An observational study in HIV Infections, Alcohol Drinking and Substance-Related Disorders, sponsored by Boston University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Boston University · Observational
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 251 is above the median of 200 across 781 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Boston University is the lead sponsor of 270 studies on the registry; 36 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Any self-reported falls
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.
Time frame: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years
Healthcare utilization
We will use self-report to measure recent emergency department use and hospitalization for falls and 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
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
Electronic records will identify falls that receive medical attention.
Time frame: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years
Self-reported fractures
Fractures, while less common than falls, are significant events that will be assessed primarily through self-report.
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 from electronic medical record review
Electronic record review, including attention to a subset associated with fragility, will identify 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
Healthcare utilization
Self-reported hospitalizations and emergency department visits will be identified using electronic medical records.
Time frame: 12-month window prior to study entry and 12-month window prior to each annual visit, for up to 3 years
Frailty
The frailty phenotype includes measures of exhaustion, low activity, weight loss, slowed walking, weak grip.
Time frame: Between study entry and final visit, measured annually, for up to 3 years
Impaired physical function
Balance, gait, strength and endurance in standing, walking, and chair rise tests, will be measured using the Short Physical Performance Battery.
Time frame: Between study entry and final visit, measured annually, for up to 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Nov 2022, 56 months.
Of 187 non-industry observational studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 56 months is above that.
Counting every sponsor, half of 201 studies reached it within 38 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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