HivHiActivityNCT05752500
Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV
A study testing Cognitive Behavioral Intervention for Physical Activity, Social Support for Physical Activity and Physical Activity Coaching in people with Hiv and Physical Inactivity, run by Butler Hospital at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hiv, Physical Inactivity, Aging
- What is being tested?
- Cognitive Behavioral Intervention for Physical Activity, Social Support for Physical Activity and Physical Activity Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jun 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 54415
Nwando Ikeogu, 612-449-5974
Jason Baker, MD
- Recruiting
Brown University Health
Providence, Rhode Island, 02904
Lizzie Cepeda, BA, 401-793-8870
Megan Pinkston-Camp, PhD
About this study
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.
Read the detailed description
Increasing numbers of persons living with HIV (PLWH) are living to older ages. Older PLWH are at increased risk for a wide spectrum of co-morbid conditions such as cardiovascular disease, frailty phenotype, and mental health disorders. Practical primary care-based interventions are needed for older PLWH that target lifestyle factors to reduce complications of aging and improve healthspan. Most PLWH engage in less physical activity (PA) than is recommended by public health guidelines. Thus, increasing PA can lead to numerous mental and physical health benefits among PLWH. Current studies in PLWH typically focus on the impact of supervised exercise. However, there are many barriers to this type of PA. Lifestyle physical activity (LPA) programs that focus on integrating PA, especially walking, into everyday life, may be more successful in producing a sustained increase in PA. The long-term goal of this research is to develop an effective and efficient primary care intervention that increases LPA among older PLWH. We leverage the Multiphase Optimization STrategy (MOST) as a framework for developing, optimizing, and evaluating a multicomponent behavioral intervention. MOST is comprised of three phases. First, in the preparation phase, an empirical and theory-driven conceptual model is developed that identifies differentiable intervention components and specifies optimization criteria (i.e., goal of intervention development). We have completed this phase. Second, in the optimization phase, the impact of each intervention component on the desired outcome is empirically examined. The goal is to determine which components to include in a final intervention package that is optimized for efficacy and efficiency. The proposed study reflects the second phase, or an optimization trial. Finally, in the evaluation phase, the optimized intervention package is evaluated for efficacy in a traditional RCT; this will be the next step in this line of research following the currently proposed project. In this project, we will test the impact of three separable intervention components on steps per day after 4 months of intervention. We will recruit 196 PLWH of age ≥50 year classified as low-active. All participants receive component '0': brief advice to exercise and a Fitbit activity tracker. We then test 3 additional components in a factorial design: 1) PA Coaching-focused on goal-setting and self-monitoring; 2) Cognitive-Behavioral intervention for PA (CB-PA)-focused on identifying values and addressing internal barriers to PA such as pain, depression, or fatigue; 3) Social Support for PA (SS-PA)-a component which leverages the social functionality of the Fitbit app, promoting social support and friendly competition. The primary outcome will be steps per day during Month 4. The observed main and interaction effects for the 3 candidate components will guide selection of components to be included in an optimized intervention that will be tested in a future RCT. We will also examine potential mediators for each intervention component, as well as secondary outcomes including perceived physical health, mental health, cardiovascular disease risk, and the frailty phenotype.
- Conditions
- Hiv, Physical Inactivity, Aging
- Being tested
- Cognitive Behavioral Intervention for Physical Activity, Social Support for Physical Activity, Physical Activity Coaching, Brief Advice and Self-Monitoring
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Intervention for Physical ActivityBehavioural
Also called CB- PA
Interventionist will use cognitive and behavioral techniques to help the participant increase facilitators and decrease barriers to physical activity, particularly barriers such as lack of motivation, depression, and chronic pain. Meetings will occur every other week for 4 months.
Social Support for Physical ActivityBehavioural
Also called SS-PA
This component will leverage the social functionality of the Fitbit app, promoting social support and friendly competition via a moderated Facebook group.
Physical Activity CoachingBehavioural
Also called PA Coaching
The PA coach will meet with the participant to set goals for physical activity (steps) and encourage self-monitoring. Meetings will occur every other week for 4 months.
