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Behavioral Intervention for Cardiovascular Health in People Living With HIV

This study is testing a behavioral intervention to improve heart health in people living with HIV (PLWH) who also have early-stage heart failure. The intervention includes tailored education sessions, behavioral coaching, and an exercise program with both supervised and at-home sessions. You would also receive a fitness tracker (like a Fitbit) for mobile health support. The goal is to see if these interventions can help you be more active and reduce sedentary (sitting) time over 8 weeks. To join, you need to be at least 40 years old, have confirmed HIV infection with a controlled viral load, and have heart failure stage A or B. This study plans to enroll 30 participants.

Study design
This is an interventional study with 30 planned participants, but the phase and status are not specified. It is testing a behavioral intervention.
What's involved
You would participate in two face-to-face group education sessions, followed by 8 weeks of a hybrid exercise intervention (one supervised session and two at-home sessions per week). You would also receive weekly 20-minute coaching sessions and a fitness activity tracker.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured from enrollment to the end of the 8-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07105007

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

Recruiting
NAAges 40+InterventionalSupportive care
University of Washington
~30 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:Exercise InterventionTailored Education sessionsBehavioral coachingMobile health supportGeneral education

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intervention Adherence
Measured over From enrollment to the end of treatment at 8 weeks
+3 more outcomes measured

Conditions

HIV
Heart Failure

Explore related trials

Heart FailureHIV InfectionHIV Infection

Where it's being run

2 sites across 2 states
Washington1
Paraná1

Study leadership

  • Vitor Oliveira, PhD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

André Pereira dos Santos, PhD
[email protected]
206-380-3048
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Intervention AdherenceFrom enrollment to the end of treatment at 8 weeks

    Description: Number of exercise and education sessions attended by each participant during the intervention. Unit of Measure: Number of sessions attended

  • Time Spent in Sedentary BehaviorFrom enrollment to the end of treatment at 8 weeks

    Description: Exploratory analysis of the average time spent in sedentary behavior per week. Unit of Measure: Minutes per week

  • Daily Step CountFrom enrollment to the end of treatment at 8 weeks

    Description: Exploratory outcome assessing the average daily number of steps. Unit of Measure: Steps per day

  • Moderate to Vigorous Physical Activity (MVPA) TimeFrom enrollment to the end of treatment at 8 weeks

    Description: The primary outcome will be the objectively measured amount of time (in minutes) spent in moderate to vigorous physical activity (MVPA) per week. Assessment Method: Using the wGT3X-BT ActiGraph accelerometer (ActiGraph, LLC, Fort Walton Beach, FL), participants will wear the device for 7 consecutive days during waking hours. Data will be considered valid with at least 10 hours/day of wear time for at least 4 days. Data Processing: Data will be reduced using ActiLife software and MVPA will be classified based on Sasaki et al. adult cutpoints. Unit of Measure: Minutes per week