NCT05752500 · Butler Hospital
Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV
(HiActivity)
What this study is about
The goal of this clinical trial is to examine 3 interventions designed to increase physical activity in older adults with HIV. We will examine 3 potential components of an intervention package: physical activity coaching, cognitive behavioral therapy targeted toward common barriers to physical activity such as low motivation or chronic pain, and a Fitbit-based social support intervention.
View original scientific description
The goal of this clinical trial is to examine 3 interventions designed to increase physical activity in older adults with HIV. We will examine 3 potential components of an intervention package: physical activity coaching, cognitive behavioral therapy targeted toward common barriers to physical activity such as low motivation or chronic pain, and a Fitbit-based social support intervention. Our primary outcome will be physical activity, defined as steps per day. Results will guide choice of intervention components to be used in an optimized behavioral intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- HIV positive: defined by HIV antibody, detectable HIV RNA in plasma, or a note from the participant's HIV care provider.
- Must be on continuous antiretroviral therapy (ART) for \> 3 months, as assessed via self-report.
- Low PA: defined as self-report of \< 90 minutes of moderate-vigorous PA (MVPA) per week in the previous 3 months AND less than 14 hours per week of sustained walking in the previous 4 weeks.
- Medically cleared for moderate PA. If participants report a) a history of cardiovascular disease including known coronary artery disease, peripheral vascular disease, heart failure, or stroke; or b) chest pain, shortness of breath, or dizziness or syncope either at rest or during activity in the past 3 months, then they must have medical clearance by a physician or primary care provider.
- Age 50 years or older.
- Proficiency in English: sufficient to engage in informed consent, understand assessments and materials provided, and engage and use Fitbit application (all materials provided in English).
- Capacity to consent, documented by acceptable answers in a consent "teach-back" process.
- Score of greater than 16 on the MOCA
- Able to ambulate without assistive devices
- Ability to use the FitBit application, as demonstrated to study staff.
Exclusion criteria
- Medical conditions or physical or neurocognitive limitations that interfere with PA or study participation.
- Hazardous substance use, assessed via a score ≥15 on the Alcohol Use Disorders Identification Test (AUDIT) or ≥6 on the Drug Abuse Screening Test (DAST).
Where
- Minneapolis, Minnesota
- Providence, Rhode Island
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations