Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Cardiovascular Diseases (CVD); Blood Pressure; Stress

Treatments: Other: Usual Care; Behavioral: Stress Management and Resiliency Training Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06811896

IRB-300012154

1K23HL170836-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

Control

Other group

Description:

Usual Care

Treatment:

Other: Usual Care

Intervention

Other group

Description:

Adapted Intervention, Previously Established

Treatment:

Behavioral: Stress Management and Resiliency Training Program