Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Cohort: The 4F Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | HIV / AIDS, Hospital, Orthopedic, Psychiatric, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/24/2018 |
| Start Date: | February 20, 2018 |
| End Date: | February 2021 |
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.
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.
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.
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
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