Behavioral program to improve heart health for people living with HIV
Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 2 sites (Seattle, Washington and 1 other locations) |
| Trial ID | NCT07105007 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seattle, Washington and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.