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

Abstract

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.

The impact of the Prime Time Sister Circles® (PTSC) on blood pressure of low-income mid-life African American women in the United States

“…This study analyzes data collected as part of a larger randomized clinical trial that evaluates the effectiveness of the Prime Time Sister Circles® (PTSC) on health, health care utilization, and behavioral outcomes. Details of the PTSC-RCT have been provided elsewhere [ 17 , 18 ]. The PTSC-RCT’s primary outcome was hypertension control, and it aimed to assess the impact of the PTSC intervention on hypertension.…”

“…The GPHIC trained PTSC facilitators on cardiovascular conditions, group facilitation and leadership, and on cultural beliefs undergirding self-management of chronic conditions. The facilitators were PTSC program graduates who resided in the communities the program serves [ 17 ]. Each Sister Circle is composed of 25–30 mid-life African American women (with mid-life defined as ages 40–75, in accordance with Gaston and Porter’s designation).…”

“…A trained assistant read the survey item by item and recorded the participant’s response. We previously described some of these outcomes [ 17 ].…”

Handling missing data in partially clustered randomized controlled trials.

“…To illustrate the discrepancy across different missing data handling methods (LD, three methods of MI, and the SFB method with two types of priors) in detecting treatment effects in PC-RCTs, we used data from the Prime Time Sister Circle (PTSC) study (Gabriel et al, 2021; Ibe et al, 2021). The PTSC study is a RCT that aims to evaluate the effectiveness of the PTSC program—a community-based peer support intervention that empowers mid- to late-life African American women to proactively manage their blood pressure, through culturally rooted educational, behavioral, and psychosocial approaches targeting modifiable risk factors associated with hypertension.…”

Evaluating the Impact of the Prime Time Sister Circles® Intervention on Reducing Depressive Symptoms Among African American Women with Uncontrolled Hypertension

“… 14 Yet, despite indication suggesting a strong link between high blood pressure and depression, 30 , 31 AA women whose health care entails ongoing monitoring of their blood pressure may not be receiving adequate care for their depression; 32 indeed, only a third of AA adults experiencing mental illness received services in 2019. 33 …”