

AATAP intervention 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

AATAP (intervention) Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identify as Black or African American;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Tampa General Hospital: collaborator

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniela Ladner, MD, MPH, FACS, FAST

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Northwestern University Transplant Outcomes Collaborative

Model Details: Investigators will use a 1:1 allocation ratio of randomization to intervention and control. Randomization will be stratified by sex (male, female) and age (divided into 2 categories). Participants will be assigned to a randomization group upon completing the eligibility screener and consent has been obtained, which will occur after the patient has attended the Roundtable visit and completed baseline questionnaires, but before their first visit with the center.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 27, 2024
• Study Start: April 1, 2025
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)