A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
EXTRA-CVD
2 other identifiers
interventional
298
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2018
CompletedFirst Posted
Study publicly available on registry
August 23, 2018
CompletedStudy Start
First participant enrolled
September 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2023
CompletedResults Posted
Study results publicly available
April 23, 2024
CompletedOctober 16, 2024
September 1, 2024
3.3 years
August 20, 2018
March 27, 2024
September 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systolic Blood Pressure
Repeated measures across 4 time points (0, 4, 8, and 12 months)
12 months
Secondary Outcomes (1)
Non High Density Lipoprotein (Non-HDL) Cholesterol
12 months
Other Outcomes (2)
% of Subjects in Each Hypertension Cascade Category
12 months
% of Subjects in Each Hyperlipidemia Cascade Category
12 months
Study Arms (2)
Nurse Intervention
EXPERIMENTALThis 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.
Education Control
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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 \>130 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 \>130mg/dL or on cholesterol lowering medication
You may not qualify if:
- On lipid-lowering medication solely for cardiovascular disease prevention with evidence of pre-medication non-high-density lipoprotein cholesterol which was already below 100mg/dL
- 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
- Non-English Speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Western Reserve Universitylead
- Duke Universitycollaborator
- University Hospitals Cleveland Medical Centercollaborator
- MetroHealth Medical Centercollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Washingtoncollaborator
Study Sites (3)
Duke Health
Durham, North Carolina, 27710, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Related Publications (4)
Longenecker CT, Jones KA, Hileman CO, Okeke NL, Gripshover BM, Aifah A, Bloomfield GS, Muiruri C, Smith VA, Vedanthan R, Webel AR, Bosworth HB. Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e2356445. doi: 10.1001/jamanetworkopen.2023.56445.
PMID: 38441897DERIVEDSchexnayder J, Longenecker CT, Muiruri C, Bosworth HB, Gebhardt D, Gonzales SE, Hanson JE, Hileman CO, Okeke NL, Sico IP, Vedanthan R, Webel AR. Understanding constraints on integrated care for people with HIV and multimorbid cardiovascular conditions: an application of the Theoretical Domains Framework. Implement Sci Commun. 2021 Feb 12;2(1):17. doi: 10.1186/s43058-021-00114-z.
PMID: 33579396DERIVEDWebel AR, Schexnayder J, Rentrope CR, Bosworth HB, Hileman CO, Okeke NL, Vedanthan R, Longenecker CT. The influence of healthcare financing on cardiovascular disease prevention in people living with HIV. BMC Public Health. 2020 Nov 23;20(1):1768. doi: 10.1186/s12889-020-09896-8.
PMID: 33228623DERIVEDOkeke NL, Webel AR, Bosworth HB, Aifah A, Bloomfield GS, Choi EW, Gonzales S, Hale S, Hileman CO, Lopez-Kidwell V, Muiruri C, Oakes M, Schexnayder J, Smith V, Vedanthan R, Longenecker CT. Rationale and design of a nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention trial (EXTRA-CVD). Am Heart J. 2019 Oct;216:91-101. doi: 10.1016/j.ahj.2019.07.005. Epub 2019 Jul 18.
PMID: 31419622DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Chris Longenecker
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Chris T Longenecker, MD
University of Washington
- PRINCIPAL INVESTIGATOR
Allison R Webel, RN PhD
University of Washington
- PRINCIPAL INVESTIGATOR
Hayden Bosworth, PhD
Duke University
- PRINCIPAL INVESTIGATOR
Barb Gripshover, MD
Case Western Reserve University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
August 20, 2018
First Posted
August 23, 2018
Study Start
September 20, 2019
Primary Completion
January 15, 2023
Study Completion
January 15, 2023
Last Updated
October 16, 2024
Results First Posted
April 23, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- 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.
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.