Design of a randomized controlled trial using a community–academic partnership to improve medication adherence: MI-CARE study protocol and implementation

The prevalence of hypertension has been observed to be disproportionately higher among African American and other minoritized populations compared with White Americans. Persistent compounding factors such as sociocultural barriers and medication nonadherence among minoritized populations exacerbate hypertension and cardiovascular disease disparities. The "My Interprofessional Care team for Adherence and Research Engagement (MI-CARE)" intervention focused on collaborative, culturally responsive tailoring of healthcare provision to improve medication adherence. A social-ecological framework was used to design the MI-CARE intervention to address patient needs at multiple levels of influence on medication adherence and delivered by a pharmacist-community health worker team. An intention-to-treat randomized controlled trial (RCT) at a federally qualified health center tested the effectiveness of this team-based, comprehensive care intervention through 6 months post-randomization, compared with usual care, in two minoritized cultural groups: African American and Latino/a. This study assessed pre- to post-intervention changes in medication adherence (proximal outcome), blood pressure (distal outcome), and other comorbid health variables (distal outcomes). To do so, we collected self-reported medication adherence, manual pill count, and blood pressure data at baseline and at 2.5 months and 6 months post-randomization. We also aimed to identify factors associated with intervention effectiveness, including tailored intervention features, intervention dose, medication beliefs, barriers to adherence, and health literacy. Throughout the study, the interprofessional research team's adaptability and responsiveness supported the implementation of this RCT within a real-world clinical setting. Insights from advances and challenges in clinical operations informed adaptations that strengthened healthcare delivery while maintaining research integrity.