Check, Monitor, Control Hypertension in Older African American Adults (#Check, Monitor, Control): Protocol for a Randomized Clinical Trial (Preprint)

BACKGROUND African Americans (AAs) experience higher rates of hypertension (HTN) and related cardiovascular and stroke mortality compared with the general U.S. population. Interestingly, studies have shown that AAs take more antihypertensive medications but are less likely to adhere to the prescribed medication regimens compared to the general population. Additionally, participants in qualitative studies have expressed that HTN self-management, particularly lifestyle modifications, should receive more attention than increasing medications. OBJECTIVE The objectives of this study are: 1) to evaluate the synergistic effect of a pharmacist and community health worker (Pharm+CHW) intervention compared to a Pharmacist alone (Pharm control group) to improve blood pressure (BP) control in a predominantly AA cohort aged ≥ 55 years in a prospective randomized trial (n=480); 2) to identify factors correlated with clinical BP outcomes. METHODS This is a randomized clinical trial to investigate novel behavioral intervention strategies targeting HTN self-management (e.g., medication management, blood pressure monitoring) and lifestyle modifications. The study has two components: a pharmacist-led medication management component (Pharm) and a community health worker support component (CHW). In the Pharm component, pharmacists will provide virtual Medication Therapy Management (MTM) services, which include: a comprehensive medication review, recommendations for lifestyle modifications, blood pressure self-monitoring education, and medication management app education. In the CHW component, CHW will support participants’ self-initiation of behavioral change(s), address challenges to lifestyle modification, and provide health education through workshops. The study intervention will be guided by a Community Advisory Board (CAB) consisting of six members. The study will recruit a cohort of 480 predominantly AA adults 55 years or older with HTN through community-and faith-based organizations and clinics in Houston, Texas, U.S. Participants will be prospectively randomized to one of the two parallel groups: 1) Pharmacist alone (control group; n=240); or 2) Pharmacist and CHW interventions (Pharm+CHW; n=240) for 24 months. Computer-generated randomization, with 1:1 allocation stratified by age, recruitment site, and HTN stage, will be applied. The primary self-monitoring BP outcome will be measured at 0-, 6-, 12-, 18-, and 24-months to evaluate the effectiveness of the proposed interventions. The secondary outcomes will include medication adherence, hypertension knowledge, perceived competency, body mass index, and physical activity. RESULTS The study was funded by the National Institute on Minority Health and Health Disparities of the National Institutes of Health under award number 2U54MD007605 in September 2025. The CAB has convened and offered support for recruitment efforts. Recruitment is ongoing, and the intervention is expected to begin in summer 2026. CONCLUSIONS This project will fill an important knowledge gap regarding the synergistic effect of CHWs working in collaboration with pharmacists to help older adults use technologies (e.g., virtual visits, mobile medication management apps) and initiate lifestyle modifications for HTN self-management in older adult AAs. CLINICALTRIAL NCT07413159