Adapting and Piloting a Stress Management Intervention to Reduce Cardiovascular Disease Risk Among Women Living With HIV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change in blood pressure at baseline, week 8, and week 20
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •cis-gender females at least 18 years of age
- •HIV-seropositive and a patient of the recruiting clinic
- •English speaking
Exclusion Criteria
- •severe mental illness
- •not being willing able to provide informed consent
- •not willing or able to attend study visits
Arms & Interventions
Control
Usual Care
Intervention: Usual Care (Other)
Intervention
Adapted Intervention, Previously Established
Intervention: Stress Management and Resiliency Training Program (Behavioral)
Outcomes
Primary Outcomes
Change in blood pressure at baseline, week 8, and week 20
Time Frame: baseline - week 8 - 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
Time Frame: baseline - week 8 - week 20
Higher score indicates more depressive symptoms (0-60 Range)
Change in Generalized Anxiety Disorder-7 Scale Score
Time Frame: baseline - week 8 - week 20
Higher scores indicate greater symptoms of anxiety (0-21 Range)
Changes in Perceived Stress Scale Scores
Time Frame: baseline - week 8 - week 20
Higher scores indicate greater perceived stress (0 - 40 Range)
Changes in Connor-Davidson Resilience Scale
Time Frame: baseline - week 8 - week 20
Higher scores indicate greater resilience (0-100 Range)
Secondary Outcomes
No secondary outcomes reported
Investigators
Jenni Wise
Assistant Professor
University of Alabama at Birmingham
