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Nurse-led Cardiovascular Care Coordination for HIV Patients with High Blood Pressure (V-EXTRA-CVD Trial)

N/A

Waitlist Available

Led By Eleanor M Wilson, MD MHS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Age 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

V-EXTRA-CVD Trial Summary

This trial is testing a new nurse-led intervention to improve blood pressure treatment for Veterans with HIV, which could reduce their risk of atherosclerotic cardiovascular disease by more than a quarter.

Who is the study for?

This trial is for Veterans aged 18+ with HIV and high blood pressure, who have internet access and an undetectable viral load. It's not for those with terminal illness, dementia/psychosis, severe hearing/speech impairments, recent major cardiovascular events or those in long-term care facilities.Check my eligibility

What is being tested?

The study tests a nurse-led intervention using VA Video Connect to manage blood pressure and reduce heart disease risk in Veterans with HIV. Participants are randomly assigned to this or an education control group to see if there's a significant difference in blood pressure reduction.See study design

What are the potential side effects?

Since the interventions involve educational measures and remote monitoring rather than medications or invasive procedures, side effects are minimal but may include discomfort due to increased health surveillance.

V-EXTRA-CVD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

V-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

Mean Systolic Blood Pressure

Secondary outcome measures

Non-HDL Cholesterol

V-EXTRA-CVD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.

Group II: Education control groupActive Control1 Intervention

Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intervention group

2016

N/A

~4530

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,298 Total Patients Enrolled

Eleanor M Wilson, MD MHSPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Hayden B Bosworth, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC

5 Previous Clinical Trials

1,072 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals are enrolled in the current clinical trial?

"This medical research necessitates 350 appropriate candidates to partake in the study. Potential volunteers can apply from Atlanta VA Medical and Rehab Center, Decatur, GA or Durham VA Medical Center, Durham NC."

Answered by AI

To what extent have hospitals embraced this experiment?

"This clinical trial is currently running in 4 locations, including Decatur, Durham and Baltimore. To minimize travel requirements if you wish to join the study, it's beneficial to pick a location nearby."

Answered by AI

Are there any available slots in this clinical investigation for participants?

"Indeed, clinicaltrials.gov affirms that this medical trial has been recruiting since its December 1st 2020 posting and is still actively enrolling patients today. 350 people are needed to be enlisted from 4 distinct medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention

2020. "A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04545489.

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