| Condition or disease |
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| HIV/AIDS Cardiovascular Diseases |
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
| 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 |
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Aims 1 and 2 not recruiting patients
Aims 3 population of interest:
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:
Aims 1 and 2 Exclusion criteria:
Aim 3 Inclusion Criteria:
Patients:
Providers
Aim 3 Exclusion Criteria:
Patients
Providers
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27707 | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| University Hospitals Cleveland Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232-2582 | |
| Principal Investigator: | Gerald Bloomfield, MD | Duke Health |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 2, 2019 | ||||
| First Posted Date | July 18, 2019 | ||||
| Last Update Posted Date | August 5, 2020 | ||||
| Actual Study Start Date | October 29, 2019 | ||||
| Estimated Primary Completion Date | October 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 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) | ||||
| 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 |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Other |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population |
Aims 1 and 2 not recruiting patients Aims 3 population of interest:
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| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Estimated Enrollment |
62 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | October 1, 2021 | ||||
| Estimated Primary Completion Date | October 1, 2021 (Final data collection date for primary outcome measure) | ||||
| 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:
Aims 1 and 2 Exclusion criteria:
Aim 3 Inclusion Criteria:
Aim 3 Exclusion Criteria:
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| Sex/Gender |
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| Ages | 40 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04025125 | ||||
| Other Study ID Numbers | Pro00101104 1R01MD013493-01 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Duke University | ||||
| Study Sponsor | Duke University | ||||
| Collaborators | National Institute on Minority Health and Health Disparities (NIMHD) | ||||
| Investigators |
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| PRS Account | Duke University | ||||
| Verification Date | August 2020 | ||||