Clinical trial NCT06811896: Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk
Official title: Adapting and Piloting a Stress Management Intervention to Reduce Cardiovascular Disease Risk Among Women Living With HIV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Blood Pressure
Cardiovascular Diseases (CVD)
Keywords: stress
resiliency
meditation
blood pressure
cardiovascular risk
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-02-06
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. cis-gender females at least 18 years of age
2. HIV-seropositive and a patient of the recruiting clinic
3. English speaking

Exclusion Criteria:

1. severe mental illness
2. not being willing able to provide informed consent
3. not willing or able to attend study visits

Primary outcomes:
measure: Change in blood pressure at baseline, week 8, and week 20
timeFrame: baseline - week 8 - week 20
measure: Change in Center for Epidemiological Studies Depression Scale Score
timeFrame: baseline - week 8 - week 20
measure: Change in Generalized Anxiety Disorder-7 Scale Score
timeFrame: baseline - week 8 - week 20
measure: Changes in Perceived Stress Scale Scores
timeFrame: baseline - week 8 - week 20
measure: Changes in Connor-Davidson Resilience Scale
timeFrame: baseline - week 8 - week 20
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: