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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD013493-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
To identify factors associated with cardiology referral in under-represented racial and ethnic minority (URM) populations with HIV and elevated cardiovascular risk
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All-cause Death | 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 | Incidence of first stroke event will be determined from diagnosis and/or procedure codes from electronic health record data. |
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:
Exclusion criteria:
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Project is not recruiting patients
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Bloomfield, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27707 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35534889 | Background | 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. | |
| 37160576 | Result | 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. |
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As is pre-specified in the study protocol, Aim 3 data are not reported here.
retrospective data study
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall | cohort who have new elevated Cardiovascular Disease (CVD) risk |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Overall cohort. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 5 years |
|
5 years
This record is specific to Aim 1 only. Only all-cause mortality was collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall | cohort who have new elevated CVD risk | 137 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerald Bloomfield | Duke University | 919-668-8702 | gerald.bloomfield@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2024 | Jan 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 5 years |
| Incidence of Major Adverse Cardiovascular Event, Myocardial Infarction | 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 | 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 | Qualitative information will be assessed from semi-structured interviews conducted with participating patients | Approximately 60 minutes |
| Proportion of Patients With Cholesterol Control | 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 | 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. |
| 40055869 | 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. |
| 38868933 | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score | The ASCVD risk score is calculated using a formula developed by the American College of Cardiology (ACC) and the American Heart Association (AHA). The formula takes into account the individual's risk factors and outputs a 10-year risk percentage. The ASCVD risk score is categorized as follows: Low risk: < 5%, Borderline risk: 5-7.4%, Intermediate risk: 7.5-19.9%, High risk: ≥ 20%. | 1001 participants had data or were eligible for ASCVD analysis scoring. | Median | Inter-Quartile Range | 10-year risk percentage |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Other Pre-specified | Incidence of All-cause Death | Incidence of all-cause death will be determined from electronic health record data and a query of the National Death Index. | Not Posted | 5 years | Participants |
| Other Pre-specified | Incidence of Stroke | Incidence of first stroke event will be determined from diagnosis and/or procedure codes from electronic health record data. | Not Posted | 5 years | Participants |
| Other Pre-specified | Incidence of Major Adverse Cardiovascular Event, Myocardial Infarction | 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). | Not Posted | 5 years | Participants |
| Other Pre-specified | Provider Perspective on Facilitators and Barriers to Optimal CVD Prevention | Qualitative information will be assessed from semi-structured interviews conducted with participating healthcare providers | Not Posted | Approximately 60 minutes | Participants |
| Other Pre-specified | Patient Perspective on Facilitators and Barriers to Optimal CVD Prevention | Qualitative information will be assessed from semi-structured interviews conducted with participating patients | Not Posted | Approximately 60 minutes | Participants |
| Other Pre-specified | Proportion of Patients With Cholesterol Control | 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. | Not Posted | Longitudinal evaluation during 5 years of follow up. | Participants |
| Other Pre-specified | Proportion of Patients With Blood Pressure Control | 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. | Not Posted | Longitudinal evaluation during 5 years of follow up. | Participants |
| 2,039 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |