Integrating a Culturally Competent APOL1 Genetic Testing Program Into Living Donor Evaluation
Trial ID: NCT04910867
Status: ACTIVE_NOT_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-09-09
Completion date: 2026-03-31
Sponsor: Northwestern University
Collaborators: Georgetown University
Conditions: Chronic Kidney Diseases; Apolipoprotein L1; Kidney Transplantation
Interventions: Components of Genetic Counseling; APOL1 genetic testing; EHR integration
Locations: Medstar Georgetown Transplant Institute; Northwestern University Feinberg School of Medicine
Countries: United States; United States
Enrollment: 206
Age range: 18 Years - None
Sex: ALL

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 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 practice
2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design
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.

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.

Eligibility criteria:
Inclusion Criteria:

* Living kidney donor candidates who identify as African American/Black, Jamaican, Barbadian, Grenadian, Brazilian from Salvador Trinidadian, Panamanian, Honduran, Haitian, Garifunan, Palenque, Guyanese, Dominican, Peruvian, Belizean, and Native American, or state that they have African ancestry or are aware of having biologically-related family with African ancestry
* Living kidney donor candidates may be directed or non-directed donors
* Adults (ages 18+)
* English-speaking
* Cognitively intact individuals
* All genders

Exclusion Criteria:

* Individuals who do not identify as African American/Black and are not aware of having any biologically-related family with African ancestry and do not have African ancestry
* Only African Americans and people of African ancestry will be included because APOL1 risk variants are predominantly found in African Americans and people who have African ancestry.
* Pregnant women cannot be living kidney donors

Outcomes:
Decisional Conflict Scale (DCS); Decisional Conflict Scale (DCS); Decisional Conflict Scale (DCS); Decisional Conflict Scale (DCS)