Fact CheckerSign in

NCT07105007Recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
17 Jul 2025
Start date
15 Aug 2025
Primary completion date
1 Jun 2026
Lead sponsor
University of Washington
NCT number
NCT07105007

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 15 Aug 2025 to the primary completion date, 1 Jun 2026
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Heart failure stage C or D (AHA Guidelines)
  • Significant comorbidities (e.g., uncontrolled hypertension, severe musculoskeletal/neurological conditions)

Other

  • 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
  • Pregnant or postmenopausal women

Who the study is looking for

  • 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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Londrina State University
Coordinator of this site? Confirm its status
LondrinaBrazilRecruiting
University of Washington
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.