Genetic Testing to Understand and Address Renal Disease Disparities

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care

Conditions
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Hypertension, Chronic Kidney Disease, Genomics

Intervention / Treatment
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* Other: Immediate Genetic Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages18-65 Self-identifies as Black/African American History of hypertension Patient at a participating site Exclusion Criteria: History of Chronic Kidney Disease History of Diabetes Pregnant Cognitively impaired/unable to provide consent Terminally ill Planning to leave area of study permanently during the one year study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Genetic Testing<br>Participants randomized to intervention will receive the APOL1 genetic test upon study enrollment. | Other: Immediate Genetic Testing<br>* 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.<br>* Other names: Genetic Risk Communication;|
| No Intervention: Control- Delayed Testing<br>Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 12 months | 
| Change in Systolic Blood Pressure | Change in systolic blood pressure at 3 months as compared to baseline | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Change in Medication Adherence | Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization | 3 months | 
| Number of Patients With Changes in Psychosocial Behaviors | Number of patients with changes in psychosocial behaviors 3 months after randomization | 3 months | 
| Number of Participants With Attitude Towards Genetic Testing | Patient attitude towards genetic testing 3 months after randomization | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Chronic Kidney Disease, End Stage Renal Disease, APOL1, Genomics, Genetics, Community-engaged