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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Brazil
Londrina State University
RECRUITING
Londrina
Contact Information
Primary
André Pereira dos Santos, PhD
andreps@uw.edu
206-380-3048
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 30
Treatments
Experimental: Multicomponent (physical activity, education, behavioral coaching, mobile health)
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
Other: Control group
Participants randomized allocated to the control group will receive a standardized, guideline-based exercise counseling comparator designed to reflect best-practice health education rather than the multicomponent HEICA-HIV program. Control participants will complete one brief education session delivered at baseline, covering exercise safety and general physical activity recommendations. Following education, participants will receive a non-individualized, generic home-based exercise recommendation emphasizing aerobic and resistance activities, without supervised training, structured progression, individualized feedback, or behavioral coaching. Control participants will not receive motivational interviewing support. Although formal exercise prescription is not routinely provided in standard HIV care, inclusion of general exercise counseling in the control condition is ethically appropriate, given the well-established benefits of physical activity.
Related Therapeutic Areas
Sponsors
Collaborators: Fred Hutchinson Cancer Center, State University of Londrina
Leads: University of Washington

This content was sourced from clinicaltrials.gov