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

(V-EXTRA-CVD Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a nurse-led approach to assist Veterans with HIV who also have high blood pressure. The goal is to determine if close collaboration with nurses in managing blood pressure can reduce the risk of heart disease. Participants will either receive personalized support from a nurse (Nurse-led Intervention) or only educational materials. Veterans with well-managed HIV and high blood pressure may qualify for this trial. Regular internet access is required for participation.

As an unphased trial, this study provides Veterans the chance to contribute to innovative care strategies that could enhance health outcomes for others with similar conditions.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this nurse-led intervention is safe for HIV patients with high blood pressure?

Research has shown that nurse-led care is generally safe and effective for managing blood pressure and heart health in people with HIV. In past studies, individuals who received care from nurses achieved better blood pressure control without major safety issues. These care plans often include regular check-ins and personalized support to manage side effects.

While the details of the current trial are not covered here, existing evidence suggests that similar nurse-led approaches have been effective and safe in other contexts. Participants in previous studies reported positive outcomes with no major side effects. This indicates that the approach used in this trial should also be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a nurse-led approach to managing high blood pressure in HIV patients, which is not typical in standard care. Unlike traditional methods that often rely solely on medication, this approach includes personalized visits and communication with healthcare professionals like nurses or pharmacists. This method aims to enhance blood pressure monitoring and medication management, potentially leading to better cardiovascular outcomes. By focusing on tailored care and consistent follow-up, this strategy could offer a more holistic and effective way to manage cardiovascular risks in this unique patient population.

What evidence suggests that this nurse-led intervention is effective for reducing high blood pressure in HIV patients?

Research shows that nurses play a key role in helping people with HIV manage heart health risks. In this trial, participants in the intervention group will receive nurse-led care, including focused communication, regular check-ups, and medication management to control blood pressure. Studies have found that nurse-led care efforts can reduce heart problems by better controlling blood pressure. For example, one study found that a nurse-led approach improved blood pressure control in people with HIV. Overall, nurse-led care shows promise in reducing heart health risks for people with HIV. ^{6 7 8 9 10}

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

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+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815688

Nurse-Led Strategy to Improve Blood Pressure and ... Findings of this trial suggest that nurse-led cardiovascular risk factor management in academic HIV clinics may lead to fewer cardiovascular events.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10915684/

Nurse-Led Strategy to Improve Blood Pressure and ... This randomized clinical trial assesses the effectiveness of a cardiovascular risk factor management intervention supported by a dedicated nurse.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03643705

A Nurse-led Intervention to Extend the HIV Treatment ... This study tests an innovative prevention nurse intervention to extend the HIV/AIDS treatment cascade for the treatment of hypertension and hyperlipidemia among ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/25787489.2025.2477396

Virtual adaptation of a nurse-driven strategy to improve ... Our study effectively improved hypertension control in people with HIV through a virtual, nurse-led intervention.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31419622/

Rationale and design of a nurse-led intervention to extend the ... The primary outcome will be change in systolic blood pressure and secondary outcome will be change in non-HDL cholesterol over the course of the intervention.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/14/NCT03945214/Prot_SAP_000.pdf

Title: The Impact of 8 Weeks of Digital Meditation Application and ... The aim of the present study is to test the effects of a digital meditation intervention in a sample of high stress UCSF employees.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6107378/

Meditation Smartphone Application Effects on Pre ... Smartphone-implemented BAM appears to reduce SBP and can be a low cost method to reach large populations.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00600561

Mindfulness Meditation Training in HIV (MBSR) Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

9. mhealth.jmir.org mhealth.jmir.org/2015/3/e82/citations

Review and Evaluation of Mindfulness-Based iPhone Apps ... Meditation and Eating Apps among People with High Blood Pressure. ... Training: Feasibility and Preliminary Outcomes of a Digital Course for High ...

10. mdpi.com mdpi.com/1660-4601/17/6/1955

Impact of 12-Month Smartphone Breathing Meditation ... The TT app was beneficial in reducing SBP levels among adults with stage 1 systolic HTN. The TT app may be a promising, scalable first-line tactic for stage 1 ...