NCT07105007 Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV
| NCT ID | NCT07105007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-08-15 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Vitor Oliveira, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT07105007 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07105007 currently recruiting?
Yes, NCT07105007 is actively recruiting participants. Contact the research team at andreps@uw.edu for enrollment information.
Where is the NCT07105007 trial being conducted?
This trial is being conducted at Seattle, United States, Londrina, Brazil.
Who is sponsoring the NCT07105007 clinical trial?
NCT07105007 is sponsored by University of Washington. The principal investigator is Vitor Oliveira, PhD at University of Washington. The trial plans to enroll 30 participants.
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