HIVNCT05505942
Physical Activity for PLWH and Unhealthy Drinking
A study testing LPA Sessions and Fitbit Only in people with HIV and Physical Inactivity, run by Boston University at 1 site in United States.
Trial summary
Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Physical Inactivity, Unhealthy Alcohol Use
- What is being tested?
- LPA Sessions and Fitbit Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 24 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the ability to confirm HIV diagnosis either through visual evidence of ART medication or medical record
- Engaged in unhealthy drinking, defined as: >7 drinks for women / > 14 drinks for men per week OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month.
- Have a smartphone
- Considered low active: 150 minutes or less of average weekly physical activity
- Lives in the USA
- Has a U.S. mailing address
Who cannot join
- History of bipolar, schizophrenia, schizoaffective disorder or mania per self report.
- History of withdrawal-related seizures or delirium tremens per self report.
- Current non-pharmacological treatment for alcohol use disorder.
- Unable to provide one or more individuals for follow up contact.
- Current DSM-5 diagnosis of anorexia or bulimia nervosa per self report.
- Marked organic impairment according to responses to the diagnostic assessments
Show all 9Show fewer
- Physical or medical problems that would not allow safe participation in a program of moderate intensity PA
- Individual who is unwilling to provide their sex at birth
- Limited or non-readers
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University, Department of Medicine, remote research
Boston, Massachusetts, 02118
About this study
Official title: Increasing Physical Activity Among Persons Living With HIV Engaged in Unhealthy Drinking
Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Antiretroviral therapy (ART) has shown increasing life expectancy and decreased HIV-related deaths, leading to a growing older adult HIV population. Yet, HIV accelerates the aging process and increases the risk for numerous chronic health conditions that compromise physical and mental health functioning and quality of life. Thus, PLWH continue to have shorter life expectancies relative to the general population and these multimorbidities explain this increased risk. In this context, unhealthy alcohol use among PLWH can further increase the risk for negative outcomes.
Physical activity (PA) interventions can be used as an effective way to address unhealthy alcohol use among PLWH. Previous PA interventions have shown low generalizability and high loss to follow-up. Therefore, an intervention that is home-based, including lifestyle physical activity (LPA) with mobile health-delivered components is designed following the physical activity (PA) paradigm.
Read more
Participants in this randomized controlled trial will be assigned to one of two study arms -- either the LPA or Fitbit Only intervention - both lasting 12-weeks. Both study arms will utilize a Fitbit to track daily step counts.
In addition to utilizing a Fitbit, the LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine.
The Fitbit only arm will receive only brief check-in phone calls and only related to assisting with any Fitbit functioning issues.
Follow-up assessments will take place at 3 and 6 months.
Read the detailed description
Primary Aims - Physical Activity and Drinking Outcomes
To test the efficacy of a 12-week LPA intervention among low-active, PLWH engaged in unhealthy drinking. Participants will be randomly assigned to either: (a) LPA or (b) Fitbit Only control condition. Relative to Fitbit Only, the investigators hypothesize that:
- LPA will demonstrate decreases in unhealthy drinking (i.e., drinks/week) end-of-treatment (EOT) and 3 months later (i.e., 6-month follow-up).
- LPA will demonstrate higher objective-determined physical activity engagement (i.e., steps/day) at the EOT and at the 6-month follow-up.
Secondary Aims - Physical and Mental Health Functioning Outcomes Relative to Fitbit Only or LPA will result in decreased negative affect and sedentary behavior (i.e., minutes spent sitting/day), heavy drinking days, alcohol-related problems, and increases in adaptive coping, PA self-efficacy, PA motivation, and physical/mental functioning at EOT and 6-month follow-ups.
Tertiary Aims - Examining Mechanisms
- Decreases in negative affect and increases in adaptive coping during the intervention period will mediate the relationship between LPA and drinking outcomes at the 6-month follow-up
- Increases in PA self-efficacy and motivation will mediate the effect of LPA on PA engagement
- Utilizing Ecological momentary assessment (EMA) and Fitbit data, we hypothesize higher negative affect and urges to drink earlier in the day is more likely to increase the likelihood of engaging in bouts of PA later in the day at EOT, relative to baseline, and among persons randomized to LPA versus Fitbit Only.
