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

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byEleanor M Wilson, MD MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?The VA is the largest single provider of HIV care in the US and Veterans with HIV use significantly more healthcare services and have a 1.5-2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The goal is to improve BP treatment for Veterans with HIV to reduce ASCVD risk. Within a RCT, the investigators hypothesize that the VA adapted nurse-led intervention will result in a clinically significant 6mmHg reduction in SBP over 12 months compared to those receiving enhanced education only. The study is innovative because of the use of stakeholder-engaged design process, multi-component nurse-led intervention, and VA Video Connect (VVC) to monitor CVD risk factors. The project meets VA strategic priorities including: 1) greater choice for Veterans; 2) improve timeliness of services; 3) focus more resources more efficiently (strengthen foundational services in VA). If shown to be effective, this intervention will have substantial impact among high-risk Veterans, potentially reducing ASCVD events by more than a quarter.

Eligibility Criteria

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.

Inclusion Criteria

Hypertension: defined as the average of 4 most recent outpatient BP measurements in the last 18 months to show systolic BP 130 and/or diastolic 90 mmHg (assessed via chart abstraction)

Confirmed HIV+ diagnosis

Undetectable HIV viral load: defined as the most recent HIV viral load < 200 copies/mL, checked within the past 18 months (assessed via chart abstraction)

+3 more

Exclusion Criteria

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

You have a condition that causes memory loss or makes it difficult to think clearly, or you are currently experiencing mental health issues that affect your thoughts and behaviors.

I was hospitalized for heart surgery, heart attack, or stroke in the last 3 months.

+6 more

Participant Groups

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.

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.

Intervention is already approved in United States for the following indications:

🇺🇸 Approved in United States as Digital Meditation Intervention for: