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

NCT04545489 | Completed Results DMC

• 1 other identifier: IIR 19-418
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cardiovascular Disease; Hypertension; Care Coordination; HIV Treatment Cascade

Keywords

HIV; Cardiovascular Disease; Medication Management; Care Coordination

Outcome Measures

Primary Outcomes (4)

• Mean Systolic Blood Pressure

  Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.

  Baseline

• Mean Systolic Blood Pressure

  Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.

  4 months

• Mean Systolic Blood Pressure

  Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.

  8 months

• Mean Systolic Blood Pressure

  Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.

  12 months

Secondary Outcomes (4)

• Non-HDL Cholesterol

  Baseline

• Non-HDL Cholesterol

  4 months

• Non-HDL Cholesterol

  8 months

• Non-HDL Cholesterol

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Intervention group

Education control group

ACTIVE COMPARATOR

Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.

Behavioral: Education control group

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)

Intervention group

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.

Education control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

Related Publications (2)

• Schexnayder J, Perry KR, Sheahan K, Majette Elliott N, Subramaniam S, Strawbridge E, Webel AR, Bosworth HB, Gierisch JM. Team-Based Qualitative Rapid Analysis: Approach and Considerations for Conducting Developmental Formative Evaluation for Intervention Design. Qual Health Res. 2023 Jul;33(8-9):778-789. doi: 10.1177/10497323231167348. Epub 2023 Jun 6.

  PMID: 37278662 RESULT

• Musoke L, Bosworth HB, Dickson C, Gentry P, Strawbridge E, Subramaniam S, Gierisch J, Smith V, Woolson S, Pura J, Amutuhaire W, Naggie S, Schexnayder J, Hall K, Longenecker CT, Harris NM, Rogers C, Van Epps P; for V-EXTRA-CVD Group. A telehealth-delivered intervention to extend the veteran HIV treatment cascade for cardiovascular disease prevention: V-EXTRA-CVD study protocol for a randomized controlled trial. HIV Res Clin Pract. 2023 Dec;24(1):2261747. Epub 2023 Oct 6.

  PMID: 37800987 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Limitations and Caveats

Recruitment challenges led to adjustments in inclusion criteria prior to study start, which affected baseline systolic blood pressure levels. The study was designed to evaluate systolic blood pressure (SBP) outcomes, not exploratory subgroup analyses. The generalizability is limited to VA-based HIV populations.

Results Point of Contact

• Title: Dr. Hayden Bosworth, PhD
• Organization: Durham VA Health Care System

Hayden.Bosworth@va.gov

919-286-0411

Study Officials

• Hayden B Bosworth, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

• Puja Van Epps, MD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 11, 2020
• Study Start: December 1, 2020
• Primary Completion: October 1, 2024
• Study Completion: March 31, 2025
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 1 year of the final follow-up with the last study participant.
• Access Criteria: Guidance on request and distribution processes will be provided by the VA Office of Research and Development (ORD).

Locations

US (4)