Improving Access to Renal Transplantation for Underserved Black Communities (AATAP)

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Transplant; ESRD (End Stage Renal Disease)
• Intervention / Treatment: Behavioral: AATAP intervention

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Listing status for each Arm by month 12	Listing (active or inactive) status by month 12	12 months from time of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) 1.2 Global Health Scale	Scoring/T-Score Metric: The T-score metric is standardized with a mean of 50 and a standard deviation (SD) of 10. This means a T-score of 50 represents the average score of the reference population, and each 10-point deviation represents one standard deviation above or below the mean. Minimum and Maximum Values: The T-score typically ranges from 20 to 80, though this can vary slightly depending on the specific population and scoring method used. Interpretation: Higher T-scores indicate better health outcomes, while lower T-scores indicate worse health outcomes.	at enrollment and at 12 months after enrollment
Self-Efficacy in Kidney Dialysis Management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)	Scoring: The PKDSMS uses an average score on a five-point Likert scale, where respondents rate their self-management abilities. Minimum and Maximum Values: The scale ranges from 1 to 5, with 1 indicating low self-efficacy and 5 indicating high self-efficacy. Interpretation: Higher scores indicate better self-management and higher confidence in managing kidney dialysis.	at enrollment and at 12 months after enrollment
trust in care received by transplant team using Adapted Trust in Physicians Scale	Scoring: This scale typically uses a five-point Likert format, where respondents rate their level of agreement with various statements about their trust in their physicians. The response options range from "strongly disagree" to "strongly agree". Minimum and Maximum Values: The scale ranges from 1 to 5, with 1 indicating low trust and 5 indicating high trust. Interpretation: Higher scores indicate greater trust in the transplant team, while lower scores indicate less trust.	at enrollment and at 12 months after enrollment

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Tampa General Hospital
• Investigators: Principal Investigator: Daniela Ladner, MD, MPH, FACS, FAST, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): May 6, 2025
• Study Completion (Actual): May 6, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Intervention; Heath Services Research
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: STU00223027; U01DK137258-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No