Pathways to Cardiovascular Disease Prevention (DCRI Central and Statistical Coordinating Center)
NCT ID: NCT04025125
Last Updated: 2025-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
2039 participants
OBSERVATIONAL
2014-01-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Eligibility Criteria
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Inclusion Criteria
1. Race equals Black/African-American, American Indian/Alaska Native, Asian, Native Hawaiian/Pacific Islander, or More than one race, and/or Ethnicity equals Hispanic or Latino;
2. Documented evidence of HIV positive status (HIV positive diagnosis (ICD10 codes B20-B24, or ICD9 codes 042, V08) and prescription of antiretroviral therapy (ART));
3. Documented evidence of elevated AtheroSclerotic CardioVascular Disease risk (ACC/AHA ASCVD 10 year risk ≥5%24, or Framingham Cardiovascular Disease 10 year risk ≥5%25) after HIV diagnosis. The date when the patient first meets either of these CVD risk thresholds and with 1 prior encounter not having CVD risk score defines the index time-point for Aim 1 of this study. These risk calculations depend on sex, age, body mass index, diabetes, current smoking, total cholesterol, HDL cholesterol, systolic blood pressure, and treatment for hypertension (defined from diagnosis codes). If cholesterol measures are not available, then body mass index may be used in place of lipids in the Framingham risk calculation; NOTE: must have a prior encounter within 365 days within health system prior to index
4. Presence of a modifiable risk factor: hypertension, diabetes, elevated total cholesterol, elevated LDL cholesterol and/or tobacco use.
Exclusion Criteria
2. Pre-existing ASCVD prior to index event, including a previous diagnosis of any acute myocardial infarction, heart failure, acute coronary syndromes, stable or unstable angina, arterial revascularization (includes coronary arterial or peripheral), stroke, transient ischemic attack or peripheral arterial disease presumed to be of atherosclerotic origin determined by ICD codes;
3. Encounter with cardiology specialist within 1 year prior to index
4. Evidence of ART for pre-exposure prophylaxis (i.e., Truvada \[emtricitabine/tenofovir disoproxil fumarate\] or post-exposure prophylaxis (e.g., Truvada plus raltegravir) without HIV diagnosis.
40 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Gerald Bloomfield, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Duke University
Durham, North Carolina, United States
Countries
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References
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Muiruri C, Corneli A, Cooper L, Dombeck C, Gray S, Longenecker CT, Meissner EG, Okeke NL, Pettit AC, Swezey T, Vicini J, Bloomfield GS. Perspectives of HIV specialists and cardiologists on the specialty referral process for people living with HIV: a qualitative descriptive study. BMC Health Serv Res. 2022 May 9;22(1):623. doi: 10.1186/s12913-022-08015-0.
Bloomfield GS, Hill CL, Chiswell K, Cooper L, Gray S, Longenecker CT, Louzao D, Marsolo K, Meissner EG, Morse CG, Muiruri C, Thomas KL, Velazquez EJ, Vicini J, Pettit AC, Sanders G, Okeke NL. Cardiology Encounters for Underrepresented Racial and Ethnic Groups with Human Immunodeficiency Virus and Borderline Cardiovascular Disease Risk. J Racial Ethn Health Disparities. 2024 Jun;11(3):1509-1519. doi: 10.1007/s40615-023-01627-0. Epub 2023 May 9.
Durstenfeld MS, Hill CL, Clare RM, Chiswell K, Sanders G, Gray S, Vicini J, Marsolo K, Okeke NL, Meissner EG, Thomas KL, Morse CG, Bloomfield GS, Pettit AC, Longenecker CT. Association of Cardiologist Clinic Visits With Cardiovascular Primary Prevention Outcomes Among People With HIV From Underrepresented Racial and Ethnic Groups in the Southern United States. J Am Heart Assoc. 2025 Mar 18;14(6):e038462. doi: 10.1161/JAHA.124.038462. Epub 2025 Mar 7.
Muiruri C, Dombeck C, Swezey T, Gonzales S, Lima M, Gray S, Vicini J, Pettit AC, Longenecker CT, Meissner EG, Okeke NL, Bloomfield GS, Corneli A. Specialty Care Referral for Underrepresented Minorities Living with HIV in the United States: Experiences, Barriers, and Facilitators. AIDS Patient Care STDS. 2024 Jun;38(6):259-266. doi: 10.1089/apc.2024.0066. Epub 2024 Jun 13.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00101104
Identifier Type: -
Identifier Source: org_study_id
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