Recruiting

SMART Program

Sponsor:

University of Alabama at Birmingham

Code:

NCT06811896

Conditions

Stress

Blood Pressure

Cardiovascular Diseases (CVD)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stress Management and Resiliency Training Program

Usual Care

Study Details

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.

Conditions

Stress

Blood Pressure

Cardiovascular Diseases (CVD)

Study ID

NCT06811896

Start date

May 14, 2025

Status verified date

Aug, 2025

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Control

Usual Care

other: Intervention

Adapted Intervention, Previously Established

Interventions

Stress Management and Resiliency Training Program

The 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

Usual social and clinical services provided to patients at the recruiting clinic

Primary outcome measure

  • Change in blood pressure at baseline, week 8, and week 20 [ Time Frame: baseline - week 8 - week 20 ]
  • Change in Center for Epidemiological Studies Depression Scale Score [ Time Frame: baseline - week 8 - week 20 ]
  • Change in Generalized Anxiety Disorder-7 Scale Score [ Time Frame: baseline - week 8 - week 20 ]
  • Changes in Perceived Stress Scale Scores [ Time Frame: baseline - week 8 - week 20 ]
  • Changes in Connor-Davidson Resilience Scale [ Time Frame: baseline - week 8 - week 20 ]

Central Contacts and Locations

Central contacts

Jenni Wise, PhD, MSN

2059969459jmwise@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Jenni Wise, PhD, MSN

2059969459jmwise@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Keywords

  • stress
  • resiliency
  • meditation
  • blood pressure
  • cardiovascular risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-08-26.