A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT04545489
Status
Completed

Conditions

  • Cardiovascular Disease
  • Care Coordination
  • HIV Treatment Cascade
  • Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intervention group — BEHAVIORAL
    This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
  • Education control group — BEHAVIORAL
    This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.

Study Details

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.

Key Dates

Start date
Dec 1, 2020
Status verified
Oct 2025
Primary completion
Oct 1, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
305 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention group
    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.
  • Active Comparator: Education control group
    Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.

Primary Outcome Measure

Mean Systolic Blood Pressure [ Time Frame: Baseline ]

Locations (4)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004-
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimoreMaryland21201-
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875-
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702-

Find similar trials in Decatur, GA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Atlanta VA Medical and Rehab Center, Decatur, GA· Decatur, GABaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD· Baltimore, MDDurham VA Medical Center, Durham, NC· Durham, NCLouis Stokes VA Medical Center, Cleveland, OH· Cleveland, OH

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