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Multi-component intervention for High Blood Pressure (EXTRA-CVD Trial)

N/A

Waitlist Available

Led By Barb Gripshover, MD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

EXTRA-CVD Trial Summary

This trial tests a new prevention nurse intervention to improve uptake of cardiovascular disease preventive therapies among people living with HIV. The intervention may be scalable as an extension of ongoing HIV/AIDS treatment cascade initiatives in HIV specialty clinics nationwide.

Eligible Conditions

High Blood Pressure
High Cholesterol
HIV/AIDS

EXTRA-CVD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Systolic blood pressure

Secondary outcome measures

Non high density lipoprotein (Non-HDL) cholesterol

Other outcome measures

% of subjects in each hyperlipidemia cascade category

% of subjects in each hypertension cascade category

EXTRA-CVD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nurse InterventionExperimental Treatment1 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.

Group II: Education ControlActive Control1 Intervention

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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Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor

299 Previous Clinical Trials

259,722 Total Patients Enrolled

Duke UniversityOTHER

2,358 Previous Clinical Trials

3,419,771 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,834 Previous Clinical Trials

47,310,337 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment still taking place?

"Per clinicaltrials.gov, this particular trial is not accepting new candidates. The study was initially announced on September 20th 2019 and last updated on January 5th 2022. Despite the unavailability of enrollment into this specific investigation, there are 1,237 additional trials recruiting patients at present."

Answered by AI

Recent research and studies

Implementation Science CommunicationsJournal

Understanding Constraints on Integrated Care for People with HIV and Multimorbid Cardiovascular Conditions: An Application of the Theoretical Domains Framework

Schexnayder, Julie, Chris T. Longenecker, Charles Muiruri, Hayden B. Bosworth, Daniel Gebhardt, Sarah E. Gonzales, Jan E. Hanson, et al.. 2021. “Understanding Constraints on Integrated Care for People with HIV and Multimorbid Cardiovascular Conditions: An Application of the Theoretical Domains Framework”. Implementation Science Communications. Springer Science and Business Media LLC. doi:10.1186/s43058-021-00114-z.

American Heart JournalJournal

Rationale and Design of a Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention Trial (EXTRA-CVD)

Okeke, Nwora Lance, Allison R. Webel, Hayden B. Bosworth, Angela Aifah, Gerald S. Bloomfield, Emily W. Choi, Sarah Gonzales, et al.. 2019. “Rationale and Design of a Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention Trial (EXTRA-CVD)”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2019.07.005.

BMC Public HealthJournal

The Influence of Healthcare Financing on Cardiovascular Disease Prevention in People Living with HIV

Webel, Allison R., Julie Schexnayder, C. Robin Rentrope, Hayden B. Bosworth, Corrilynn O. Hileman, Nwora Lance Okeke, Rajesh Vedanthan, and Chris T. Longenecker. 2020. “The Influence of Healthcare Financing on Cardiovascular Disease Prevention in People Living with HIV”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-020-09896-8.

American Heart JournalJournal