INTEGRATE RX: Integrating Clinical Pharmacists in HIV care to Mitigate Last-Mile Challenges and Reduce Cardiovascular Disease Burden - PROJECT SUMMARY/ABSTRACT Primary prevention and treatment for CVD risk factors, particularly hypertension, diabetes, and hyperlipidemia, are crucial in the comprehensive management and CVD risk reduction among persons living with HIV (PLWH). Clinical pharmacists and their involvement in HIV care through comprehensive medication management lead to improved medication adherence, viral load suppression, and retention in care among PLWH. However, evaluation of the clinical effectiveness, economic impact, and scalability of pharmacist-led interventions in integrated HIV and CVD care are still understudied. The overall objective of this proposal is to evaluate the effectiveness and cost-effectiveness of a multi-component implementation strategy to prevent and manage cardiovascular disease in PLWH. Our central hypothesis is that a pharmacist-led intervention (INTEGRATE-RX) which includes – (1) integration of clinical pharmacists for CVD medication initiation and maintenance, (2) pharmacist-coordinated access to CVD essential medicines, and (3) pharmacist-coordinated peer support for medication delivery and psychosocial counseling – will be clinically effective and cost-effective in improving CVD outcomes amongst PLWH. In Aim 1, we will design a pharmacist-led HIV/CVD integrated care implementation strategy. Using a human-centered design approach, we will refine a pharmacist-led multicomponent cardiovascular risk reduction intervention to enhance HIV/CVD care. We will evaluate the acceptability and appropriateness of the implementation strategy amongst patients, pharmacists, physicians, other providers, peers, and administrators. In Aim 2, we will evaluate the clinical effectiveness by conducting an implementation hybrid type 2 stepped-wedge clustered randomized controlled trial comparing: INTEGRATE-RX implementation strategy and usual care. The primary clinical outcome will be one-year change in SBP. The primary adherence outcome will be medication adherence. The primary implementation outcome will be fidelity. Secondary outcomes will include change in viral load, low-density lipoprotein (LDL), patientreported quality of life, and RE-AIM metrics. In Aim 3, we will estimate the cost-effectiveness and budget impact of INTEGRATE-RX in terms of cost per patient with controlled hypertension and per disabilityadjusted life year (DALY) saved. To assess the financial impact of adopting this high-value intervention, we will estimate the incremental cost per unit reduction in systolic blood pressure and per DALY saved, compared to usual care. We will model the budget impact of increasing intervention coverage to 50% of the eligible population by 2030 to promote wider county-level adoption. The research will be conducted by a transdisciplinary team with complementary expertise. Data generated from our study will have direct impact and benefit on the PLWH populations in the US, who face rising cardiovascular risks, medication access barriers, and behavioral challenges with long-term medication adherence. The study will also provide rigorous evidence on the expanding roles of clinical pharmacists in chronic disease management of HIV and CVD in the US and globally.
