A nurse-led intervention to extend the Veteran HIV treatment cascade for cardiovascular disease prevention (V-EXTRA-CVD)

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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. We 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, we will create a pathway for ASCVD risk reduction to be added into widespread quality improvement initiatives. Stakeholder-engaged design process. We 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 our intervention have an evidence base, they have not been tested together in an HIV context. Telehealth. We 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: We hypothesize that our 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, [we will conduct a budget impact analysis] and simulate 10-year cost-effectiveness of the nurse intervention. Methodology: We will conduct qualitative interviews with care team and Veterans to adapt the intervention in an iterative design process. We 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 our 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. We will use a mixed-methods design to evaluate fidelity, dose delivered/received, reach, recruitment, and context of the intervention. Implementation/Next Steps: We 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. We will work with operational partners from the Office of Connected Care and Office of HIV/AIDS care regarding implementation plans. We will disseminate a clinical program, including scripts, and description of all intervention processes, to facilitate implementation within the VA.