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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

Must not have

Terminal illness with life expectancy < 4 months (ex. Metastatic cancer, Hospice care)

In a nursing home at baseline and/or any long-term care facility. Individuals will be censored at the point of entering nursing home care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My doctor expects I have less than 4 months to live due to my illness.

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I am not living in a nursing home or long-term care facility at the start.

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I have a severe hearing, speech impairment, or other disability that limits my participation.

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I have been hospitalized for psychiatric care.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Systolic Blood Pressure

Secondary study objectives

Non-HDL Cholesterol

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met