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Completed

NCT Number: NCT04025125

Pathways to Cardiovascular Disease Prevention (DCRI Central and Statistical 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.

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Key information

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:

  • 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;
  • Documented evidence of HIV positive status (HIV positive diagnosis (ICD10 codes B20-B24, or ICD9 codes 042, V08) and prescription of antiretroviral therapy (ART));
  • 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
  • Presence of a modifiable risk factor: hypertension, diabetes, elevated total cholesterol, elevated LDL cholesterol and/or tobacco use.

Exclusion criteria

  • Age <18 years of age or >99 years of age at index event;
  • 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;
  • Encounter with cardiology specialist within 1 year prior to index
  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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

  5. 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

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2019
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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