N/A
N=301
A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention
Cardiovascular Disease · Hypertension · Care Coordination · HIV Treatment Cascade
Bottom Line
View on ClinicalTrials.gov: NCT04545489 ↗Enrolled (actual)
301
Serious AEs
11.3%
Results posted
Oct 2025
Primary outcome: Primary: Mean Systolic Blood Pressure — 134.6; 133.3 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention group (Behavioral); Education control group (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Systolic Blood Pressure |
130.5; 130.6 | — |
| PRIMARY Mean Systolic Blood Pressure |
130.5; 130.6 | — |
| PRIMARY Mean Systolic Blood Pressure |
130.5; 130.6 | — |
| PRIMARY Mean Systolic Blood Pressure |
130.5; 130.6 | — |
| SECONDARY Non-HDL Cholesterol |
110.8; 115.2 | — |
| SECONDARY Non-HDL Cholesterol |
110.8; 115.2 | — |
| SECONDARY Non-HDL Cholesterol |
110.8; 115.2 | — |
| SECONDARY Non-HDL Cholesterol |
110.8; 115.2 | — |
Summary
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 randomized controlled trial (RCT), the investigators hypothesize that the VA adapted nurse-led intervention will result in a clinically significant 6 millimeters of mercury (mmHg) reduction in systolic blood pressure (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
Inclusion Criteria
- Age => 18 years
- 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)
- 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)
- Veteran at one of the sites participating in the study
- Regular access to a computer, tablet or smart phone device with internet.
Exclusion Criteria
- Severely hearing or speech impaired, or other disability that would limit participation
- 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
- In-patient psychiatric care
- Diagnosis of dementia or active psychosis
- Terminal illness with life expectancy < 4 months (ex. Metastatic cancer, Hospice care)
- Recent (<90day) hospitalization for coronary artery bypass surgery (CABG), myocardial infarction (MI), stroke)
- Pregnant, breast-feeding, or planning a pregnancy during the study period
- Planning to move out of the area in the next 12 months.
- No reliable access to telephone services
Data sourced from ClinicalTrials.gov (NCT04545489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.