Behavioral Intervention for Cardiovascular Health in HIV/AIDS

(HEICA-HIV-2025 Trial)

Not yet recruiting at 1 trial location

Overseen By André Pereira dos Santos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must be taking: Antiretroviral therapy

Must not be taking: GLP-1, Weight loss medications

Disqualifiers: Heart failure stage C/D, Uncontrolled hypertension, Severe conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve heart health in people living with HIV by testing a new exercise program called the Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV). The program combines center-based and home workouts with coaching, health education, and mobile support to make exercise easier and more effective. It targets individuals with HIV who are not currently active and have managed their condition with medication for at least a year. Participants should not be involved in structured exercise or weight loss programs. The goal is to help participants become more active and improve their heart health over the 8-week period. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research aimed at enhancing heart health in the HIV community.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have been on antiretroviral therapy (ART) for at least 12 months to participate.

What prior data suggests that this behavioral intervention is safe for cardiovascular health in people living with HIV?

Research has shown that exercise programs can be safe and beneficial for people living with HIV. For example, a review of studies found that activities like aerobic exercises and strength training improve heart health without major risks. Most participants handle these exercises well, with few reports of serious side effects.

The Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV) includes both supervised and at-home exercises, along with education, coaching, and mobile health support. This program aims to increase physical activity safely and manageably. Participants in similar programs often find them safe and effective for improving fitness and heart health. The mix of supervised and home exercises helps keep risks low while maximizing benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV) because it offers a comprehensive approach to improving heart health by combining physical activity, education, coaching, and technology. Unlike traditional cardiovascular treatments that might focus solely on medication, this intervention empowers individuals by integrating personalized coaching and tracking through a fitness activity tracker. This holistic strategy not only aims to boost cardiovascular health but also enhances participants' self-management skills and motivation, potentially leading to more sustainable lifestyle changes.

What evidence suggests that the Hybrid Exercise Intervention is effective for cardiovascular health in people living with HIV?

Research has shown that exercise programs for people with HIV can improve walking ability and heart health. Studies have found that supervised aerobic exercise enhances lung, heart, and mental health in this population. The Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV) trial combines supervised and at-home exercises. This mix addresses common challenges such as lack of support and transportation. By including education and coaching, the program encourages regular exercise and aims to improve heart health in those at risk of heart problems. This approach aligns with international guidelines recommending at least 150 minutes of moderate exercise each week for health benefits. ^{1 5 6 7 8}

Who Is on the Research Team?

Vitor Oliveira, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for people living with HIV who are at risk of heart failure. Participants should be interested in improving their cardiovascular health through exercise and education, willing to receive behavioral coaching, and able to use mobile health support tools.

Inclusion Criteria

My heart condition is in the early stages according to AHA guidelines.

I have a confirmed HIV infection.

HIV RNA <200 copies/mL in the past 12 months

Exclusion Criteria

My BMI is either below 18 or above 48.

I cannot safely have an MRI.

I am currently pregnant or have gone through menopause.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education

Participants receive two face-to-face group education sessions on exercise and cardiovascular health

1 week

2 visits (in-person)

Treatment

Participants undergo an 8-week hybrid exercise intervention with supervised and home-based sessions, along with individual coaching and mobile health support

8 weeks

8 visits (in-person), 16 sessions (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV)

Trial Overview The HEICA-HIV program is being tested. It's an 8-week intervention combining supervised center-based exercise once a week, tailored home-based exercises twice a week, educational sessions on exercise and heart health, behavioral coaching, plus mobile health support.

How Is the Trial Designed?

Group I: Multicomponent (physical activity, education, behavioral coaching, mobile health) Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Fred Hutchinson Cancer Center

Collaborator

Trials

583

Recruited

1,341,000+

State University of Londrina

Collaborator

Trials

1

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07105007

Study Details | NCT07105007 | Proof-of-concept of a ... HEICA-HIV is a novel multi-component 8-week intervention that will simultaneously deliver a supervised center-based (once a week) and a tailored ...

2. withpower.com withpower.com/trial/phase-heart-failure-7-2025-4a645

Behavioral Intervention for Cardiovascular Health in HIV ... This trial is for people living with HIV who are at risk of heart failure. ... Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9317429/

Effects of Physical Activity Interventions on Health Outcomes ... These findings suggest that physical activity interventions for people living with HIV aged ≥50 years are effective for the improvement of walking capacity.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07130045?aggFilters=status%3A

Study Details | Hybrid Exercise Program for Heart Disease A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/25787489.2022.2054397

Full article: Impact of supervised aerobic exercise on ... In conclusion, performing supervised, continuous aerobic exercise, appears to lead in pulmonary, cardiorespiratory and mental health improvements in PLWH, while ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12368329/

A hybrid simulation model of HIV program interventions The impact of HIV/AIDS on children's educational outcome: a critical review of global literature. AIDS Care 2012; 24(8): 993–1012. [DOI] ...

7. greenlighthealth.com greenlighthealth.com/portfolio/hct/

HCT (HIV Youth to Adult Care Transition) HCT is a multilevel mHealth intervention designed to support youth living with HIV and their pediatric/adolescent and adult care providers. Principle ...

8. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2025.1602007/pdf

Qualitative insights from an online community-based ... HIV/AIDS, exercise, interviews, community-based research, qualitative research ... health-affecting-people-living-hiv- · aids.html (Accessed ...