A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention (EXTRA-CVD)
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ClinicalTrials.gov Identifier: NCT03643705 |
Recruitment Status :
Recruiting
First Posted : August 23, 2018
Last Update Posted : October 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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HIV/AIDS Hypertension Hyperlipidemias | Other: Multi-component intervention Other: General prevention education | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention |
Actual Study Start Date : | September 20, 2019 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | June 2022 |

Arm | Intervention/treatment |
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Experimental: Nurse Intervention
This multi-component intervention will consist of four evidence-based components delivered at 4 in-person visits (0, 4, 8, and 12 months) and by telephone contact: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home blood pressure monitoring, and (4) electronic medical records support tools.
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Other: Multi-component intervention
4 components as described |
Active Comparator: Education Control
Participants in the education control arm will receive general prevention education delivered at 4 in-person visits (0, 4, 8, and 12 months), which will consist of evidence-based material on diet, exercise, smoking, sexually transmitted infections, and cancer prevention.
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Other: General prevention education
General education as described |
- Systolic blood pressure [ Time Frame: 12 months ]Repeated measures across 4 time points (0, 4, 8, and 12 months)
- Non high density lipoprotein (Non-HDL) cholesterol [ Time Frame: 12 months ]Repeated measures across 4 time points (0, 4, 8, and 12 months)
- % of subjects in each hypertension cascade category [ Time Frame: 12 months ]Ordinal 4-level variable across 4 time points (0, 4, 8, and 12 months). The hypertension cascade tool consists of mutually exclusive categories as follows: 1=undiagnosed hypertension; 2=hypertension diagnosed; 3=hypertension diagnosed and appropriately managed; 4=hypertension diagnosed, appropriately managed, and blood pressure target achieved.
- % of subjects in each hyperlipidemia cascade category [ Time Frame: 12 months ]Ordinal 4-level variable across 4 time points (0, 4, 8, and 12 months). The hypercholesterolemia cascade tool consists of ordered categories as follows: 1=undiagnosed hyperlipidemia; 2=hyperlipidemia diagnosed; 3=hyperlipidemia diagnosed and appropriately managed; 4=hyperlipidemia diagnosed, appropriately managed, and non-HDL cholesterol target achieved.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥18 years
- Laboratory confirmed HIV+ diagnosis
- Undetectable HIV viral load: defined as the most recent HIV viral load <200 copies/mL, checked within the past year (assessed via chart abstraction)
- Hypertension: defined as systolic blood pressure >140 mmHg on ≥ 2 occasions in the past 12 months or on an antihypertensive medication (assessed via chart abstraction)
- Hyperlipidemia: defined as a non-high-density lipoprotein cholesterol level that is greater than the National Lipid Association target [130mg/dl for moderate to high risk (≥ 2 major risk factors) or 100mg/dl for very high risk (known ASCVD or diabetes + ≥2 major risk factors)]. Major risk factors include HIV, Age >45 men or >55 women, family history of early coronary artery disease, smoking, hypertension, low high-density lipoprotein cholesterol. By design, all participants in our study will be ≥ moderate risk.
Exclusion Criteria:
- On lipid-lowering medication solely for cardiovascular disease prevention with evidence of pre-medication non-high-density lipoprotein cholesterol which was already below National Lipid Association target
- On anti-hypertensive medications solely for a non-hypertension indication (e.g. systolic heart failure)
- Severely hearing or speech impaired, or other disability that would limit participation in the intervention components
- In a nursing home and/or receiving in-patient psychiatric care
- Terminal illness with life expectancy < 4 months
- No reliable access to a telephone
- Pregnant, breast-feeding, or planning a pregnancy during the study period
- Planning to move out of the area in the next 12 months

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): NCT03643705
Contact: Chris T Longenecker, MD | 216-368-0728 | cxl473@case.edu | |
Contact: Allison R Webel, RN PhD | 216-368-3939 |
United States, North Carolina | |
Duke Health | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Kiran Grover kiran.grover@duke.edu | |
United States, Ohio | |
University Hospitals Cleveland Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Molly Steidl 216-844-7188 Molly.Steidl@uhhospitals.org | |
MetroHealth Medical Center | Recruiting |
Cleveland, Ohio, United States, 44109 | |
Contact: Margaret Oblak 216-778-5489 moblak@metrohealth.org |
Principal Investigator: | Chris T Longenecker, MD | Case Western Reserve University | |
Principal Investigator: | Allison R Webel, RN PhD | Case Western Reserve University | |
Principal Investigator: | Hayden Bosworth, PhD | Duke University |
Responsible Party: | Chris Todd Longenecker, Assistant Professor of Medicine, Case Western Reserve University |
ClinicalTrials.gov Identifier: | NCT03643705 |
Other Study ID Numbers: |
03-18-16 U01HL142099 ( U.S. NIH Grant/Contract ) |
First Posted: | August 23, 2018 Key Record Dates |
Last Update Posted: | October 22, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | In collaboration with the National Institutes of Health funding body, we will develop a process to facilitate providing other investigators with access to appropriately de-identified study data. We will make the following available upon request after the primary manuscript is published: de-identified data set, trial description information, data collection forms, and data structure. |
Time Frame: | After publication of the primary manuscript |
Access Criteria: | Data will be made available upon request or on a data share site after publication of the primary manuscript. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Implementation Science Cardiovascular Disease Prevention |
Cardiovascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |