Clinical trial Recruiting at 2 sites Interventional Ages 40 and up

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.

More Heart Failure trials

Quick facts

Study typeInterventional
Ages40 Years and up
SexAll
Enrollment30 (estimated)
SponsorUniversity of Washington
Academic / other
Locations2 sites (Seattle, Washington and 1 other locations)
StatusRecruiting
StartedAugust 15, 2025
Main results expectedJune 1, 2026
Study endsJuly 1, 2026
Registry record updatedMarch 16, 2026
Trial IDNCT07105007 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

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.