Pathways to Cardiovascular Disease Prevention (DCRI Central and Statistical Coordinating Center)

NCT ID: NCT04025125

Last Updated: 2025-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2039 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2020-12-31

Brief Summary

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The goal of this research is to generate evidence-based recommendations for the management of cardiovascular disease (CVD) risk in People Living with HIV (PLWH). The overall objectives of this application are to demonstrate the effect of cardiology referral on CVD outcomes in a racially/ethnically diverse cohort of PLWH, and to generate qualitative data with which to develop of a future intervention. Our central hypothesis is that cardiology referral reduces incident CVD events in underrepresented racial/ethnic minority (URM) populations with HIV compared to nonreferral. Our hypothesis has been formulated based on our own work identifying that race and provider specialty impact cardiovascular risk management. The rationale for our research is that, once it is known how URM populations with HIV access cardiology referrals, and the impact on CVD outcomes, an intervention can be appropriately designed resulting in new and innovative approaches to the management of URM PLWH at elevated CVD risk.

Detailed Description

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To identify factors associated with cardiology referral in under-represented racial and ethnic minority (URM) populations with HIV and elevated cardiovascular risk

Conditions

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HIV/AIDS Cardiovascular Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

Patient health records may be accessed from subjects who meet the following 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

1. Age \<18 years of age or \>99 years of age at index event;
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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 35534889 (View on PubMed)

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.

Reference Type RESULT
PMID: 37160576 (View on PubMed)

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.

Reference Type RESULT
PMID: 40055869 (View on PubMed)

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.

Reference Type RESULT
PMID: 38868933 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R01MD013493-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00101104

Identifier Type: -

Identifier Source: org_study_id

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