Clinical trial NCT04545489: A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention
Official title: A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention (V-EXTRA-CVD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Hypertension
Care Coordination
HIV Treatment Cascade
Keywords: HIV
Cardiovascular Disease
Medication Management
Care Coordination
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-09-11
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 RCT, the investigators hypothesize that the VA adapted nurse-led intervention will result in a clinically significant 6mmHg reduction in 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.

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 HSR\&D 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 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.

Eligibility criteria: 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 smartphone device with internet.

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 CABG, 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

Primary outcomes:
measure: Mean Systolic Blood Pressure
timeFrame: Baseline
measure: Mean Systolic Blood Pressure
timeFrame: 4 months
measure: Mean Systolic Blood Pressure
timeFrame: 8 months
measure: Mean Systolic Blood Pressure
timeFrame: 12 months
Secondary outcomes:
measure: Non-HDL Cholesterol
timeFrame: Baseline
measure: Non-HDL Cholesterol
timeFrame: 4 months
measure: Non-HDL Cholesterol
timeFrame: 8 months
measure: Non-HDL Cholesterol
timeFrame: 12 months
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Hayden B Bosworth, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Puja Van Epps, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.