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Search / Trial NCT05505942

Physical Activity for PLWH and Unhealthy Drinking

Launched by BOSTON UNIVERSITY · Aug 16, 2022

Trial Information

Current as of August 27, 2025

Recruiting

Keywords

Lifestyle Physical Activity (Lpa) Fitbit Telehealth Unhealthy Drinking Ecological Momentary Assessment

ClinConnect Summary

This clinical trial is studying how physical activity can help people living with HIV (PLWH) who also struggle with unhealthy drinking habits. Unhealthy drinking can make health problems worse for those with HIV, so the researchers want to see if a home-based program that encourages physical activity can improve their overall health and reduce alcohol use. Participants will be randomly assigned to one of two groups: one group will receive extra support and guidance to increase their physical activity, while the other group will only use a Fitbit to track their daily steps with minimal help.

To join the study, participants must confirm they have HIV and report unhealthy drinking habits, such as exceeding a certain number of drinks per week. They should also have a smartphone and be less active than the recommended amount of exercise. The trial will last 12 weeks, and participants will have follow-up assessments three and six months later to see how they are doing. This study is currently recruiting participants, and it aims to provide valuable insights into how physical activity can positively affect the health of people living with HIV.

Gender

ALL

Eligibility 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

About Boston University

Boston University, a leading research institution located in Boston, Massachusetts, is dedicated to advancing health sciences through innovative clinical trials and research initiatives. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive network of experts and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes and addressing pressing health challenges. Boston University is committed to ethical research practices, patient safety, and the dissemination of findings to foster greater understanding and advancements in medical care.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Michael D Stein, MD

Principal Investigator

Boston University, School of Public Health - Health Law Policy & Management

Lisa Quintiliani, PhD

Principal Investigator

Tufts Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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