Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV
Recruiting · NCT07105007 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Washington
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Heart failure (HF) is a growing health and economic burden around the globe, and it remains a leading cause of morbidity and mortality among the general population. HIV is recognized as an independent risk factor for HF, due to direct and indirect effects. Furthermore, people living with HIV (PLWH) now have an increased life expectancy due to the evolution and widespread use of antiretroviral therapy (ART), leading to a rising burden of cardiovascular disease (CVD) and HF among this population. Yet, the provision of appropriate guideline-recommended cardiovascular care is lower in PLWH compared to the general population, and there are no studies testing HF prevention interventions focused on PLWH. Current guidelines for HF management highlight the importance of a healthy lifestyle in preventing and treating HF. Among PLWH, tailored, innovative, and sustainable exercise delivery models are necessary to overcome barriers and increase physical activity (PA) adherence in this population. Building on the research team's prior mixed methods work and research expertise on exercise trials for PLWH, the investigators propose the Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV). HEICA-HIV is a novel multi-component 8-week intervention that will simultaneously deliver a supervised center-based (once a week) and a tailored home-based (twice a week) exercise intervention, together with exercise and cardiovascular health education. It will also involve behavioral coaching and mobile health support. The investigators evidence suggests that, by providing weekly exercise supervision together with a home-based prescription, the investigators can overcome difficulties associated with home-based programs (e.g., less intensive exercise training, less social support, and less face-to-face monitoring), and still observe the augmented health benefits obtained from supervised programs. Additionally, by requiring less time at the training center, this hybrid model can help with time restraints and transportation issues affecting marginalized populations, potentially increasing long-term exercise adherence in those who need it most. In this initial stage, HEICA-HIV will be focused on improving time in moderate-to-vigorous physical activity (MVPA). International guidelines recommend that every adult should engage in at least 150 minutes of MVPA per week in order to achieve optimal health benefits.
Who can take part
Inclusion criteria
- Confirmed HIV infection (verified on medical record)
- Age ≥40 years
- Classified as heart failure stage A or B (American Heart Association Guidelines)
- On antiretroviral therapy (ART) for ≥12 months
- HIV RNA \<200 copies/mL in the past 12 months
- Not engaged in a structured exercise or weight loss program in the past 6 months
- Physically inactive, defined as an activity level of less than 400 METs measured with the Global Physical Activity Questionnaire (GPAQ)
- Independent in basic activities of daily living
- Able to ambulate independently
Exclusion criteria
- Heart failure stage C or D (AHA Guidelines)
- Participating in structured exercise or weight loss program in the past 6 months
- Exercising ≥3 times per week (≥20 minutes per session)
- Do not report fatigue
- Significant comorbidities (e.g., uncontrolled hypertension, severe musculoskeletal/neurological conditions)
- Pregnant or postmenopausal women
Where it is running
2 locations listed across 1 US state.
- University of Washington - Seattle, Washington, United States
- Londrina State University - Londrina, Paraná, Brazil