Brief Advice and Self-MonitoringBehavioural
Also called BASM
Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.
| Study group | Role | What they receive |
|---|---|---|
| BASM + PA Coaching | Experimental | Brief Advice and Self-Monitoring Physical Activity Coaching Receives: Behavioral: Physical Activity Coaching; Behavioral: Brief Advice and Self-Monitoring |
| BASM + CB-PA | Experimental | Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Receives: Behavioral: Cognitive Behavioral Intervention for Physical Activity; Behavioral: Brief Advice and Self-Monitoring |
| BASM + SS-PA | Experimental | Brief Advice and Self-Monitoring Social support for Physical Activity Receives: Behavioral: Social Support for Physical Activity; Behavioral: Brief Advice and Self-Monitoring |
| BASM + PA Coaching + CB-PA | Experimental | Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity Receives: Behavioral: Cognitive Behavioral Intervention for Physical Activity; Behavioral: Physical Activity Coaching; Behavioral: Brief Advice and Self-Monitoring |
| BASM + PA Coaching + SS-PA | Experimental | Brief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity Receives: Behavioral: Social Support for Physical Activity; Behavioral: Physical Activity Coaching; Behavioral: Brief Advice and Self-Monitoring |
| BASM + CB-PA + SS-PA | Experimental | Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity Receives: Behavioral: Cognitive Behavioral Intervention for Physical Activity; Behavioral: Social Support for Physical Activity; Behavioral: Brief Advice and Self-Monitoring |
| BASM + PA Coaching + CB-PA + SS-PA | Experimental | Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity Receives: Behavioral: Cognitive Behavioral Intervention for Physical Activity; Behavioral: Social Support for Physical Activity; Behavioral: Physical Activity Coaching; Behavioral: Brief Advice and Self-Monitoring |
| BASM | Other | Brief Advice and Self-Monitoring Receives: Behavioral: Brief Advice and Self-Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps per day
Assessed via Fitbit
Measured: Month 4
Secondary outcomes (7)
Minutes per week of moderate-vigorous activity
Assessed via FitBit
Measured: Month 4
Minutes per week of moderate-vigorous activity, self-report
Assessed via the International Physical Activity Questionnaire
Measured: Month 4
Frailty Phenotype
Assessed via the Fried Criteria
Measured: Month 4
CVD Risk
Assessed using Life's Simple 7 Scale
Measured: Month 4
Physical performance
Assessed via the Short Physical Performance Battery
Measured: Month 4
Emotional Well-being
Assessed via PROMIS-29 v2.1 profile - Mental Health summary score
Measured: Month 4
Physical functioning
Assessed via PROMIS-29 v2.1 profile - Physical Health summary score
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start21 Jun 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2x2 factorial design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Uebelacker, PhD, Principal investigator, Butler HospitalJason Baker, MD, Principal investigator, Hennepin Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752500
- Sponsor's protocol ID
- 2208-002
- Acronym
- HiActivity
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV
- ClinicalTrials.gov ID
- NCT05752500
- Acronym / sponsor ID
- HiActivity / 2208-002
- Conditions
- Hiv, Physical Inactivity, Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Increasing numbers of persons living with HIV (PLWH) are living to older ages. Older PLWH are at increased risk for a wide spectrum of co-morbid conditions such as cardiovascular disease, frailty phenotype, and mental health disorders. Practical primary care-based interventions are needed for older PLWH that target lifestyle factors to reduce complications of aging and improve healthspan. Most PLWH engage in less physical activity (PA) than is recommended by public health guidelines. Thus, increasing PA can lead to numerous mental and physical health benefits among PLWH. Current studies in PLWH typically focus on the impact of supervised exercise. However, there are many barriers to this type of PA. Lifestyle physical activity (LPA) programs that focus on integrating PA, especially walking, into everyday life, may be more successful in producing a sustained increase in PA. The long-term goal of this research is to develop an effective and efficient primary care intervention that increases LPA among older PLWH. We leverage the Multiphase Optimization STrategy (MOST) as a framework for developing, optimizing, and evaluating a multicomponent behavioral intervention. MOST is comprised of three phases. First, in the preparation phase, an empirical and theory-driven conceptual model is developed that identifies differentiable intervention components and specifies optimization criteria (i.e., goal of intervention development). We have completed this phase. Second, in the optimization phase, the impact of each intervention component on the desired outcome is empirically examined. The goal is to determine which components to include in a final intervention package that is optimized for efficacy and efficiency. The proposed study reflects the second phase, or an optimization trial. Finally, in the evaluation phase, the optimized intervention package is evaluated for efficacy in a traditional RCT; this will be the next step in this line of research following the currently proposed project. In this project, we will test the impact of three separable intervention components