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HIV InfectionsNCT03414411

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

An observational study of HIV Infections and Alcohol Drinking, run by Boston University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
251 participants
Where
1 siteUnited States
Study dates
20 Feb 2018to 27 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston University Medical Campus

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Addressing Alcohol/HIV Consequences in Substance Dependence - Boston ARCH Cohort: The 4F Study

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.

Read the 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.

Keywords
HIV, Alcohol Use, Substance Use, Bone Disease, Falls, Fractures
Medical subject headings
HIV Infections, Alcohol Drinking, Substance-Related Disorders, Bone Diseases, Fractures, Bone, Wounds and Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years

  2. Healthcare utilization

    We will use self-report to measure recent emergency department use and hospitalization for falls and fractures.

    Measured: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years

Secondary outcomes (4)

  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

    Electronic records will identify falls that receive medical attention.

    Measured: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years

  2. Self-reported fractures

    Fractures, while less common than falls, are significant events that will be assessed primarily through self-report.

    Measured: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years

  3. Fractures from electronic medical record review

    Electronic record review, including attention to a subset associated with fragility, will identify self-reported fractures.

    Measured: 6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years

  4. Healthcare utilization

    Self-reported hospitalizations and emergency department visits will be identified using electronic medical records.

    Measured: 12-month window prior to study entry and 12-month window prior to each annual visit, for up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2018
  2. Study start20 Feb 2018
  3. Primary completion9 Nov 2022
  4. Study completion27 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03414411
Sponsor's protocol ID
H-35443
Other IDs
U01AA020784
Status last verified
Jun 2023
First submitted
30 Oct 2017
Last updated
7 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Alcohol Drinking, run by Boston University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03414411.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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