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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04025125
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : November 4, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
HIV/AIDS Cardiovascular Diseases

Detailed Description:

Aim 1. To identify factors associated with cardiology referral in under-represented racial and ethnic minority (URM) populations with HIV and elevated cardiovascular risk Aim 2. To evaluate the association between cardiology referral and CVD outcomes in under-represented racial and ethnic populations with HIV and elevated cardiovascular risk Sub-Aim 2a. To evaluate the association between cardiology referral and guideline-based CVD prevention measures in URM populations with HIV and elevated CVD risk

Note: Aims 1 and 2-retrospective analysis with anticipated 8000 EHR records to be reviewed.

Aim 3. To identify facilitators and barriers to optimal CVD prevention

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Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Other
Time Perspective: Other
Official Title: Pathways to Cardiovascular Disease Prevention and Impact of Specialty Referral in Underrepresented Racial/Ethnic Minorities With HIV (Coordinating Center)
Actual Study Start Date : October 29, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Proportion of patients with referral to a cardiology specialist (primary outcome for Aim 1) [ Time Frame: 6 months from the date when patient met eligibility criteria for referral ]
    A binary variable, with 'yes' defined if there is documented evidence that a referral is made within 6 months of becoming eligible by CVD risk score and kept within 3 months of referral, and 'no' otherwise. Cardiology referrals with kept appointments will be ascertained from electronic health record data.

  2. Proportion of patients with blood pressure control (primary outcome for Aim 2) [ 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.

  3. Proportion of patients with Cholesterol control (co-primary outcome for Aim 2) [ 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.

  4. Patient perspective on facilitators and barriers to optimal CVD prevention (co-primary outcome for Aim 3) [ Time Frame: Approximately 60 minutes ]
    Qualitative information will be assessed from semi-structured interviews conducted with participating patients

  5. Provider perspective on facilitators and barriers to optimal CVD prevention (co-primary outcome for Aim 3) [ Time Frame: Approximately 60 minutes ]
    Qualitative information will be assessed from semi-structured interviews conducted with participating healthcare providers


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

Aims 1 and 2 not recruiting patients

Aims 3 population of interest:

  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));
Criteria

Aims 1 and 2 are not recruiting as retrospective review of electronic health records.

Aims 1 and 2 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.

Aims 1 and 2 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.

Aim 3 Inclusion Criteria:

  • Patients:

    1. under-represented racial and ethnic minority (URM) populations with HIV > 40 years of age, with
    2. a modifiable risk factor for Cardiovascular disease (CVD) (such as hypertension, diabetes, elevated total cholesterol, high LDL cholesterol, or currently use tobacco), and/or known CVD
  • Providers

    1. HIV providers will include infectious disease physicians, Internists or advance practice practitioners who report having seen > 1 person living with HIV under their care in the last 6 months; AND
    2. Cardiology providers (physicians or advance practice providers) will be required to have taken care of at least 1 HIV-positive patient in the past 3 years;

Aim 3 Exclusion Criteria:

  • Patients

    1. Unwilling or unable to provide oral informed consent;
    2. Unable to perform an interview in English;
    3. Diminished capacity to give oral consent;
    4. Unwilling to be interviewed.
  • Providers

    1. Unable to perform an interview in English;
    2. Unwilling to be interviewed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025125


Contacts
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Contact: Gretchen Sanders 919-668-7829 gretchen.sanders@duke.edu
Contact: Teresa Swezey 919-668-2742 teresa.swezey@duke.edu

Locations
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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27707
Contact: Sarah Gonzales    919-668-1226    sarah.gonzales@duke.edu   
Principal Investigator: Lance Okeke, MD         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Chris Longenecker, MD         
Principal Investigator: Chris Longenecker, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Samuel Kennedy, MPH    843-876-1490    kennedsa@musc.edu   
Principal Investigator: Eric Meissner, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-2582
Contact: Morgan Lima, BSN    615-936-7448    morgan.c.shearer@vumc.org   
Principal Investigator: April Pettit, MD         
Sponsors and Collaborators
Duke University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Gerald Bloomfield, MD Duke University Health System

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04025125    
Other Study ID Numbers: Pro00101104
1R01MD013493-01 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases