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

NCT04025125 | Completed Results

• 2 other identifiers: Pro001011041R01MD013493-01
• Study Type: observational
• Target: 2,039
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Visit to a Cardiology Specialist From Cohort

  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

Other Outcomes (7)

• Incidence of All-cause Death

  5 years

• Incidence of Stroke

  5 years

• Incidence of Major Adverse Cardiovascular Event, Myocardial Infarction

  5 years

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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));

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27707, United States

Location

Related Publications (4)

• 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.

  PMID: 35534889 BACKGROUND

• 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.

  PMID: 37160576 RESULT

• 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.

  PMID: 40055869 RESULT

• 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.

  PMID: 38868933 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Gerald Bloomfield
• Organization: Duke University

gerald.bloomfield@duke.edu

919-668-8702

Study Officials

• Gerald Bloomfield, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 18, 2019
• Study Start: January 1, 2014
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 9, 2026
• Results First Posted: August 1, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)