A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention (EXTRA-CVD)

• ClinicalTrials.gov Identifier: NCT03643705
• Recruitment Status: Recruiting
• First Posted: August 23, 2018
• Last Update Posted: October 14, 2019
• Sponsor: Case Western Reserve University
• Collaborators: Duke University; University Hospitals Cleveland Medical Center; MetroHealth Medical Center; National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Chris Todd Longenecker, Case Western Reserve University

Study Description

Brief Summary:

Strategies to improve uptake of cardiovascular disease preventive therapies among people living with HIV (PLHIV) are urgently needed. This study tests an innovative prevention nurse intervention to extend the HIV/AIDS treatment cascade for the treatment of hypertension and hyperlipidemia among PLHIV on suppressive antiretroviral therapy. This intervention may be scalable as an extension of ongoing HIV/AIDS treatment cascade initiatives in HIV specialty clinics nationwide.

Condition or disease	Intervention/treatment	Phase
HIV/AIDS; Hypertension; Hyperlipidemias	Other: Multi-component intervention; Other: General prevention education	Not Applicable

Detailed Description:

People living with HIV (PLHIV) are at increased risk for atherosclerotic cardiovascular disease (ASCVD); however, uptake of evidence based therapies to prevent ASCVD is sub-optimal. Reasons for under treatment may include low perceived risk, competing priorities for HIV specialist providers, and poor trust and communication with non-HIV primary care providers. This project proposes a nurse-led intervention to extend the HIV/AIDS treatment cascade—a widely adopted framework developed to improve access to high quality HIV care—for CVD prevention, specifically to improve control of blood pressure and hyperlipidemia in PLHIV on antiretroviral therapy who have suppressed HIV viral load. The study will be conducted in three racially and ethnically diverse clinic contexts [University Hospitals (Cleveland, OH), MetroHealth (Cleveland, OH) and Duke Health (Durham, NC)] that are broadly representative of HIV specialty care in the US. Using a mixed-methods clinical effectiveness trial design, this project will test the 12-month efficacy of a multi-component intervention among n=300 HIV+ adults on suppressive ART with hypertension and hyperlipidemia. Participants will be randomized 1:1 to intervention vs. education control. Control participants will receive general prevention education. The intervention will consist of four evidence-based components derived from prior studies in the general population: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic medical records (EMR) support tools. These components will be further adapted to the HIV specialty clinic context with key stakeholder input and using data from a mixed-methods study of current ASCVD preventive care practices at the three HIV clinic sites. A process evaluation of the prevention nurse intervention will be conducted, which will assess fidelity, dose, recruitment, reach, and context. Two key contextual process measures of interest will be changes in perceived ASCVD risk and changes in trust and communication between PLHIV participants and their HIV and non-HIV providers. If proven effective to reduce both blood pressure and cholesterol as postulated, this nurse-led intervention will have substantial clinical impact among high-risk PLHIV, potentially reducing ASCVD events by more than a quarter. This model is potentially scalable as an extension of HIV treatment cascade initiatives nationwide.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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.	Other: General prevention education; General education as described

Outcome Measures

Primary Outcome Measures :

1. Systolic blood pressure [ Time Frame: 12 months ]
   Repeated measures across 4 time points (0, 4, 8, and 12 months)

Secondary Outcome Measures :

1. Non high density lipoprotein (Non-HDL) cholesterol [ Time Frame: 12 months ]
   Repeated measures across 4 time points (0, 4, 8, and 12 months)

Other Outcome Measures:

1. % 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.
2. % 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age ≥18 years
2. Laboratory confirmed HIV+ diagnosis
3. Undetectable HIV viral load: defined as the most recent HIV viral load <200 copies/mL, checked within the past year (assessed via chart abstraction)
4. 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)
5. 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:

1. 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
2. On anti-hypertensive medications solely for a non-hypertension indication (e.g. systolic heart failure)
3. Severely hearing or speech impaired, or other disability that would limit participation in the intervention components
4. In a nursing home and/or receiving in-patient psychiatric care
5. Terminal illness with life expectancy < 4 months
6. No reliable access to a telephone
7. Pregnant, breast-feeding, or planning a pregnancy during the study period
8. Planning to move out of the area in the next 12 months

Contacts and Locations

Contacts

Contact: Chris T Longenecker, MD; 216-368-0728; cxl473@case.edu

Contact: Allison R Webel, RN PhD; 216-368-3939

Locations

United States, North Carolina

Duke Health; Not yet 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

MetroHealth Medical Center; Recruiting

Cleveland, Ohio, United States, 44109

Contact: Margaret Oblak 216-778-5489 moblak@metrohealth.org

Sponsors and Collaborators

Case Western Reserve University

Duke University

University Hospitals Cleveland Medical Center

MetroHealth Medical Center

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• 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

More Information

• 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
• Last Update Posted: October 14, 2019
• Last Verified: October 2019

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

Keywords provided by Chris Todd Longenecker, Case Western Reserve University:

Implementation Science; Cardiovascular Disease; Prevention

Additional relevant MeSH terms:

Hyperlipidemias; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases