APOL1 Genetic Testing Program for Living Donors, Part 2

NCT04999436 | Completed DMC

• 2 other identifiers: R01 DK128207 part 2R01DK128207
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating. No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice. The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to:

1. 1.Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice
2. 2.Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design
3. 3.Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs' satisfaction with informed consent.

Conditions

Chronic Kidney Diseases; Genetic Predisposition

Keywords

Implementation science; Ethics; African continental ancestry group; Culturally competent care; Shared decision making; Genetic couseling; Informed consent; Nephrology; Educational intervention; Surveys and questionnaires; Apolipoprotein L1

Outcome Measures

Primary Outcomes (2)

• Number and quality of prescribed Pre-Test counseling practices

  We will use an observer checklist to directly observe participating nephrologists' counseling discussions with live donor kidney transplant candidates' about APOL1 testing, and living donation (before APOL1 testing is done). The checklist will assess the presence/absence of prescribed counseling practices (fidelity) and a rating of each practice's quality (excellent, very good, good, fair, poor). The fidelity minimum and maximum values are: 0-12 Higher fidelity scores mean that the pre-test counseling discussion exhibited greater fidelity (adherence) to the training program. The quality minimum and maximum values are: 1-5 Higher quality scores mean a better quality counseling discussion.

  Post-intervention, up to 5 years

• Number and quality of prescribed Post-Test counseling practices

  We will use an observer checklist to directly observe participating nephrologists' counseling discussions with live donor candidates' about APOL1 test results and living donation (after APOL1 testing is done). The checklist will assess the presence/absence of prescribed counseling practices (fidelity) and a rating of each practice's quality (excellent, very good, good, fair, poor). The minimum and maximum values are: 0-12 Higher fidelity scores mean that the post-test counseling discussion exhibited greater fidelity (adherence) to the training program. The quality minimum and maximum values are: 1-5 Higher quality scores mean a better quality counseling discussion.

  Post-intervention, up to 5 years

Secondary Outcomes (12)

• Practical Knowledge and Self-Efficacy in Genetic Counseling

  Day 1

• Practical Knowledge and Self-Efficacy in Genetic Counseling

  Approximately Day 14

• Acceptability of Intervention Measure (AIM)

  Approximately Day 21

• Acceptability of Intervention Measure (AIM)

  Approximately Month 2

• Acceptability of Intervention Measure (AIM)

  Approximately Month 12

Other Outcomes (9)

• Racial attributes in clinical evaluation (RACE) scale

  Day 1

• Racial attributes in clinical evaluation (RACE) scale

  Approximately Day 14

• Genetic variation knowledge assessment index (GKAI)

  Day 1

Study Arms (1)

Counseling Training Program

EXPERIMENTAL

The APOL1 counseling training program is designed for transplant nephrologists who evaluate live kidney donor candidates of African ancestry who are at risk for having APOL1 risk variants and kidney failure post-donation. The training program aims to increase transplant nephrologists' practical knowledge, self-efficacy, and skills in counseling live donor candidates about APOL1 in a culturally competent manner. The program will include training in: current APOL1 data; the value of APOL1 testing and meaning of positive test results for living donor clinical evaluation; risks of having two APOL1 gene variants on the donor's kidney health; how to engage in shared decision making about donation; how to address cultural concerns about genetic testing; and how to protect donor candidates' privacy and confidentiality with APOL1 test results. The APOL1 counseling training program will be delivered by a genetic counselor through webinars and other interactive modalities and last 2-4 hours.

Behavioral: APOL1 Counseling Training Program

Interventions

APOL1 Counseling Training Program BEHAVIORAL

The APOL1 counseling training program is designed for transplant nephrologists who evaluate live kidney donor candidates of African ancestry who are at risk for having APOL1 risk variants and kidney failure post-donation. The training program aims to increase transplant nephrologists' practical knowledge, self-efficacy, and skills in counseling live donor candidates about APOL1 in a culturally competent manner. The program will include training in: current APOL1 data; the value of APOL1 testing and meaning of positive test results for living donor clinical evaluation; risks of having two APOL1 gene variants on the donor's kidney health; how to engage in shared decision making about donation; how to address cultural concerns about genetic testing; and how to protect donor candidates' privacy and confidentiality with APOL1 test results. The APOL1 counseling training program will be delivered by a genetic counselor through webinars and other interactive modalities and last 2-4 hours.

Counseling Training Program

Eligibility Criteria

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

You may qualify if:

• Adults (age 18 years and older)
• English-speaking
• Transplant nephrologists evaluating live kidney donor candidates practicing at the study sites
• Not vision impaired
• Not cognitively impaired

You may not qualify if:

• Not a nephrologist

Sponsors & Collaborators

• Northwestern University: lead
• Georgetown University: collaborator

Study Sites (2)

Medstar Georgetown Transplant Institute

Washington D.C., District of Columbia, 20007, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Smith JD, Agrawal A, Wicklund C, Duquette D, Friedewald J, Rasmussen LV, Gacki-Smith J, Tandon SD, Muhammad LN, Yancy CW, Dong S, Cooper M, Gilbert A, Shetty A, Gordon EJ. Implementation of a culturally competent APOL1 genetic testing programme into living donor evaluation: A two-site, non-randomised, pre-post trial design. BMJ Open. 2023 May 15;13(5):e067657. doi: 10.1136/bmjopen-2022-067657.

  PMID: 37188469 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Genetic Predisposition to Disease

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; Disease Susceptibility

Study Officials

• Elisa J Gordon, PhD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We will collect observational data to assess the impact of the training program on clinical practice. We will collect pre-test data before the intervention, and post-test data after the intervention.

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: August 10, 2021
• Study Start: July 19, 2022
• Primary Completion: January 17, 2025
• Study Completion: January 27, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)