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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414411
• Other study ID #: H-35443
• Secondary ID: U01AA020784
• Status: Completed
• Start date: February 20, 2018
• Est. completion date: April 27, 2023

Study information

• Verified date: June 2023
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: April 27, 2023
• Est. primary completion date: November 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Bone Diseases
• Falls Injury
• Fractures, Bone
• HIV Infections
• Injuries
• Substance-Related Disorders
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Boston University Medical Campus	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frailty	The frailty phenotype includes measures of exhaustion, low activity, weight loss, slowed walking, weak grip.	Between study entry and final visit, measured annually, for up to 3 years
Other	Impaired physical function	Balance, gait, strength and endurance in standing, walking, and chair rise tests, will be measured using the Short Physical Performance Battery.	Between study entry and final visit, measured annually, for up to 3 years
Primary	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.	6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years
Primary	Healthcare utilization	We will use self-report to measure recent emergency department use and hospitalization for falls and fractures.	6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years
Secondary	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.	6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years
Secondary	Self-reported fractures	Fractures, while less common than falls, are significant events that will be assessed primarily through self-report.	6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years
Secondary	Fractures from electronic medical record review	Electronic record review, including attention to a subset associated with fragility, will identify self-reported fractures.	6-month window prior to study entry and 6-month window prior to each annual visit, for up to 3.5 years
Secondary	Healthcare utilization	Self-reported hospitalizations and emergency department visits will be identified using electronic medical records.	12-month window prior to study entry and 12-month window prior to each annual visit, for up to 3 years