Study protocol of a randomized controlled trial evaluating the Prime Time Sister Circles (PTSC) program's impact on hypertension among midlife African American women

BACKGROUND: The Prime-Time Sister Circles® (PTSC) program is a multifaceted, community-based peer support intervention targeting African American women who are 40 to 75 years of age. It aims to reduce hypertension disparities observed among African American women by promoting adherence to antihypertensive therapies, including lifestyle modification and therapeutic regimens. METHODS: The PTSC randomized controlled trial will evaluate the effectiveness of the PTSC Program on improved blood pressure control, healthcare utilization attributed to cardiovascular events, and healthcare costs. The study began in 2016 and will end in 2022. African American women who are 40–75 years old, have been diagnosed with hypertension, reside in Washington, D.C. or Baltimore, Maryland, and receive their care from Unity Health Care, a federally qualified health center in Washington, D.C., or Baltimore Medical System, a federally qualified health center in Baltimore, Maryland, are eligible to participate. Those randomized to the intervention group participate in the PTSC Program, which spans 13 weeks and comprises facilitator-led discussions, didactic training about hypertension management, and peer-based problem-solving concerning CVD risk factors and their amelioration. Blood pressure, weight, body mass index, waist circumference, self-reported adherence, physical activity, dietary practices, stress, and healthcare utilization data are collected at baseline, 13 weeks (end of the intervention), 9 months (months post-intervention), and 15 months (one year after the intervention). Healthcare costs will be computed at the end of the study. The study’s design is reported in the present manuscript, wherein we employed the SPIRIT checklist to guide its construction. DISCUSSION: Disparities in hypertension prevalence and management observed among mid-life African American women exist as a result of a confluence of structural determinants of health. Consequently, there is a need to develop, implement, and evaluate culturally appropriate and relevant interventions that are tailored to their lived experiences. The PTSC Trial aims to assess the impact of the program on participants’ cardiovascular, psychosocial, and cost outcomes. Its results have implications for advancing the science of designing and implementing culturally relevant interventions for African American women. TRIAL REGISTRATION: Unique identifier: NCT04371614. Retrospectively registered on April 30, 2020.