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

NCT03414411 | Completed DMC

• 2 other identifiers: H-35443U01AA020784
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Alcohol Drinking; Substance-Related Disorders; Bone Diseases; Falls Injury; Fractures, Bone; Injuries

Keywords

HIV; Alcohol Use; Substance Use; Bone Disease; Falls; Fractures

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• 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

  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

  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

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

• Healthcare utilization

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

Other Outcomes (2)

• Frailty

  Between study entry and final visit, measured annually, for up to 3 years

• Impaired physical function

  Between study entry and final visit, measured annually, for up to 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

HIV Infections; Alcohol Drinking; Substance-Related Disorders; Bone Diseases; Fractures, Bone; Wounds and Injuries

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Drinking Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders; Musculoskeletal Diseases

Study Officials

• Theresa W Kim, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: January 30, 2018
• Study Start: February 20, 2018
• Primary Completion: November 9, 2022
• Study Completion: April 27, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

US (1)