Recruitment and enrollment of African Americans and Caucasians in a health promotion trial for persons with serious mental illness.

African Americans with serious mental illness (SMI) continue to experience inadequate representation in clinical trials. Persons with SMI, regardless of race, have an increased burden of all cardiovascular disease (CVD) risk factors including obesity, hypertension, diabetes mellitus, dyslipidemia, metabolic syndrome and tobacco smoking. Having SMI and being African American, however, is each associated with an increased risk of CVD mortality compared to the general population. There is a critical need, therefore, to adapt health promotion interventions for African Americans with SMI. We sought to examine overall recruitment into a randomized clinical trial of CVD prevention among persons with SMI, and to examine racial differences in interest, enrollment, and potential barriers to participation. Although similar levels of interest in participation were seen between African Americans and Caucasians in signing screening consent, 9.6% fewer African Americans enrolled due to inability to complete initial data collection. Further work is needed to better understand the nature of the barriers encountered by African Americans with SMI who otherwise may be interested in participating within clinical trials.