- Conditions
- HIV, Physical Inactivity, Unhealthy Alcohol Use
- Being tested
- LPA Sessions, Fitbit Only
- Keywords
- Lifestyle physical activity (LPA), Fitbit, Telehealth, Unhealthy drinking, Ecological momentary assessment
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPA SessionsBehavioural
A study interventionist will conduct phone/video sessions and provide information regarding the acute and long-term psychological and physical benefits of increasing PA. Participants will be introduced to the concept of utilizing brief bouts of PA as a coping strategy for managing emotions and urges to drink alcohol "in-the-moment". Participants will also be given information on the public health guidelines for PA (and how these translate into step counts) as well as how to determine if their PA is moderate intensity (e.g., measuring heart rate and identifying rate of perceived exertion). Study clinicians will also orient participants to the proper use of the Fitbit activity tracker and tips for self-monitoring step counts with the tracker and on the app and/or website.
Fitbit OnlyOther
Interventionists will provide participants information about the proper use of the Fitbit activity tracker and offer tips for self-monitoring step counts with the tracker and on the app and/or website.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Physical Activity (LPA) | Experimental | The LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine. Receives: Behavioral: LPA Sessions |
| Fitbit Only | Active comparator | The Fitbit only arm will receive only brief check in phone calls and only related to assisting with any Fitbit functioning issues. Receives: Other: Fitbit Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in steps per day at 6-month follow up
Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit.
Measured: 6 months
Change in number of alcohol drinks consumed per week
Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.
Measured: 6 months
Secondary outcomes (3)
Change in steps per day at 3-month follow up
Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit.
Measured: 3 months
Change in alcohol drinks consumed per week
Assessed by the Timeline Follow Back (TLBF-30) which is a is a calendar that allows a clinician to obtain an estimate of an individual's daily drinking habits over a given time period.
Measured: baseline
Changes in theoretically-relevant psychosocial factors including: negative affect, physical activity self-efficacy, physical activity motivation, alcohol-related problems, and time spent sitting
Assessed via self-report measures.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start22 Feb 2023
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization procedures to the two groups will apply sex at birth (male/female) and body mass index (greater than or equal to 30 or less than 30) as blocking variables.
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Michael D Stein, MD, Principal investigator, Boston University, School of Public Health - Health Law Policy & ManagementLisa Quintiliani, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505942
- Sponsor's protocol ID
- H-42543
- Other IDs
- 1P01AA029546-01
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abrantes AM, Ferguson E, Stein MD, Magane KM, Fielman S, Karzhevsky S, Flanagan A, Siebers R, Quintiliani LM. Design and rationale for a randomized clinical trial testing the efficacy of a lifestyle physical activity intervention for people with HIV and engaged in unhealthy drinking. Contemp Clin Trials. 2024 Sep;144:107632. doi: 10.1016/j.cct.2024.107632. Epub 2024 Jul 15.
PubMed 39019155
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity Among Persons Living With HIV Engaged in Unhealthy Drinking
- ClinicalTrials.gov ID
- NCT05505942
- Acronym / sponsor ID
- H-42543
- Conditions
- HIV, Physical Inactivity, Unhealthy Alcohol Use
- Keywords
- Lifestyle physical activity (LPA), Fitbit, Telehealth, Unhealthy drinking, Ecological momentary assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 18 Aug 2022 (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.
Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Antiretroviral therapy (ART) has shown increasing life expectancy and decreased HIV-related deaths, leading to a growing older adult HIV population. Yet, HIV accelerates the aging process and increases the risk for numerous chronic health conditions that compromise physical and mental health functioning and quality of life. Thus, PLWH continue to have shorter life expectancies relative to the general population and these multimorbidities explain this increased risk. In this context, unhealthy alcohol use among PLWH can further increase the risk for negative outcomes.
Physical activity (PA) interventions can be used as an effective way to address unhealthy alcohol use among PLWH. Previous PA interventions have shown low generalizability and high loss to follow-up. Therefore, an intervention that is home-based, including lifestyle physical activity (LPA) with mobile health-delivered components is designed following the physical activity (PA) paradigm.
Participants in this randomized controlled trial will be assigned to one of two study arms -- either the LPA or Fitbit Only intervention - both lasting 12-weeks. Both study arms will utilize a Fitbit to track daily step counts.
In addition to utilizing a Fitbit, the LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine.
The Fitbit only arm will receive only brief check-in phone calls and only related to assisting with any Fitbit functioning issues.
Follow-up assessments will take place at 3 and 6 months.
Detailed description
Primary Aims - Physical Activity and Drinking Outcomes
To test the efficacy of a 12-week LPA intervention among low-active, PLWH engaged in unhealthy drinking. Participants will be randomly assigned to either: (a) LPA or (b) Fitbit Only control condition. Relative to Fitbit Only, the investigators hypothesize that:
- LPA will demonstrate decreases in unhealthy drinking (i.e., drinks/week) end-of-treatment (EOT) and 3 months later (i.e., 6-month follow-up).
