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Physical Activity for PLWH and Unhealthy Drinking

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Sep 2026 to Jul 24, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 5 words
  2. Minor Primary and study completion pushed from Jul 2026 to Sep 2026v12
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 340 to confirmed 222
    • Primary and study completion dates: Feb 2026 to Jul 2026
    • Site details revised
    v11
  4. Minor Eligibility criteria shortened, about 12 wordsv10
  5. Minor Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Eligibility criteria expanded, about 13 wordsv8
  2. Minor Primary and study completion dates: Sep 2025 to Feb 2026v7
  3. Minor Site contact updatedv6
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2023 to Feb 22, 2023
    v5
  5. Notable Enrollment target: 220 to 340v4 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Interventions: Fitbit (Other), LPA Sessions (Behavioral) to Fitbit Only (Other), LPA Sessions (Behavioral)
    • Eligibility criteria shortened, about 31 words
    • Secondary endpoints: 7 to 3
    • Study description shortened, about 1 word
  6. Notable Start date: Dec 2022 to Feb 2023v3
  7. Notable Start date: Oct 2022 to Dec 2022v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05505942
Lead Sponsor Boston University
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)
HIV, Physical Inactivity, Unhealthy Alcohol Use
Related terms Sedentary Behavior
Enrollment 222 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov