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NCT05505942 · ClinicalTrials.gov registry record · NA
Physical Activity for PLWH and Unhealthy Drinking
A NA study of HIV and Physical Inactivity, sponsored by Boston University.
- Active
- Registry status
- NA
- Development phase
- 222
- Enrollment target
- 1
- Study location
NCT05505942: Active NA study of HIV and Physical Inactivity, sponsored by Boston University.
NCT05505942 is a NA study of HIV and Physical Inactivity that is active but no longer recruiting, run by Boston University. The registered enrollment target is 222 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05505942, a NA study of HIV and Physical Inactivity, is active but no longer recruiting, sponsored by Boston University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 222 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Physical activity (PA) will be assessed via steps per day as collected by a participant's Fitbit.
Conditions Studied
Interventions
- BEHAVIORAL LPA Sessions
- OTHER Fitbit Only
Study Locations (1)
Massachusetts
- Boston University, Department of Medicine, remote research - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2023-02-22 |
| Est. Completion | 2026-07 |
| Phase | NA |
What the registry record for NCT05505942 still lists
NCT05505942 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 303 other HIV trials with a reported enrollment target (49% lower).
The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which LPA Sessions is the first listed.
NCT05505942 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05505942 about?
NCT05505942 is a clinical study titled "Physical Activity for PLWH and Unhealthy Drinking". 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. Anti...
What is the current status of trial NCT05505942?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 222 participants. The study started on 2023-02-22. Estimated completion is 2026-07.
What conditions does trial NCT05505942 study?
This clinical trial studies the following conditions: HIV, Physical Inactivity, Unhealthy Alcohol Use.
What interventions are being tested in trial NCT05505942?
The interventions under investigation include: LPA Sessions (BEHAVIORAL), Fitbit Only (OTHER).
Who is sponsoring clinical trial NCT05505942?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05505942 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05505942's enrollment target sits among peer trials
222 95th of 303 higher than 209 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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