Clinical trial NCT04025125: Pathways to Cardiovascular Disease Prevention (DCRI Central and Statistical Coordinating Center)
Official title: Pathways to Cardiovascular Disease Prevention and Impact of Specialty Referral in Underrepresented Racial/Ethnic Minorities With HIV (Coordinating Center)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Cardiovascular Diseases
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-07-18
Enrollment: 57
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
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));

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.

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

Eligibility 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.

Primary outcomes:
measure: Proportion of patients with referral to a cardiology specialist (primary outcome for Aim 1)
timeFrame: 6 months from the date when patient met eligibility criteria for referral
measure: Proportion of patients with blood pressure control (primary outcome for Aim 2)
timeFrame: Longitudinal evaluation during 5 years of follow up.
measure: Proportion of patients with Cholesterol control (co-primary outcome for Aim 2)
timeFrame: Longitudinal evaluation during 5 years of follow up.
measure: Patient perspective on facilitators and barriers to optimal CVD prevention (co-primary outcome for Aim 3)
timeFrame: Approximately 60 minutes
measure: Provider perspective on facilitators and barriers to optimal CVD prevention (co-primary outcome for Aim 3)
timeFrame: Approximately 60 minutes
Secondary outcomes:
measure: Incidence of major adverse cardiovascular event, myocardial infarction (secondary outcome for Aim 2)
timeFrame: 5 years
measure: Incidence of Stroke (secondary outcome for Aim 2)
timeFrame: 5 years
measure: Incidence of All-cause death (secondary outcome for Aim 2)
timeFrame: 5 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Duke Health
name: Gerald Bloomfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.