APOL1 Genetic Testing and Counseling Does Not Reduce Living Kidney Donors’ Willingness to Donate: A Hybrid Type 2 Non-Randomized Controlled Trial

BACKGROUND: Living donors of African ancestry have the highest risk of post-donation kidney disease. Apolipoprotein L1 (APOL1) risk variants may contribute to this risk. This study evaluated the effectiveness and implementation of our culturally appropriate APOL1 Testing and Counseling Program to reduce potential donors' decisional conflict for donation. METHODS: This prospective, non-randomized, pre-post two-site hybrid type 2 effectiveness-implementation study evaluated the impact of the intervention on decisional conflict about donation, preparedness for decision making about donation and for donation, willingness to donate, and satisfaction with informed consent among potential donors of African ancestry undergoing evaluation. The intervention involved donors: using a chatbot providing APOL1 information, receiving culturally competent counseling, and APOL1 genetic testing. Control arm received routine care. We used the RE-AIM framework to longitudinally evaluate implementation outcomes assessed via validated surveys with donors and electronic health record review using linear mixed effects models. Cross-sectional outcomes were assessed using multiple regression models. RESULTS: We enrolled 280 potential donors (75 control arm, 205 intervention arm) (71.07% participation rate). More were female (59%) and had a mean age of 40.2 years (standard deviation [SD] 12.8). No significant differences emerged in most primary and secondary outcomes between the intervention and control groups (decisional conflict Beta (95% CI): -1.05 (-4.13, 2.03), P=0.50), preparation for decision making (Beta (95% CI): -7.02 (-18.83, 4.78); P=0.24), preparedness to donate (Beta (95% CI): 0.04 (-0.48, 0.56); P=0.89), willingness to donate (Beta (95% CI): 0.18 (-0.29, 0.66), P=0.45). The right amount of information to make a decision domain for satisfaction with informed consent was significantly lower in the intervention arm (Beta (95% CI): -0.34 (-0.65, -0.02), P=0.04). CONCLUSIONS: Our APOL1 Testing and Counseling Program had no effect on potential donors' willingness to donate regardless of undergoing APOL1 testing, demonstrating the feasibility of its integration into routine donor clinical evaluation.