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

March 6, 2026 updated by: Duke University

Pathways to Cardiovascular Disease Prevention and Impact of Specialty Referral in Underrepresented Racial/Ethnic Minorities With HIV (Coordinating Center)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

2039

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27707
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Project is not recruiting patients

  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 and prescription of antiretroviral therapy (ART));

Description

Project is not recruiting as retrospective review of electronic health records.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Visit to a Cardiology Specialist From Cohort
Time Frame: 5 years

A binary variable, with 'yes' defined if there is documented evidence that a ambulatory visit was made with a cardiologist after becoming eligible by CVD risk score, and 'no' otherwise.

Patients were followed from the date when they met eligibility criteria to the date of first encounter with a cardiology specialist or through a maximum of 5 years from their eligibility date. Follow-up was censored early at the end of data collection (December 31, 2020), or 6 months after the patient's last ambulatory visit, if earlier.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of major adverse cardiovascular event, myocardial infarction (secondary outcome for Aim 2)
Time Frame: 5 years
Incidence of first major adverse cardiovascular event (composite of cardiovascular death and myocardial infarction) will be determined from diagnosis and/or procedure codes from electronic health record data and a query of the National Death Index (Plus).
5 years
Incidence of Stroke (secondary outcome for Aim 2)
Time Frame: 5 years
Incidence of first stroke event will be determined from diagnosis and/or procedure codes from electronic health record data.
5 years
Incidence of All-cause death (secondary outcome for Aim 2)
Time Frame: 5 years
Incidence of all-cause death will be determined from electronic health record data and a query of the National Death Index.
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of All-cause Death
Time Frame: 5 years
Incidence of all-cause death will be determined from electronic health record data and a query of the National Death Index.
5 years
Incidence of Stroke
Time Frame: 5 years
Incidence of first stroke event will be determined from diagnosis and/or procedure codes from electronic health record data.
5 years
Incidence of Major Adverse Cardiovascular Event, Myocardial Infarction
Time Frame: 5 years
Incidence of first major adverse cardiovascular event (composite of cardiovascular death and myocardial infarction) will be determined from diagnosis and/or procedure codes from electronic health record data and a query of the National Death Index (Plus).
5 years
Provider Perspective on Facilitators and Barriers to Optimal CVD Prevention
Time Frame: Approximately 60 minutes
Qualitative information will be assessed from semi-structured interviews conducted with participating healthcare providers
Approximately 60 minutes
Patient Perspective on Facilitators and Barriers to Optimal CVD Prevention
Time Frame: Approximately 60 minutes
Qualitative information will be assessed from semi-structured interviews conducted with participating patients
Approximately 60 minutes
Proportion of Patients With Cholesterol Control
Time Frame: Longitudinal evaluation during 5 years of follow up.
Cholesterol control will be defined based on prevailing guidelines during the study period and will be evaluated based on cholesterol laboratory measures recorded in electronic health record data.
Longitudinal evaluation during 5 years of follow up.
Proportion of Patients With Blood Pressure Control
Time Frame: Longitudinal evaluation during 5 years of follow up.
Blood pressure control will be defined based on prevailing guidelines during the study period (blood pressure <140/90 mmHg) and will be evaluated based on blood pressures recorded in electronic health record data.
Longitudinal evaluation during 5 years of follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Gerald Bloomfield, MD, Duke Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00101104
  • 1R01MD013493-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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