In this genomic medicine implementation pilot project, the investigators aim to conduct a randomized trial in a network of community health centers and primary care facilities to study processes, effects and challenges of incorporating information for apolipoprotein L1 (APOL1)-attributable genetic risk for end stage kidney disease in patients of African ancestry with hypertension .
CKD is most commonly associated with diabetes (40%) and hypertension (28%), and affects 26 million American adults. African ancestry populations with hypertension (HTN) have 2- to 3-fold higher risk of developing CKD, and a 5-fold increased risk to progress to end stage renal disease (ESRD) when compared with whites. HTN is a risk factor for progression of CKD and for increased cardiovascular risk with CKD. Thus targeting blood pressure control as a modifiable risk factor may both reduce CVD in people with CKD and reduce progression of CKD to end stage disease. Recent discoveries demonstrate that testable alleles of the APOL1 locus on chromosome 22 have a major effect on and explain almost all of the excess risk for hypertension-associated CKD and its progression to ESRD in African ancestry populations. We will use community-engaged approaches to enroll patients of African Ancestry with HTN from a network of community health centers and primary care facilities in Harlem and the Bronx and randomize them on a 7 to 1 ratio to receive APOL1 genetic testing and EMR-enabled provider clinical decision support incorporating APOL1 genomic risk information.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,052
Participants will receive the APOL1 genetic test. Trained research staff will meet with participants to communicate results and lifetime ESRD risk attributable to variations in the APOL1 gene. Primary care providers will receive APOL1 genetic risk information via a best practice alert in the participant's EMR upon commencement of a patient encounter and through results filed in the participant's genetics results section of their EMR.
Institute for Family Health
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Number of Participants With Urine Protein Excretion
Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline
Time frame: Baseline and 12 months
Change in Systolic Blood Pressure
Change in systolic blood pressure at 3 months as compared to baseline
Time frame: Baseline and 3 months
Number of Participants With Change in Medication Adherence
Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization
Time frame: 3 months
Number of Patients With Changes in Psychosocial Behaviors
Number of patients with changes in psychosocial behaviors 3 months after randomization
Time frame: 3 months
Number of Participants With Attitude Towards Genetic Testing
Patient attitude towards genetic testing 3 months after randomization
Time frame: 3 months
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