APOL1 Genetic Testing for Kidney Disease
Trial Summary
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of APOL1 genetic testing for kidney disease?
Is APOL1 genetic testing safe for humans?
How is APOL1 genetic testing different from other treatments for kidney disease?
APOL1 genetic testing is unique because it identifies genetic variants that increase the risk of kidney disease, particularly in individuals with African ancestry, rather than treating the disease directly. This testing helps in assessing the risk and guiding decisions in kidney transplantation, unlike traditional treatments that focus on managing symptoms or slowing disease progression.13478
What is the purpose of this trial?
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 APOL1 is 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 APOL1 testing 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. Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design3. 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.The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then be implemented nationally via implementation science approaches. APOL1 will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve patient informed consent.
Research Team
Elisa J Gordon
Principal Investigator
Northwestern University
Eligibility Criteria
This trial is for cognitively intact, English-speaking adults of African descent, including a wide range of nationalities like African American/Black, Jamaican, and others who are considering becoming living kidney donors. It's not for those without African ancestry or pregnant women.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants in the intervention group use the chatbot for 5-7 minutes and provide a saliva sample for APOL1 genetic testing
Counseling
Transplant nephrologists engage in a counseling discussion with donor candidates about APOL1 and living donation
Follow-up
Participants are monitored for decisional conflict, preparedness, willingness to donate, and satisfaction with informed consent
Treatment Details
Interventions
- APOL1 genetic testing
- Components of Genetic Counseling
- EHR integration
APOL1 genetic testing is already approved in United States, European Union for the following indications:
- Risk assessment for kidney disease in living donors of African ancestry
- Risk assessment for kidney disease in living donors of African or Caribbean heritage
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Georgetown University
Collaborator