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The VA is the largest single provider of HIV care in the US and Veterans with HIV use significantly more healthcare services and have a 1.5-2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The goal is to improve BP treatment for Veterans with HIV to reduce ASCVD risk. Within a randomized controlled trial (RCT), the investigators hypothesize that the VA adapted nurse-led intervention will result in a clinically significant 6 millimeters of mercury (mmHg) reduction in systolic blood pressure (SBP) over 12 months compared to those receiving enhanced education only. The study is innovative because of the use of stakeholder-engaged design process, multi-component nurse-led intervention, and VA Video Connect (VVC) to monitor CVD risk factors. The project meets VA strategic priorities including: 1) greater choice for Veterans; 2) improve timeliness of services; 3) focus more resources more efficiently (strengthen foundational services in VA). If shown to be effective, this intervention will have substantial impact among high-risk Veterans, potentially reducing ASCVD events by more than a quarter.
Background: The VA is the largest provider of HIV care in the United States. The ~31,000 Veterans with HIV use significantly more healthcare and have up to 2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The HIV treatment cascade model includes care steps; once people obtain remission, providers should focus on preventing ASCVD. The investigators will extend the HIV treatment cascade and focus on reducing ASCVD risk among people with HIV. Veterans with HIV have low perceived risk for ASCVD and uptake of guideline-based treatment for BP is low.
Significance/Impact: The proposed intervention has the potential to reduce ASCVD events in this population by more than a quarter and meet VA strategic priorities of: 1) improve timeliness of services; 2) focus resources more efficiently as well as address health systems research (HSR) research priorities: 1) patient centered care, care management, and health promotion; 2) healthcare access; 3) aging; 4) virtual care.
Innovation: The study is innovative: Cascade Model. By leveraging the HIV treatment cascade model, the investigators will create a pathway for ASCVD risk reduction to be added into widespread quality improvement initiatives. Stakeholder-engaged design process. The investigators will employ stakeholder-engaged research methods to ensure the intervention meets the needs of patients and healthcare providers. Multi-component nurse-led intervention. While each of the components of the intervention have an evidence base, they have not been tested together in an HIV context. Telehealth. The investigators will use VA Video Connect (VVC) to monitor CVD risk factors.
Specific Aims: Aim 1a: Conduct qualitative interviews with Veterans and healthcare providers to ascertain perceptions regarding HIV and CVD risk reductions to inform intervention adaptation.
Aim 1b: Adapt the intervention to the VA HIV clinic context with key stakeholder input.
Aim 2: Evaluate the 12-month efficacy of a nurse intervention to improve systolic blood pressure in Veterans with HIV. Hypothesis: The investigators hypothesize that the intervention will result in a clinically significant 6mmHg reduction in SBP over 12 months compared to those receiving [enhanced education + usual care] only. Aim 3: Conduct an evaluation of the prevention nurse intervention. Exploratory aim: If effective, [the investigators will conduct a budget impact analysis] and simulate 10-year cost-effectiveness of the nurse intervention.
Methodology: The investigators will conduct qualitative interviews with care team and Veterans to adapt the intervention in an iterative design process. The investigators will then conduct a RCT to evaluate an intervention to reduce ASCVD risk. The study will be conducted in 3 clinics among HIV+ Veterans (n=300) on suppressive antiretroviral therapy (ART) with confirmed SBP >140 mmHg, stratified by clinic site and randomized 1:1 to intervention vs. education control. The intervention will involve 4 evidence-based components based on the investigators' prior studies and adapted to Veterans with HIV: (1) nurse-led care coordination, (2) nurse-managed medication and adherence support (3) home BP monitoring, and (4) administered VA Video Connect (VVC). The education control will receive enhanced education and usual care. Primary outcome: difference in 12-month systolic BP in the intervention arm vs control. Secondary outcome: 12-month difference in non-HDL cholesterol. The investigators will use a mixed-methods design to evaluate fidelity, dose delivered/received, reach, recruitment, and context of the intervention.
Implementation/Next Steps: The investigators designed the intervention with downstream implementation in view. This includes: a fully remote delivery of the intervention to facilitate access and widespread implementation, and guidance for selection of nurses with education / experience levels that match those of health coaches delivering interventions within the VA. The investigators will work with operational partners from the Office of Connected Care and Office of HIV/AIDS care regarding implementation plans. The investigators will disseminate a clinical program, including scripts, and description of all intervention processes, to facilitate implementation within the VA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months. |
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| Education control group | Active Comparator | Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group | Behavioral | This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist) |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews. | Baseline |
| Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews. | 4 months |
| Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews. | 8 months |
| Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Non-HDL Cholesterol | Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL) | Baseline |
| Non-HDL Cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hayden B Bosworth, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Puja Van Epps, MD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033-4004 | United States | ||
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37278662 | Result | Schexnayder J, Perry KR, Sheahan K, Majette Elliott N, Subramaniam S, Strawbridge E, Webel AR, Bosworth HB, Gierisch JM. Team-Based Qualitative Rapid Analysis: Approach and Considerations for Conducting Developmental Formative Evaluation for Intervention Design. Qual Health Res. 2023 Jul;33(8-9):778-789. doi: 10.1177/10497323231167348. Epub 2023 Jun 6. | |
| 37800987 |
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Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication and study results will be available on Clinical Trials.gov within 1 year of the final follow-up with last study participant. A local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI) prior to distribution. Data will be provided to requester in electronic form. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access.
