RECRUITING

Physical Activity for PLWH and Unhealthy Drinking

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Increasing Physical Activity Among Persons Living With HIV Engaged in Unhealthy Drinking

Quick Facts

Study Start:2023-02-22
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05505942

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have the ability to confirm HIV diagnosis either through visual evidence of ART medication or medical record
  2. * 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.
  3. * Have a smartphone
  4. * Considered low active: less active than the public health recommendations of 150 minutes per week of moderate intensity PA for the past 3 months
  5. * Lives in the USA
  6. * Has a U.S. mailing address
  1. * History of bipolar, schizophrenia, schizoaffective disorder or mania per self report.
  2. * History of withdrawal-related seizures or delirium tremens per self report.
  3. * Current non-pharmacological treatment for alcohol use disorder.
  4. * Unable to provide one or more individuals for follow up contact.
  5. * Current DSM-5 diagnosis of anorexia or bulimia nervosa per self report.
  6. * Marked organic impairment according to responses to the diagnostic assessments
  7. * Physical or medical problems that would not allow safe participation in a program of moderate intensity PA
  8. * Individual who is unwilling to provide their sex at birth
  9. * Limited or non-readers

Contacts and Locations

Study Contact

Michael D Stein, MD
CONTACT
617-358-1956
mdstein@bu.edu
Kara Magane, MS
CONTACT
617-358-1369
maganek@bu.edu

Principal Investigator

Michael D Stein, MD
PRINCIPAL_INVESTIGATOR
Boston University, School of Public Health - Health Law Policy & Management
Lisa Quintiliani, PhD
PRINCIPAL_INVESTIGATOR
Tufts Medical Center

Study Locations (Sites)

Boston University, Department of Medicine, remote research
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston University

  • Michael D Stein, MD, PRINCIPAL_INVESTIGATOR, Boston University, School of Public Health - Health Law Policy & Management
  • Lisa Quintiliani, PhD, PRINCIPAL_INVESTIGATOR, Tufts Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-22
Study Completion Date2026-02

Study Record Updates

Study Start Date2023-02-22
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • Lifestyle physical activity (LPA)
  • Fitbit
  • Telehealth
  • Unhealthy drinking
  • Ecological momentary assessment

Additional Relevant MeSH Terms

  • HIV
  • Physical Inactivity
  • Unhealthy Alcohol Use