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Clinical Trials/NCT06811896
NCT06811896RecruitingNot Applicable

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

University of Alabama at Birmingham1 site in 1 country48 target enrollmentStarted: May 14, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
48
Locations
1
Primary Endpoint
Change in blood pressure at baseline, week 8, and week 20

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •severe mental illness
  • •not being willing able to provide informed consent
  • •not willing or able to attend study visits

Arms & Interventions

Control

Other

Usual Care

Intervention: Usual Care (Other)

Intervention

Other

Adapted Intervention, Previously Established

Intervention: Stress Management and Resiliency Training Program (Behavioral)

Outcomes

Primary Outcomes

Change in blood pressure at baseline, week 8, and week 20

Time Frame: baseline - week 8 - week 20

Measure blood pressure at baseline, end of intervention, and at 12-week follow-up

Change in Center for Epidemiological Studies Depression Scale Score

Time Frame: baseline - week 8 - week 20

Higher score indicates more depressive symptoms (0-60 Range)

Change in Generalized Anxiety Disorder-7 Scale Score

Time Frame: baseline - week 8 - week 20

Higher scores indicate greater symptoms of anxiety (0-21 Range)

Changes in Perceived Stress Scale Scores

Time Frame: baseline - week 8 - week 20

Higher scores indicate greater perceived stress (0 - 40 Range)

Changes in Connor-Davidson Resilience Scale

Time Frame: baseline - week 8 - week 20

Higher scores indicate greater resilience (0-100 Range)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jenni Wise

Assistant Professor

University of Alabama at Birmingham

Study Sites (1)

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