Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV (HEICA-HIV-2025)

University of Washington

Status: Not yet enrolling

Conditions: HIV; Heart Failure

Treatments: Behavioral: Mobile health support; Behavioral: Behavioral coaching; Behavioral: Exercise Intervention; Behavioral: Education sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT07105007

STUDY00022246

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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
• BMI <18 or >48
• Exercising ≥3 times per week (≥20 minutes per session)
• Use of GLP-1 or other weight loss medications, or weight loss surgery within 6 months prior to enrollment
• Do not report fatigue
• Significant comorbidities (e.g., uncontrolled hypertension, severe musculoskeletal/neurological conditions)
• Inability to undergo MRI safely
• Pregnant or postmenopausal women

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Multicomponent (physical activity, education, behavioral coaching, mobile health)

Experimental group

Description:

HEICA-HIV components will include: a) education sessions; b) exercise intervention; c) individual coaching; d) mobile health support. COMPONENT 1: Education Sessions. At the beginning of the program, the participants will receive two face-to-face group education sessions, consisting of 90 minutes of exercise and cardiovascular health education. COMPONENT 2: Exercise Intervention. After completing the education sessions, the participants will start 8 weeks of a hybrid exercise intervention, three days/week, being one supervised session in the exercise center and two unsupervised sessions at home. COMPONENT 3: Individual Coaching. At the end of their weekly in-person exercise sessions, the participants will receive a 20 min coaching session to address their attitudes, self-efficacy, and behavioral self-management skills towards exercise. COMPONENT 4: Mobile health support. At the beginning of the program, participants will receive a fitness activity tracker to help in achieving goals

Treatment:

Behavioral: Education sessions

Behavioral: Behavioral coaching

Behavioral: Exercise Intervention

Behavioral: Mobile health support