Number of Participants per Site. This study will include a total of 2,000 African American participants. Participant recruitment will take place in participating practices, and 25 patients with uncontrolled hypertension per practice will be recruited. Because some practices in the Black Belt are very small and we wish to optimize generalizability, we will accept a total of 23 participants if recruitment has been ongoing for at least 3 months and the full target of 25 participants has not been recruited by that time point. An important aspect of a pragmatic trial is the ability to examine the heterogeneity of treatment effects in high-risk subgroups of interest that are often difficult to recruit into research studies. We preplan subgroup analyses on 1) men, 2) those younger than age 60 years, 3) those with low health literacy/numeracy, and 4) those reporting mild or greater depressive symptoms. Past reports have shown that male sex and younger age are associated with higher risk for uncontrolled CVD risk factors, and health disparities are also greatest in younger individuals.2,11 Low health literacy, numeracy and depression have also been shown to be associated with uncontrolled CVD risk factors.48-52 We will therefore recruit at least 10 men and 12 individuals younger than 60 years of age at each practice; based on our past trials, we know that mild depressive symptoms are present in 50% of this population, and health literacy is also very low. The background prevalence and oversampling of men and younger individuals will provide enough power to conduct these pre-specified subgroup analyses (see also Analysis Plan, section 8).
