Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT07105007

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

Led by University of Washington · Updated on 2026-03-16

30

Participants Needed

2

Research Sites

45 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

F

Fred Hutchinson Cancer Center

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed HIV infection (verified on medical record)
  • Age 40 years or older
  • Classified as heart failure stage A or B (American Heart Association Guidelines)
  • On antiretroviral therapy (ART) for at least 12 months
  • HIV RNA less than 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 less than 400 METs measured with the Global Physical Activity Questionnaire (GPAQ)
  • Independent in basic activities of daily living
  • Able to ambulate independently
Not Eligible

You will not qualify if you...

  • Heart failure stage C or D (American Heart Association Guidelines)
  • Participating in a structured exercise or weight loss program in the past 6 months
  • Exercising 3 or more times per week for 20 minutes or more per session
  • Do not report fatigue
  • Significant comorbidities such as uncontrolled hypertension, severe musculoskeletal or neurological conditions
  • Pregnant or postmenopausal women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

2

Londrina State University

Londrina, Paraná, Brazil, 86055

Actively Recruiting

Loading map...

Research Team

A

André Pereira dos Santos, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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