Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06811896

Adapting and Piloting a Stress Management Intervention to Reduce Cardiovascular Disease Risk Among Women Living With HIV

Led by University of Alabama at Birmingham · Updated on 2025-08-26

48

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Women living with HIV in the Southern United States face a significantly higher risk of cardiovascular disease compared to women without HIV. This increased risk is linked not only to traditional factors like hypertension, diabetes, and obesity but also to heightened exposure to social and structural stressors such as poverty, discrimination, and stigma. Researchers are studying the Stress Management and Resiliency Training (SMART) program, which has proven effective in reducing stress responses that contribute to cardiovascular disease. The study aims to adapt this program specifically for women living with HIV in the South to better fit their cultural and faith-based contexts and to pilot the adapted intervention for feasibility, acceptability, and preliminary impact on reducing stress and cardiovascular risk. The study compares two groups: one receiving usual care from their clinic and the other participating in the adapted SMART program. The SMART program is an evidence-based behavioral intervention delivered over eight weeks that focuses on meditation, mindfulness, and autogenic training to help participants manage their stress and improve psychological resiliency. The program works by reducing physiological stress responses that can worsen cardiovascular health. Participants will be observed and evaluated at multiple points, including baseline, week 8, and week 20. Assessments include measuring blood pressure, depression levels using the Center for Epidemiological Studies Depression Scale, anxiety using the Generalized Anxiety Disorder-7 Scale, perceived stress levels, and resilience with the Connor-Davidson Resilience Scale. The study focuses on whether the adapted program can effectively reduce stress and improve cardiovascular-related health outcomes while being acceptable and feasible for this population. The total duration of participant involvement covers these assessment points and program delivery.

CONDITIONS

Brief Title

Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Cis-gender females at least 18 years of age
  • HIV-seropositive and a patient of the recruiting clinic
  • English speaking
Not Eligible

You will not qualify if you...

  • Severe mental illness
  • Not willing or able to provide informed consent
  • Not willing or able to attend study visits

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 8 weeks

Participants undergo the Stress Management and Resiliency Training Program designed to reduce physiologic stress and cardiovascular disease risk over an 8-week period.

Weekly visits for 8 weeks

Follow-up

Duration - 12 weeks

Participants are assessed after the intervention to monitor changes in stress and cardiovascular risk factors.

Visits at week 20

Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

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Research Team

J

Jenni Wise, PhD, MSN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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