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Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Cohort: The 4F Study

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ClinicalTrials.gov Identifier: NCT03414411
Recruitment Status : Enrolling by invitation
First Posted : January 30, 2018
Last Update Posted : November 21, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Richard Saitz, Boston University

Brief Summary:

The purpose of this study is to follow a cohort of HIV-infected adults who have alcohol and/or drug use to: 1) test the associations between alcohol (and illicit drugs and polypharmacy (multiple prescribed medications)) and falls (fractures secondarily), and whether frailty mediates these associations; and 2) test the associations between alcohol (and illicit drugs and polypharmacy) and utilization (emergency department use and hospitalization for falls and fractures), and whether frailty mediates them.

To achieve the stated aims the investigators will expand (to 400) and continue to follow an existing prospective cohort (The Boston ARCH Cohort) of adults with HIV infection and a high prevalence of exposure to alcohol, other drugs, and polypharmacy. The Boston ARCH Cohort is a longitudinal cohort (1-3.5 years of follow-up) of 250 HIV-infected men and women with current substance dependence or ever injection drug use that have a spectrum of alcohol use.


Condition or disease
HIV Infections Alcohol Drinking Substance-Related Disorders Bone Diseases Falls Injury Fractures, Bone Injuries

Detailed Description:

Up to a third of middle-aged people living with HIV infection (PLWH) experience falls each year. Falls are the most common cause of non-fatal injury in the US and the cost from emergency department visits and hospitalizations are enormous. PLWH are more susceptible to falls and their serious consequences because 1) despite control of HIV viremia, inflammation persists and underlies HIV-associated comorbidities and complications that occur at a relatively young age (so-called premature aging); 2) specific comorbidities (e.g., neuropathy, osteoporosis) and complications (e.g., frailty and impaired physical function) make falls more likely and recovery from them more difficult; 3) alcohol use exacerbates inflammation, and may increase risk for comorbidities and complications; and 4) alcohol use, illicit drug use and polypharmacy can increase the likelihood of a fall. Despite this, fall prevention has not been extensively studied among PLWH. Interventions are needed to address falls in PLWH but none have been tailored for this population. Understanding risk factors and targets for intervention among PLWH are essential; cohort studies can provide the information needed for intervention development.

This study is part the Consortia for HIV/AIDS and Alcohol-Related Research Trials (CHAART). It describes the continuation and expansion of a cohort that is one of three in the Uganda Russia Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS (URBAN ARCH). The URBAN ARCH theme is to address consequences of alcohol use on HIV-associated comorbidities and complications to increase treatment availability and improve outcomes. In line with that theme the investigators will continue to follow and expand (to 400) an existing cohort of PLWH and a high prevalence of exposure to alcohol, illicit drugs, and polypharmacy (the Boston ARCH Cohort) in the Frailty, Functional impairment, Falls, and Fractures (4F study) to: (in 2 Primary Aims) 1) Test the associations between alcohol (and illicit drugs and polypharmacy) and falls (fractures secondarily); and 2) Test the associations between alcohol (and illicit drugs and polypharmacy) and acute healthcare utilization (emergency department use and hospitalization for falls and fractures). The investigators will examine the role frailty plays in these associations between alcohol, drugs and medications and the aforementioned clinical and utilization outcomes. By achieving these aims the investigators will gain substantially greater understanding of these comorbidities and complications in PLWH exposed to alcohol and other psychoactive substances; this knowledge will serve to inform the development of ways to identify, prevent and manage falls, fractures, frailty and functional impairment.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Addressing Alcohol/HIV Consequences in Substance Dependence - Boston ARCH Cohort: The 4F Study
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Any self-reported falls [ Time Frame: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years ]
    The primary outcome for Aim 1 analyses is any self-reported falls, with falls defined as an unexpected event, including a slip or trip, in which a participant lost their balance and landed on the floor, ground, or lower level, or hit an object such as a table or chair.

  2. Healthcare utilization [ Time Frame: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years ]
    We will use self-report to measure recent emergency department use and hospitalization for falls and fractures.


Secondary Outcome Measures :
  1. Falls from electronic medical record review [Time Frame: 6 months prior to study entry and prior to each annual visit] Electronic records will identify falls that receive medical attention. Falls from electronic record review [ Time Frame: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years ]
    Electronic records will identify falls that receive medical attention.

  2. Self-reported fractures [ Time Frame: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years ]
    Fractures, while less common than falls, are significant events that will be assessed primarily through self-report.

  3. Fractures from electronic medical record review [ Time Frame: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years ]
    Electronic record review, including attention to a subset associated with fragility, will identify self-reported fractures.

  4. Healthcare utilization [ Time Frame: 12-month window prior to study entry and 12-month window prior to each annual visit, for up to 3 years ]
    Self-reported hospitalizations and emergency department visits will be identified using electronic medical records.


Other Outcome Measures:
  1. Frailty [ Time Frame: Between study entry and final visit, measured annually, for up to 3 years ]
    The frailty phenotype includes measures of exhaustion, low activity, weight loss, slowed walking, weak grip.

  2. Impaired physical function [ Time Frame: Between study entry and final visit, measured annually, for up to 3 years ]
    Balance, gait, strength and endurance in standing, walking, and chair rise tests, will be measured using the Short Physical Performance Battery.


Biospecimen Retention:   Samples With DNA
saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All existing Boston ARCH Cohort participants will be offered enrollment into the 4F Study, a continuation of the Boston ARCH Cohort; additional participants will be identified from adult primary care and HIV clinics Boston Medical Center and Boston Healthcare for the Homeless Program (BHCHP).
Criteria

Inclusion Criteria:

  • Ability to speak English (fluency)
  • Willing to provide information for >1 contact person likely to know their whereabouts for follow-up.
  • Documented HIV antibody by ELISA confirmed by Western Blot or current HIV viral load greater than 10,000 (in any medical record); or HIV antibody by 4th generation ELISA confirmed by a "Multi-Spot" rapid test for discrimination of HIV-1 from HIV-2 infection and, if necessary in the case of discordant results, nucleic acid testing (NAT) for HIV-1; or any other confirmatory pathway approved by the Massachusetts Department of Public Health, U.S. Centers for Disease Control and Prevention or BMC Center for Infectious Diseases.
  • Any past 12 month use of illicit drugs, marijuana (not recommended by a healthcare provider), or nonmedical use of prescription medications (assessed using the Tobacco, Alcohol, Prescription Medication and Other Substances (TAPS) Tool); OR past 12 month alcohol use with positive AUDIT-C score (≥3 for females and ≥4 for males)
  • OR, an existing participant in the Boston ARCH Cohort

Exclusion Criteria:

  • Inability to consent or understand interview (determined by trained research assistant)
  • Under age 18
  • Plans to leave Boston area in <1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414411


Locations
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United States, Massachusetts
Boston University Medical Campus
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Richard Saitz, MD, MPH Boston University

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Responsible Party: Richard Saitz, Chair, Department of Community Health Sciences, Boston University School of Public Health, Boston University
ClinicalTrials.gov Identifier: NCT03414411     History of Changes
Other Study ID Numbers: H-35443
U01AA020784 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Saitz, Boston University:
HIV
Alcohol Use
Substance Use
Bone Disease
Falls
Fractures
Additional relevant MeSH terms:
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Bone Diseases
Substance-Related Disorders
Fractures, Bone
Alcohol Drinking
Wounds and Injuries
Chemically-Induced Disorders
Mental Disorders
Musculoskeletal Diseases
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs