Behavioral program to improve heart health for people living with HIV
Official title: Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV
Run by University of Washington · NCT07105007 · Data updated 2026-11-12
This program will test a tailored exercise, education, coaching, and mobile support package to improve heart health in people age 40 and older living with HIV who are classified as heart failure stage A or B.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 2 sites (Seattle, Washington and 1 other locations) |
| Status | Recruiting |
| Started | August 15, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | July 1, 2026 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT07105007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are people living with HIV aged 40 or older who have been on ART for at least 12 months, have HIV RNA <200 copies/mL in the past year, are classified as HF stage A or B, are physically inactive, and can ambulate and perform basic daily activities independently.
✕Probably not a fit
People with symptomatic (stage C or D) heart failure, significant uncontrolled comorbidities, pregnant or postmenopausal women, those already in structured exercise or weight-loss programs, or those unable to ambulate independently are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial enrolls adults 40 and older living with HIV who are on antiretroviral therapy, virally suppressed, and classified as American Heart Association stage A or B heart failure but who are currently physically inactive. Participants receive a tailored exercise program, structured education sessions, behavioral coaching, and mobile health support to increase physical activity and promote guideline-recommended cardiovascular care. The intervention combines in-person and remote components designed to overcome barriers to exercise adherence and sustain lifestyle change. Investigators will track changes in physical activity, cardiovascular risk markers, and the feasibility and acceptability of the approach as a proof-of-concept.
Why it matters
Potential benefit: If successful, the program could lower future heart failure risk and improve cardiovascular fitness and quality of life for people living with HIV.
How similar studies have gone: Exercise and behavioral programs have improved cardiovascular outcomes in the general population, but there have been no prior heart-failure prevention interventions specifically focused on people living with HIV, making this a novel proof-of-concept.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Washington
Seattle, Washington, United States Recruiting -
Londrina State University
Londrina, Paraná, Brazil Recruiting
Study contacts
- Principal investigator: Vitor Oliveira, PhD — University of Washington
- Study coordinator: André Pereira dos Santos, PhD
- Email: andreps@uw.edu
- Phone: 206-380-3048
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.