GUARDD Study

People of African ancestry (Blacks) have increased risk of kidney failure due to numerous socioeconomic, environmental, and clinical factors. Two variants in the APOL1 gene (GeneID: 8542) are now thought to account for much of the racial disparity associated with hypertensive kidney failure in Blacks. One in 7 AAs carry this risk allele, but it is nearly absent in other populations; the variants protect against infection with African trypanosomiasis which is endemic to Africa. However, this knowledge has not been translated into clinical care to help improve patient outcomes and address disparities. It is unknown whether patient or clinician knowledge of genetic risk impacts patient care (i.e., renal surveillance, BP medication use/intensification) or outcomes such as BP control and CKD. GUARDD is a randomized trial to evaluate the effects and challenges of incorporating genetic risk information into primary care. Hypertensive, nondiabetic, adults with self-reported African ancestry, without kidney dysfunction, are recruited from diverse clinical settings and randomized to undergo APOL1 genetic testing at baseline (intervention) or at one year (waitlist control). Prior to enrolling their patients, providers are educated about genomics and APOL1. Guided by a genetic counselor, trained staff return APOL1 results to patients and provide low-literacy educational materials. Real-time clinical decision support tools alert clinicians of their patients' APOL1 results and associated risk status at the point of care. Our academic - community clinical partnership designed a study to generate information about the impact of genetic risk information on our primary outcome - patient care (renal surveillance by clinicians, of serum creatinine and/or urine albumin tests. with a sub-aim of reduction of systolic blood pressure). Secondary outcomes include impact on primary outcomes at 12 months, psycho-behavioral differences of patients between groups and over time, clinician knowledge, attitudes and beliefs at baseline and 12 months, and differences in outcomes between those tested and not tested. GUARDD will help establish the effective implementation of APOL1 risk informed management of hypertensive patients at high risk of CKD, and will provide a robust framework for future endeavors to implement genomic medicine in diverse clinical practices. It will also add to the important dialog about factors that contribute to and may help eliminate racial disparities in kidney disease. ]]>
Eligibility based on EHR and phone screener: Non-Diabetic Hypertensive: 2+ readings over 140/80 at least six months apart, and/or taking a prescription for anti-hypertensive medication and/or an ICD-9 code for hypertension (401.XX, 402.XX and 405.XX) Self-Identified African-American/Black or having African Ancestry Sees a primary care provider at a GUARDD site (within past 2 years) Age 18 -70 Community Dwelling Exclusion Criteria: Diabetes CKD (GFR<60) Pregnant Non-English speaking Planning to move out of the NYC area during the study period Cognitive impairment ]]>
A qualitative pilot study, conducted from September 2013 - December 2013 informed the conceptual framework, design and implementation of the RCT. Between November 2014 and November 2016, 2052 individuals of self-reported African ancestry were enrolled in GUARDD. Height, weight and blood pressure were measured and a survey administered at baseline, 3 month and 12 month follow-up. ]]>