About this trial
Women living with HIV have 2-4x higher risk for cardiovascular disease compared to women without HIV, with women living with HIV in the Southern US being particularly at risk. While an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence suggests that increased exposure to structural and social stressors (e.g., poverty, discrimination, and stigma) among women living with HIV in the South negatively contribute to cardiovascular disease disparities through their impact on stress. The Stress Management and Resiliency Training (SMART) program is an effective, evidence-based intervention proven to improve resiliency to environmental stressors and reduce the physiologic responses to stress which contribute to cardiovascular disease. While the SMART program has demonstrated efficacy in a wide range of populations and settings, it has not been designed for or tested among women living with HIV in the South, where unique cultural and faith-based context may diminish the uptake and value of the intervention to mitigate cardiovascular disease risk. The purpose of this study is to adapt the evidence-based SMART program in consideration of the needs and contexts of women living with HIV in the Southern US and pilot the adapted intervention to establish the feasibility, acceptability, and preliminary impact of the adapted intervention to reduce stress and mitigate cardiovascular disease risk among this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
cis-gender females at least 18 years of age
HIV-seropositive and a patient of the recruiting clinic
English speaking
Disqualifiers
severe mental illness
not being willing able to provide informed consent
not willing or able to attend study visits
Trial design
Parallel
Treatments tested in this trial
Stress Management and Resiliency Training Program
BehavioralThe Stress Management and Resiliency Training Intervention is an evidence-based intervention to reduce physiologic responses to stress that may contribute to cardiovascular disease risk. The intervention is typically delivered over an 8-week period and works to decrease stress responses by improving psychological resiliency to structural and social stressors and decreasing sympathetic nervous system activation. Eliciting the relaxation response through meditation, mindfulness, and autogenic training are core components.
Usual Care
Other interventionUsual social and clinical services provided to patients at the recruiting clinic
Treatment groups
Trial outcomes
Primary outcomes
Change in blood pressure at baseline, week 8, and week 20
Measure blood pressure at baseline, end of intervention, and at 12-week follow-up
Change in Center for Epidemiological Studies Depression Scale Score
Higher score indicates more depressive symptoms (0-60 Range)
Change in Generalized Anxiety Disorder-7 Scale Score
Higher scores indicate greater symptoms of anxiety (0-21 Range)
Changes in Perceived Stress Scale Scores
Higher scores indicate greater perceived stress (0 - 40 Range)
Sponsors and contacts
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University of Alabama at Birmingham
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator