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Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an 8-week exercise program for adults age 40 or older who have HIV and are at risk for heart failure or have early heart changes. It combines exercise at a center once a week and at home twice a week with education, coaching, and mobile health support. The goal is to help people spend more time being physically active.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have HIV confirmed in your medical record.
  • Be age 40 or older.
  • Have stage A or B heart failure: risk factors or early heart changes, without heart failure symptoms.
  • Have taken HIV medicines for at least 12 months.
  • Have an HIV blood level below 200 copies/mL in the past 12 months.
  • Have not joined a structured exercise or weight loss program in the past 6 months.
  • Have a low activity level, with a score below 400 METs on the study’s physical activity questionnaire.
  • Be able to walk and do basic daily tasks without help.

Who can't join

  • Have stage C or D heart failure, which means heart failure with symptoms or advanced heart failure.
  • Have taken part in a structured exercise or weight loss program in the past 6 months.
  • Exercise at least 3 times a week for at least 20 minutes each time.
  • Do not report fatigue, or feeling tired.
  • Have other serious health problems, such as uncontrolled high blood pressure or severe muscle, bone, or nervous system conditions.
  • Be pregnant or have gone through menopause.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

WA