- LPA will demonstrate higher objective-determined physical activity engagement (i.e., steps/day) at the EOT and at the 6-month follow-up.
Secondary Aims - Physical and Mental Health Functioning Outcomes Relative to Fitbit Only or LPA will result in decreased negative affect and sedentary behavior (i.e., minutes spent sitting/day), heavy drinking days, alcohol-related problems, and increases in adaptive coping, PA self-efficacy, PA motivation, and physical/mental functioning at EOT and 6-month follow-ups.
Tertiary Aims - Examining Mechanisms
- Decreases in negative affect and increases in adaptive coping during the intervention period will mediate the relationship between LPA and drinking outcomes at the 6-month follow-up
- Increases in PA self-efficacy and motivation will mediate the effect of LPA on PA engagement
- Utilizing Ecological momentary assessment (EMA) and Fitbit data, we hypothesize higher negative affect and urges to drink earlier in the day is more likely to increase the likelihood of engaging in bouts of PA later in the day at EOT, relative to baseline, and among persons randomized to LPA versus Fitbit Only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization procedures to the two groups will apply sex at birth (male/female) and body mass index (greater than or equal to 30 or less than 30) as blocking variables.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Physical Activity (LPA) | Experimental | Behavioral: LPA SessionsThe LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine. |
| Fitbit Only | Active comparator | Other: Fitbit OnlyThe Fitbit only arm will receive only brief check in phone calls and only related to assisting with any Fitbit functioning issues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have the ability to confirm HIV diagnosis either through visual evidence of ART medication or medical record
- Engaged in unhealthy drinking, defined as: >7 drinks for women / > 14 drinks for men per week OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month.
- Have a smartphone
- Considered low active: 150 minutes or less of average weekly physical activity
- Lives in the USA
Key exclusion criteria (9 listed)
- History of bipolar, schizophrenia, schizoaffective disorder or mania per self report.
- History of withdrawal-related seizures or delirium tremens per self report.
- Current non-pharmacological treatment for alcohol use disorder.
- Unable to provide one or more individuals for follow up contact.
- Current DSM-5 diagnosis of anorexia or bulimia nervosa per self report.
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 |
|---|---|---|
| LPA SessionsA study interventionist will conduct phone/video sessions and provide information regarding the acute and long-term psychological and physical benefits of increasing PA. Participants will be introduced to the concept of utilizing brief bouts of PA as a coping strategy for managing emotions and urges to drink alcohol "in-the-moment". Participants will also be given information on the public health guidelines for PA (and how these translate into step counts) as well as how to determine if their PA is moderate intensity (e.g., measuring heart rate and identifying rate of perceived exertion). Study clinicians will also orient participants to the proper use of the Fitbit activity tracker and tips for self-monitoring step counts with the tracker and on the app and/or website. | Behavioural | Lifestyle Physical Activity (LPA) |
| Fitbit OnlyInterventionists will provide participants information about the proper use of the Fitbit activity tracker and offer tips for self-monitoring step counts with the tracker and on the app and/or website. | Other | Fitbit Only |
Primary outcome
Change in steps per day at 6-month follow up
Time frame: 6 months
Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit.
Change in number of alcohol drinks consumed per week
Time frame: 6 months
Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.
3 secondary outcomes
Change in steps per day at 3-month follow up
Time frame: 3 months
Change in alcohol drinks consumed per week
Time frame: baseline
Changes in theoretically-relevant psychosocial factors including: negative affect, physical activity self-efficacy, physical activity motivation, alcohol-related problems, and time spent sitting
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Derived from this study: PubMed 39019155Abrantes AM, Ferguson E, Stein MD, Magane KM, Fielman S, Karzhevsky S, Flanagan A, Siebers R, Quintiliani LM. Design and rationale for a randomized clinical trial testing the efficacy of a lifestyle physical activity intervention for people with HIV and engaged in unhealthy drinking. Contemp Clin Trials. 2024 Sep;144:107632. doi: 10.1016/j.cct.2024.107632. Epub 2024 Jul 15.
- 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. This study is not recruiting at the moment.
Michael D Stein, MD principal investigator
Boston University, School of Public Health - Health Law Policy & Management
Lisa Quintiliani, PhD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LPA Sessions and Fitbit Only in people with HIV and Physical Inactivity, run by Boston University at 1 site 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in steps per day at 6-month follow up (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05505942, which also lists 1 linked publication.
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 1 Oct 2026.