Hybrid Community-Electronic Health Record Approaches to Apolipoprotein L1 Kidney Disease Screening and Clinical Trials among Black Individuals

Community engagement achieved high apolipoprotein L1 (APOL1)-mediated kidney disease screening rates but low yield of trial-eligible participants. Electronic health record and health care professional referrals identified more participants with APOL1 high-risk genotype and significant albuminuria. Hybrid community-electronic health record recruitment may improve equity and efficiency in APOL1-mediated kidney disease trial enrollment.

Black individuals bear a disproportionate burden of kidney diseases, including genetically mediated risk related to apolipoprotein L1 ( APOL1 ) gene variants. Awareness of APOL1-mediated kidney disease (AMKD) and participation in therapeutic trials remain low. Whether different engagement strategies can raise awareness and identify trial-eligible individuals is uncertain. The Community APOL1 Research Engagement (CARE) study aimed to increase AMKD awareness through culturally tailored education and screening while building a clinical trial-eligible registry, CARE Registry, to support a phase 2 baricitinib trial for AMKD in the Janus kinase-Signal Transducers and Activators of Transcription Inhibition to Reduce APOL1-Associated Kidney Disease.

The CARE study was conducted from May 2022 to July 2025 across community and clinical settings in multiple US regions, in partnership with churches with predominantly Black attendees. Black adults aged 18-70 years without diabetes or dialysis dependence underwent APOL1 genotyping and kidney disease screening. Recruitment occurred via community events, electronic health record (EHR) queries, physician referrals, and self-referrals. The primary outcome was eligibility for the CARE Registry, defined by APOL1 high-risk genotype, urine albumin-to-creatinine ratio ≥300 mg/g, and eGFR ≥25 ml/min per 1.73 m 2 .

Of 1052 individuals approached, 789 (75%) consented to screening. Overall, 128 (17%) carried APOL1 high-risk genotypes. Community events accounted for most enrollments (83%) but yielded low rates of registry-eligible albuminuria (1%). By contrast, EHR queries and physician referrals identified higher proportions of participants with APOL1 high-risk genotypes and urine albumin-to-creatinine ratio ≥300 mg/g. Twenty-four participants met CARE Registry criteria, and seven enrolled in the Janus kinase-Signal Transducers and Activators of Transcription Inhibition to Reduce APOL1-Associated Kidney Disease trial. Refusal was 4% and attrition was 2%.

Community engagement achieved high participation and awareness but was less efficient for identifying trial-eligible individuals than EHR- and health care professional-based approaches.

ClinicalTrial.gov, NCT05237388 .