NCT05505942Completed
Physical Activity for PLWH and Unhealthy Drinking
Increasing Physical Activity Among Persons Living With HIV Engaged in Unhealthy Drinking
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 222 (actual)
- First submitted
- 16 Aug 2022
- Start date
- 22 Feb 2023
- Primary completion date
- 24 Jul 2026
- Lead sponsor
- Boston University
- Diseases
- HIV
- NCT number
- NCT05505942
What you commit to
- Study type: Interventional
- Participants enrolled: 222
- From 22 Feb 2023 to the primary completion date, 24 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Marked organic impairment according to responses to the diagnostic assessments
Other
- Unable to provide one or more individuals for follow up contact.
- Current DSM-5 diagnosis of anorexia or bulimia nervosa per self report.
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston University, Department of Medicine, remote research Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.