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, evaluation integrated viral load suppression, and retention in are among PLWH. of the clinica l effectiveness, economic impact, and scalability of pharmacist-led interventions in HIV and CVD care in SSA are still understudied. c However, 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 in western Kenya. 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), patient-reported 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 disability-adjusted 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 SBP 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 diverse and complementary expertise. Data generated from our study will provide important policy guidance for President'sEmergency Plan for AIDS Relief (PEPFAR)supported countries trying to address the growing burden of ASCVD amongst the adult and aging population with HIV and will provide rigorous evidence on the roles of clinical pharmacists in chronic disease management in sub-Saharan Africa.
