Nurse-led Cardiovascular Care Coordination for HIV Patients with High Blood Pressure

(V-EXTRA-CVD Trial)

Recruiting at 3 trial locations

Overseen By Hayden B Bosworth, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Psychosis, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

305 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Hayden B Bosworth, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Puja Van Epps, MD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

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)

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a nurse-led intervention involving care coordination, medication management, home BP monitoring, and VA Video Connect (VVC) for 12 months

12 months

4 visits (in-person or virtual) over 12 months

Education Control

Participants receive enhanced education and usual care related to CVD risk reduction for 12 months

12 months

4 visits (in-person or virtual) over 12 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Education
• Intervention
• Nurse-led Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 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 group Active Control 1 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:

• Loneliness in Older Adults
• Social Isolation
• Emotional Well-being

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+