NCT06811896 Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk
| NCT ID | NCT06811896 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-05-14 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06811896 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06811896 currently recruiting?
Yes, NCT06811896 is actively recruiting participants. Contact the research team at jmwise@uab.edu for enrollment information.
Where is the NCT06811896 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06811896 clinical trial?
NCT06811896 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 48 participants.