on steps per day after 4 months of intervention. We will recruit 196 PLWH of age ≥50 year classified as low-active. All participants receive component '0': brief advice to exercise and a Fitbit activity tracker. We then test 3 additional components in a factorial design: 1) PA Coaching-focused on goal-setting and self-monitoring; 2) Cognitive-Behavioral intervention for PA (CB-PA)-focused on identifying values and addressing internal barriers to PA such as pain, depression, or fatigue; 3) Social Support for PA (SS-PA)-a component which leverages the social functionality of the Fitbit app, promoting social support and friendly competition. The primary outcome will be steps per day during Month 4. The observed main and interaction effects for the 3 candidate components will guide selection of components to be included in an optimized intervention that will be tested in a future RCT. We will also examine potential mediators for each intervention component, as well as secondary outcomes including perceived physical health, mental health, cardiovascular disease risk, and the frailty phenotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 8
- Model description
- 2x2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| BASM + PA Coaching | Experimental | Behavioral: Physical Activity Coaching, Behavioral: Brief Advice and Self-MonitoringBrief Advice and Self-Monitoring Physical Activity Coaching |
| BASM + CB-PA | Experimental | Behavioral: Cognitive Behavioral Intervention for Physical Activity, Behavioral: Brief Advice and Self-MonitoringBrief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity |
| BASM + SS-PA | Experimental | Behavioral: Social Support for Physical Activity, Behavioral: Brief Advice and Self-MonitoringBrief Advice and Self-Monitoring Social support for Physical Activity |
| BASM + PA Coaching + CB-PA | Experimental | Behavioral: Cognitive Behavioral Intervention for Physical Activity, Behavioral: Physical Activity Coaching, Behavioral: Brief Advice and Self-MonitoringBrief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity |
| BASM + PA Coaching + SS-PA | Experimental | Behavioral: Social Support for Physical Activity, Behavioral: Physical Activity Coaching, Behavioral: Brief Advice and Self-MonitoringBrief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity |
| BASM + CB-PA + SS-PA | Experimental | Behavioral: Cognitive Behavioral Intervention for Physical Activity, Behavioral: Social Support for Physical Activity, Behavioral: Brief Advice and Self-MonitoringBrief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity |
| BASM + PA Coaching + CB-PA + SS-PA | Experimental | Behavioral: Cognitive Behavioral Intervention for Physical Activity, Behavioral: Social Support for Physical Activity, Behavioral: Physical Activity Coaching, Behavioral: Brief Advice and Self-MonitoringBrief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity |
| BASM | Other | Behavioral: Brief Advice and Self-MonitoringBrief Advice and Self-Monitoring |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Intervention for Physical ActivityAlso: CB- PAInterventionist will use cognitive and behavioral techniques to help the participant increase facilitators and decrease barriers to physical activity, particularly barriers such as lack of motivation, depression, and chronic pain. Meetings will occur every other week for 4 months. | Behavioural | BASM + CB-PA, BASM + CB-PA + SS-PA, BASM + PA Coaching + CB-PA, BASM + PA Coaching + CB-PA + SS-PA |
| Social Support for Physical ActivityAlso: SS-PAThis component will leverage the social functionality of the Fitbit app, promoting social support and friendly competition via a moderated Facebook group. | Behavioural | BASM + CB-PA + SS-PA, BASM + PA Coaching + CB-PA + SS-PA, BASM + PA Coaching + SS-PA, BASM + SS-PA |
| Physical Activity CoachingAlso: PA CoachingThe PA coach will meet with the participant to set goals for physical activity (steps) and encourage self-monitoring. Meetings will occur every other week for 4 months. | Behavioural | BASM + PA Coaching, BASM + PA Coaching + CB-PA, BASM + PA Coaching + CB-PA + SS-PA, BASM + PA Coaching + SS-PA |
| Brief Advice and Self-MonitoringAlso: BASMParticipants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit. | Behavioural | BASM, BASM + CB-PA, BASM + CB-PA + SS-PA, BASM + PA Coaching, BASM + PA Coaching + CB-PA, BASM + PA Coaching + CB-PA + SS-PA, BASM + PA Coaching + SS-PA, BASM + SS-PA |
Primary outcome
Steps per day
Time frame: Month 4
Assessed via Fitbit
7 secondary outcomes
Minutes per week of moderate-vigorous activity
Time frame: Month 4
Minutes per week of moderate-vigorous activity, self-report
Time frame: Month 4
Frailty Phenotype
Time frame: Month 4
CVD Risk
Time frame: Month 4
Physical performance
Time frame: Month 4
Emotional Well-being
Time frame: Month 4
Physical functioning
Time frame: Month 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Uebelacker, PhD principal investigator
Butler Hospital
Jason Baker, MD principal investigator
Hennepin Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Intervention for Physical Activity, Social Support for Physical Activity and Physical Activity Coaching in people with Hiv and Physical Inactivity, run by Butler Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bailey O'Keeffe, MS (401-455-6219, bokeeffe@butler.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps per day (time frame: Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.