Implementation of a culturally competent <i>APOL1</i> genetic testing programme into living donor evaluation: A two-site, non-randomised, pre-post trial design.

Abstract

While living donor (LD) kidney transplantation is the optimal treatment for patients with kidney failure, LDs assume a higher risk of future kidney failure themselves. LDs of African ancestry have an even greater risk of kidney failure post-donation than White LDs. Because evidence suggests that Apolipoprotein L1 (<i>APOL1</i>) risk variants contribute to this greater risk, transplant nephrologists are increasingly using <i>APOL1</i> genetic testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counselling with LD candidates about <i>APOL1</i> due to a lack of knowledge and skill in counselling. Without proper counselling, <i>APOL1</i> testing will magnify LD candidates' decisional conflict about donating, jeopardising their informed consent. Given cultural concerns about genetic testing among people of African ancestry, protecting LD candidates' safety is essential to improve informed decisions about donating. Clinical 'chatbots', mobile apps that provide genetic information to patients, can improve informed treatment decisions. No chatbot on <i>APOL1</i> is available and no nephrologist training programmes are available to provide culturally competent counselling to LDs about <i>APOL1</i>. Given the shortage of genetic counsellors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice. Using a non-randomised, pre-post trial design in two transplant centres (Chicago, IL, and Washington, DC), we will evaluate the effectiveness of culturally competent <i>APOL1</i> testing, chatbot and counselling on LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate and satisfaction with informed consent and longitudinally evaluate the implementation of this intervention into clinical practice using the <u>R</u>each, <u>E</u>ffectiveness, <u>A</u>doption, <u>I</u>mplementation and <u>M</u>aintenance framework. This study will create a model for <i>APOL1</i> testing of LDs of African ancestry, which can be implemented nationally via implementation science approaches. <i>APOL1</i> will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve informed consent. This study involves human participants and was approved by Northwestern University IRB (STU00214038). Participants gave informed consent to participate in the study before taking part. ClinicalTrials.gov Identifier: NCT04910867. Registered 8 May 2021, https://register. gov/prs/app/action/SelectProtocol?sid=S000AWZ6&selectaction=Edit&uid=U0001PPF&ts=7&cx=-8jv7m2 ClinicalTrials.gov Identifier: NCT04999436. Registered 5 November 2021, https://register. gov/prs/app/action/SelectProtocol?sid=S000AYWW&selectaction=Edit&uid=U0001PPF&ts=11&cx=9tny7v.