Physical Activity for PLWH and Unhealthy Drinking

Running, not enrolling · Not applicable

Conditions studied: HIV, Physical Inactivity, Unhealthy Alcohol Use

In brief

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.

Key facts

Study ID: NCT05505942
Run by: Boston University
People needed: 222
Starts: 2023-02-22
Expected to finish: 2026-09-01
Last updated by the study team: 2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
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

Where it is running

Boston University, Department of Medicine, remote research — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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