Improving physical activity and reducing unhealthy drinking in people living with HIV
Increasing Physical Activity Among Persons Living With HIV Engaged in Unhealthy Drinking
This study is testing a program to help people living with HIV become more active and drink less alcohol over 12 weeks to see if it improves their overall health and well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05505942 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on enhancing physical activity levels among individuals living with HIV who engage in unhealthy drinking behaviors. Participants will be randomly assigned to either a lifestyle physical activity (LPA) program or a Fitbit-only control group over a 12-week period. The study aims to evaluate the effectiveness of the LPA intervention in reducing alcohol consumption and increasing physical activity, while also assessing its impact on mental health and coping strategies. Data will be collected through ecological momentary assessments and Fitbit tracking to monitor changes in behavior and health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals living with HIV who engage in unhealthy drinking and are considered low active.
Not a fit: Patients with a history of severe mental health disorders or those currently receiving non-pharmacological treatment for alcohol use disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the health and quality of life for individuals living with HIV by reducing unhealthy drinking and increasing physical activity.
How similar studies have performed: Previous studies have shown that physical activity interventions can effectively reduce unhealthy drinking behaviors, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Boston, Massachusetts
- Boston University, Department of Medicine, remote research — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Michael D Stein, MD — Boston University, School of Public Health - Health Law Policy & Management
- Study coordinator: Michael D Stein, MD
- Email: mdstein@bu.edu
- Phone: 617-358-1956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.