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CompletedNCT04545489V-EXTRA-CVDUpdated Oct 30, 2025Results posted

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

An interventional study of Intervention group and Education control group in Cardiovascular Disease, Hypertension and Care Coordination, sponsored by VA Office of Research and Development. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-30.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
305
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Background: The VA is the largest provider of HIV care in the United States. The \~31,000 Veterans with HIV use significantly more healthcare and have up to 2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The HIV treatment cascade model includes care steps; once people obtain remission, providers should focus on preventing ASCVD. The investigators will extend the HIV treatment cascade and focus on reducing ASCVD risk among people with HIV. Veterans with HIV have low perceived risk for ASCVD and uptake of guideline-based treatment for BP is low.

Significance/Impact: The proposed intervention has the potential to reduce ASCVD events in this population by more than a quarter and meet VA strategic priorities of: 1) improve timeliness of services; 2) focus resources more efficiently as well as address health systems research (HSR) research priorities: 1) patient centered care, care management, and health promotion; 2) healthcare access; 3) aging; 4) virtual care.

Innovation: The study is innovative: Cascade Model. By leveraging the HIV treatment cascade model, the investigators will create a pathway for ASCVD risk reduction to be added into widespread quality improvement initiatives. Stakeholder-engaged design process. The investigators will employ stakeholder-engaged research methods to ensure the intervention meets the needs of patients and healthcare providers. Multi-component nurse-led intervention. While each of the components of the intervention have an evidence base, they have not been tested together in an HIV context. Telehealth. The investigators will use VA Video Connect (VVC) to monitor CVD risk factors.

Specific Aims: Aim 1a: Conduct qualitative interviews with Veterans and healthcare providers to ascertain perceptions regarding HIV and CVD risk reductions to inform intervention adaptation.

Aim 1b: Adapt the intervention to the VA HIV clinic context with key stakeholder input.

Aim 2: Evaluate the 12-month efficacy of a nurse intervention to improve systolic blood pressure in Veterans with HIV. Hypothesis: The investigators hypothesize that the intervention will result in a clinically significant 6mmHg reduction in SBP over 12 months compared to those receiving [enhanced education + usual care] only. Aim 3: Conduct an evaluation of the prevention nurse intervention. Exploratory aim: If effective, [the investigators will conduct a budget impact analysis] and simulate 10-year cost-effectiveness of the nurse intervention.

Methodology: The investigators will conduct qualitative interviews with care team and Veterans to adapt the intervention in an iterative design process. The investigators will then conduct a RCT to evaluate an intervention to reduce ASCVD risk. The study will be conducted in 3 clinics among HIV+ Veterans (n=300) on suppressive antiretroviral therapy (ART) with confirmed SBP >140 mmHg, stratified by clinic site and randomized 1:1 to intervention vs. education control. The intervention will involve 4 evidence-based components based on the investigators' prior studies and adapted to Veterans with HIV: (1) nurse-led care coordination, (2) nurse-managed medication and adherence support (3) home BP monitoring, and (4) administered VA Video Connect (VVC). The education control will receive enhanced education and usual care. Primary outcome: difference in 12-month systolic BP in the intervention arm vs control. Secondary outcome: 12-month difference in non-HDL cholesterol. The investigators will use a mixed-methods design to evaluate fidelity, dose delivered/received, reach, recruitment, and context of the intervention.

Implementation/Next Steps: The investigators designed the intervention with downstream implementation in view. This includes: a fully remote delivery of the intervention to facilitate access and widespread implementation, and guidance for selection of nurses with education / experience levels that match those of health coaches delivering interventions within the VA. The investigators will work with operational partners from the Office of Connected Care and Office of HIV/AIDS care regarding implementation plans. The investigators will disseminate a clinical program, including scripts, and description of all intervention processes, to facilitate implementation within the VA.

02

Conditions studied

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

Keywords

  • HIV
  • Cardiovascular Disease
  • Medication Management
  • Care Coordination
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 305 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age => 18 years
  2. Confirmed HIV+ diagnosis
  3. 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)
  4. 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)
  5. Veteran at one of the sites participating in the study
  6. Regular access to a computer, tablet or smart phone device with internet.

Exclusion criteria

Exclusion Criteria:

  1. Severely hearing or speech impaired, or other disability that would limit participation
  2. 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
  3. In-patient psychiatric care
  4. Diagnosis of dementia or active psychosis
  5. Terminal illness with life expectancy \< 4 months (ex. Metastatic cancer, Hospice care)
  6. Recent (\<90day) hospitalization for coronary artery bypass surgery (CABG), myocardial infarction (MI), stroke)
  7. Pregnant, breast-feeding, or planning a pregnancy during the study period
  8. Planning to move out of the area in the next 12 months.
  9. No reliable access to telephone services
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
305 participants (actual)

Study 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.

    Behavioral: Intervention group

  • 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.

    Behavioral: Education control group

Interventions

  • BehavioralIntervention group

    This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)

  • BehavioralEducation control group

    This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.

06

What researchers measure

Primary outcomes

  1. Mean Systolic Blood Pressure

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

    Time frame: Baseline

  2. Mean Systolic Blood Pressure

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

    Time frame: 4 months

  3. Mean Systolic Blood Pressure

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

    Time frame: 8 months

  4. Mean Systolic Blood Pressure

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

    Time frame: 12 months

Secondary outcomes

  1. Non-HDL Cholesterol

    Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)

    Time frame: Baseline

  2. Non-HDL Cholesterol

    Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)

    Time frame: 4 months

  3. Non-HDL Cholesterol

    Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)

    Time frame: 8 months

  4. Non-HDL Cholesterol

    Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)

    Time frame: 12 months

07

Results

Posted Oct 30, 2025
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.

