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

Completed

Conditions studied: HIV Infections, Alcohol Drinking, Substance-Related Disorders, Bone Diseases, Falls Injury, Fractures, Bone, Injuries

In brief

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.

Key facts

Study ID

NCT03414411

Run by

Boston University

People needed

251

Starts

2018-02-20

Expected to finish

2023-04-27

Last updated by the study team

2023-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Boston University Medical Campus — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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