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
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|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|
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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
|United States, Massachusetts|
|Boston University Medical Campus|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Richard Saitz, MD, MPH||Boston University|