Participant flow

Participant flow — Overall Study
MilestoneIntervention GroupEducation Control Group
Started152149
Completed119123
Not completed3326
Withdrew: Withdrawal by subject124
Withdrew: Lost to follow-up1718
Withdrew: 12month bp not collected44

Outcome measures

PrimaryMean Systolic Blood Pressure

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

Time frame:
Baseline
Reported as:
Mean · mmHg
Mean Systolic Blood Pressure
mmHgIntervention GroupEducation Control Group
Mean Systolic Blood Pressure134.6 ± 17.3133.3 ± 15.5
PrimaryMean Systolic Blood Pressure

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

Time frame:
4 months
Reported as:
Mean · mmHg
Mean Systolic Blood Pressure
mmHgIntervention GroupEducation Control Group
Mean Systolic Blood Pressure129.7 ± 14.6129.6 ± 14.3
PrimaryMean Systolic Blood Pressure

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

Time frame:
8 months
Reported as:
Mean · mmHg
Mean Systolic Blood Pressure
mmHgIntervention GroupEducation Control Group
Mean Systolic Blood Pressure130.4 ± 14.7130.5 ± 16.6
PrimaryMean Systolic Blood Pressure

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

Time frame:
12 months
Reported as:
Mean · mmHg
Mean Systolic Blood Pressure
mmHgIntervention GroupEducation Control Group
Mean Systolic Blood Pressure130.5 ± 13.4130.6 ± 17.5
SecondaryNon-HDL Cholesterol

Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)

Time frame:
Baseline
Reported as:
Mean · mg/dL
Non-HDL Cholesterol
mg/dLIntervention GroupEducation Control Group
Non-HDL Cholesterol118.0 ± 42.6120.9 ± 38.3
SecondaryNon-HDL Cholesterol

Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)

Time frame:
4 months
Reported as:
Mean · mg/dL
Non-HDL Cholesterol
mg/dLIntervention GroupEducation Control Group
Non-HDL Cholesterol114.1 ± 51.0115.4 ± 34.8
SecondaryNon-HDL Cholesterol

Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)

Time frame:
8 months
Reported as:
Mean · mg/dL
Non-HDL Cholesterol
mg/dLIntervention GroupEducation Control Group
Non-HDL Cholesterol111.7 ± 42.9116.4 ± 37.0
SecondaryNon-HDL Cholesterol

Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)

Time frame:
12 months
Reported as:
Mean · mg/dL
Non-HDL Cholesterol
mg/dLIntervention GroupEducation Control Group
Non-HDL Cholesterol110.8 ± 39.7115.2 ± 38.6

Adverse events

Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Group3/152 (2%)18/152 (11.8%)0/152 (0%)
Education Control Group1/149 (0.7%)16/149 (10.7%)0/149 (0%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventIntervention GroupEducation Control Group
Congestive Heart Failure ExacerbationCardiac disorders3/1520/149
DeathGeneral disorders3/1521/149
GastroenteritisGastrointestinal disorders0/1522/149
Chest pain hospitalizationCardiac disorders2/1522/149
Elective surgerySurgical and medical procedures2/1522/149
GastroenteritisGastrointestinal disorders0/1522/149
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders0/1522/149
PneumoniaRespiratory, thoracic and mediastinal disorders2/1520/149
Renal failure/injuryRenal and urinary disorders2/1521/149
Defibrillator placementCardiac disorders0/1521/149

Baseline characteristics

Age, Continuous
Age, Continuous(years)Intervention GroupEducation Control GroupTotal
Mean62.1 ± 9.661.4 ± 9.461.8 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)Intervention GroupEducation Control GroupTotal
Female121123
Male140138278
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention GroupEducation Control GroupTotal
Hispanic or Latino81018
Not Hispanic or Latino139136275
Unknown or Not Reported538
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention GroupEducation Control GroupTotal
American Indian or Alaska Native202
Asian000
Native Hawaiian or Other Pacific Islander101
Black or African American118115233
White172138
More than one race91120
Unknown or Not Reported527
Region of Enrollment
Region of Enrollment(Participants)Intervention GroupEducation Control GroupTotal
United States152149301
Education
Education(Participants)Intervention GroupEducation Control GroupTotal
High school or less394180
Some college or trade school6962131
College graduate or higher444690
Employment
Employment(Participants)Intervention GroupEducation Control GroupTotal
Employed6158119
Unemployed353873
Retired5653109
08

Study locations

4 sites
  • Atlanta VA Medical and Rehab Center, Decatur, GA
    Decatur, Georgia 30033-4004, United States
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
    Baltimore, Maryland 21201, United States
  • Durham VA Medical Center, Durham, NC
    Durham, North Carolina 27705-3875, United States
  • Louis Stokes VA Medical Center, Cleveland, OH
    Cleveland, Ohio 44106-1702, United States
09

References and documents

Publications

  • 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. PubMed 37278662 ↗
  • 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. PubMed 37800987 ↗

Study documents

  • Study protocol · Sep 9, 2024
  • Statistical analysis plan · Jun 6, 2025
  • Informed consent form · Jun 9, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication and study results will be available on Clinical Trials.gov within 1 year of the final follow-up with last study participant. A local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI) prior to distribution. Data will be provided to requester in electronic form. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access.

Supporting information: Study protocol, Sap, Icf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04545489
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Sep 11, 2020
Start date
Dec 1, 2020
Primary completion
Oct 1, 2024
Completion
Mar 31, 2025
Results posted
Oct 30, 2025
Last update
Oct 30, 2025

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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