Study Protocol of a Randomized Controlled Trial Evaluating the Prime Time Sister Circles (PTSC) Program\u27s 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

Evaluating Depressive Symptoms among Low-Socioeconomic-Status African American Women Aged 40 to 75 Years with Uncontrolled Hypertension: A Secondary Analysis of a Randomized Clinical Trial

Importance: Depression is one of the leading causes of disability in the United States. African American women of low socioeconomic status with uncontrolled hypertension are at risk of having severe depressive symptoms, yet there is limited research about the mental health of this vulnerable population. Data from the Prime Time Sister Circles randomized clinical trial (PTSC-RCT) study can shed light on the prevalence of depressive symptoms among low-socioeconomic-status older African American women with hypertension. Objective: To determine the prevalence of depressive symptoms among low-socioeconomic-status African American women aged 40 to 75 years with uncontrolled hypertension who receive their care from a federally qualified health center (FQHC) and to identify risk factors associated with depressive symptoms. Design, Setting, and Participants: Cross-sectional analysis of data from the PTSC-RCT of depressive symptomology, measured using an adapted version of the 10-item Center for Epidemiological Studies Depression Scale Revised (CES-D-10). Descriptive statistics were used to characterize the study population. We used logistic regression models to investigate the factors associated with participants with or without symptoms of depression. We used baseline data from the PTSC-RCT study, including 316 African American English-speaking women between ages 40 and 75 years with hypertension (systolic blood pressure ≥140 mm Hg or diastolic ≥90 mm Hg), who received their primary care at a FQHC in Washington, DC, in 2017 and 2018 and were flagged by the FQHC as uncontrolled. Main Outcomes and Measures: We used the CES-D-10 from the Center for Epidemiologic Studies Depression Scale to measure presence of depressive symptoms. Results: A total of 57.0% of the women in the study (180 of 316) scored greater than or equal to 10 on the CES-D-10. Depressive symptoms had a negative association with a postsecondary education (adjusted odds ratio [aOR], 0.492; 95% CI, 0.249-0.968) and a positive association with the number of chronic conditions (aOR, 1.235; 95% CI, 1.046-1.460) and smoking (aOR, 1.731; 95% CI, 1.039-2.881). Conclusions and Relevance: In this study of low-income African American women with uncontrolled hypertension, more than half had symptoms of depression that was associated with less than high-school education, chronic conditions, and smoking. Low-income African American women with uncontrolled hypertension should be screened and adequately treated for depressive symptoms. Trial Registration: ClinicalTrials.gov Identifier: NCT04371614