Data will be available within 1 year of the final follow-up with the last study participant.
Guidance on request and distribution processes will be provided by the VA Office of Research and Development (ORD).
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While 305 participants were consented and randomized to an arm, 4 withdrew and did not complete the baseline assessment.
301 is the number that completed baseline assessment and will therefore be used as the baseline analytic population for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months. Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2024 | Aug 1, 2025 |
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| Education control group | Behavioral | This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months. |
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Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
| 4 months |
| Non-HDL Cholesterol | Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL) | 8 months |
| Non-HDL Cholesterol | Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL) | 12 months |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States |
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | United States |
| Musoke L, Bosworth HB, Dickson C, Gentry P, Strawbridge E, Subramaniam S, Gierisch J, Smith V, Woolson S, Pura J, Amutuhaire W, Naggie S, Schexnayder J, Hall K, Longenecker CT, Harris NM, Rogers C, Van Epps P; for V-EXTRA-CVD Group. A telehealth-delivered intervention to extend the veteran HIV treatment cascade for cardiovascular disease prevention: V-EXTRA-CVD study protocol for a randomized controlled trial. HIV Res Clin Pract. 2023 Dec;24(1):2261747. Epub 2023 Oct 6. |
| FG001 | Education Control Group | Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction. Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months. Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist) |
| BG001 | Education Control Group | Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction. Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews. | The randomized participants who completed the baseline assessment | Posted | Mean | Standard Deviation | mmHg | Baseline |
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| Primary | Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews. | Enrolled participants who attended the in-person 4 month outcome assessment visit and had BP taken by study personnel. | Posted | Mean | Standard Deviation | mmHg | 4 months |
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| Primary | Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews. | Enrolled participants who attended the in-person 8 month outcome assessment visit and had BP taken by study personnel. | Posted | Mean | Standard Deviation | mmHg | 8 months |
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| Primary | Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews. | Enrolled participants who attended the in-person 12 month outcome assessment visit and had BP taken by study personnel. | Posted | Mean | Standard Deviation | mmHg | 12 months |
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| Secondary | Non-HDL Cholesterol | Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL) | The number of enrolled participants who visited the lab during their outcome assessment period and had blood lipids measured. | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Secondary | Non-HDL Cholesterol | Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL) | The number of enrolled participants who visited the lab during their 4 month outcome assessment period and had blood lipids drawn. | Posted | Mean | Standard Deviation | mg/dL | 4 months |
| ||||||||||||||||||||||||||||||
| Secondary | Non-HDL Cholesterol | Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL) | The number of enrolled participants who visited the lab during their 8 month outcome assessment period and had blood lipids drawn. | Posted | Mean | Standard Deviation | mg/dL | 8 months |
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| Secondary | Non-HDL Cholesterol | Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL) | The number of enrolled participants who visited the lab during their 12 month outcome assessment period and had blood lipids drawn. | Posted | Mean | Standard Deviation | mg/dL | 12 months |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months. Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist) | 3 | 152 | 18 | 152 | 0 | 152 |
| EG001 | Education Control Group | Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction. Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months. | 1 | 149 | 16 | 149 | 0 | 149 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Acute knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Chest pain hospitalization | Cardiac disorders | Non-systematic Assessment |
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| Congestive Heart Failure Exacerbation | Cardiac disorders | Non-systematic Assessment |
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| COVID hospitalization | Infections and infestations | Non-systematic Assessment |
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| Defibrillator placement | Cardiac disorders | Non-systematic Assessment |
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| Elective surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Falls | General disorders | Non-systematic Assessment |
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| Gallbladder-related hospitalization | Hepatobiliary disorders | Non-systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Inpatient rehab | Social circumstances | Non-systematic Assessment |
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| Iron deficiency anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Lithotripsy | Surgical and medical procedures | Non-systematic Assessment |
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| Liver biopsy | Hepatobiliary disorders | Non-systematic Assessment |
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| Orthostasis | General disorders | Non-systematic Assessment |
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| Osteomyelitis | Infections and infestations | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Prostatectomy | Surgical and medical procedures | Non-systematic Assessment |
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| Psychiatric admission | Psychiatric disorders | Non-systematic Assessment |
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| Renal failure/injury | Renal and urinary disorders | Non-systematic Assessment |
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| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| UTI | Renal and urinary disorders | Non-systematic Assessment |
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| Stent placement | Cardiac disorders | Non-systematic Assessment |
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| Death | General disorders | Non-systematic Assessment |
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Recruitment challenges led to adjustments in inclusion criteria prior to study start, which affected baseline systolic blood pressure levels. The study was designed to evaluate systolic blood pressure (SBP) outcomes, not exploratory subgroup analyses.
The generalizability is limited to VA-based HIV populations.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hayden Bosworth, PhD | Durham VA Health Care System | 919-286-0411 | 177101 | Hayden.Bosworth@va.gov |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2025 | Aug 1, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2022 | Oct 16, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Some college or trade school |
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| College graduate or higher |
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| Unemployed |
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| Retired |
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