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CompletedNCT01740115Updated Sep 12, 2016

Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Cohort

An observational study in HIV Infection, Alcohol Use and Bone Disease, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-12.

Sponsored by Boston Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to expand and continue a cohort of HIV-infected adults to establish the longitudinal Boston ARCH Cohort of 250 HIV-infected men and women with current substance dependence or ever injection drug use that have a spectrum of alcohol use; and to determine the effect of alcohol consumption on changes in bone health prospectively in the Cohort.

Read the detailed description

Unhealthy alcohol use (i.e. the spectrum ranging from heavy drinking that risks health consequences to dependence) is common among HIV-infected persons and is associated with worse health outcomes among people with HIV infection. However, much remains unknown about alcohol-related health effects in those affected by multiple drugs (particularly opioids), or about specific health effects such as detriment to bone. Alcohol use can disrupt bone remodeling by suppressing formation and increasing resorption; heavy alcohol use is associated with both osteopenia (low bone mineral density [BMD]) and incidence of fractures. Osteopenia is common among HIV-infected patients, and fractures are more common in these patients than among adults without HIV infection. Duration of HIV infection has been found to be associated with low BMD, and antiretroviral therapy (ART) also appears to be associated with BMD decline. While bone health is likely affected by HIV infection, ART, alcohol and other drug (e.g. opioid) use (in addition to other known risk factors), the alcohol-osteopenia association among those with HIV infection is not well-characterized. It is not known whether there is an association, the magnitude and nature of that association, and how the relationship is affected by other commonly co-occurring factors (e.g. opioid use, ART).

Accordingly, as part of the Uganda Russia Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS (URBAN ARCH) Consortium, we seek to expand and continue a cohort of HIV-infected adults to establish the Boston ARCH Cohort of 250 HIV-infected adults affected by multiple substances and that have a spectrum of alcohol use. This observational prospective cohort study will involve in-person assessments that will take place at 6-month intervals; participants will be followed for a minimum of 1 year and a maximum of 3.5 years. All assessments will include a researcher-administered questionnaire and breath alcohol test. In addition, the baseline assessment and each annual assessment (12, 24 or 36 months after enrollment) will also include: a urine pregnancy test (females only), blood collection, measurement of bone mineral density of the hip and spine (using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry [Bone Densitometer]), and measurement of bone microarchitecture of the wrist and ankle (using Xtreme CT [a device that measures high-resolution three-dimensional peripheral quantitative computed tomography]). We will conduct laboratory tests on blood samples collected at these time points, including tests for 25(OH) vitamin D3 and phosphatidylethanol (PEth). Remaining plasma and serum samples will be stored for future study of bone markers such as: parathyroid hormone, testosterone, carboxy-terminal collagen crosslinks (CTX) (a marker of osteoclast activity), and osteocalcin (osteoblast activity).

In summation, this study will measure the effect of alcohol consumption on changes in bone health prospectively in HIV-infected adults with current substance dependence or ever injection drug use. To our knowledge, no other prospective HIV/bone study has studied these relevant factors simultaneously or used HR-pQCT to assess bone microarchitecture. Data on alcohol risks to bone health is important information for defining risky drinking amounts for people with HIV infection (and for advising such patients accordingly).

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Conditions studied

  • HIV Infection
  • Alcohol Use
  • Bone Disease
  • Substance-Related Disorders

Keywords

  • HIV
  • Alcohol Use
  • Bone Disease
  • Bone Mineral Density
  • Bone Microarchitecture
  • Substance Dependence
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In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 250 is above the median of 200 across 731 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.

Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects from an existing cohort of HIV-infected adults (Facilitated Access to Substance Abuse Treatment With Prevention and Treatment of HIV [FAST PATH]) who have indicated interest in future studies and patients from HIV clinical care sites will be recruited.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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 Boston Medical Center, Center for Infectious Diseases.
  2. Current (12-month) substance dependence, determined by using the Mini International Neuropsychiatric Interview (MINI) or ever injection drug use (IDU)
  3. Ability to speak English (fluency)
  4. At least one contact person who is likely to know whereabouts (to assist with follow-up)

Exclusion criteria

Exclusion Criteria:

  1. Under age 18
  2. Pregnancy (confirmed by urine test)
  3. Plans to leave Boston area in \<1 year
  4. Inability to consent or understand interview (determined by trained research assistant)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (actual)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Annual mean percent change in hip (femoral neck) bone mineral density (g/cm2)

    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 13.4.2 (Bone Densitometer)

    Time frame: Between study entry and final visit (minimum of 12 months)

Secondary outcomes

  1. Annual mean percent change in spine (trabecular bone) bone mineral density (g/cm2)

    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 13.4.2 (Bone Densitometer) Safety Issue?: No

    Time frame: Between study entry and final visit (minimum of 12 months)

  2. Proportion with bone mineral density decrease of >6%

    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 13.4.2 (Bone Densitometer)

    Time frame: Between study entry and final visit (minimum of 12 months)

  3. Proportion with osteopenia (bone mineral density t score -1 to -2.5 SDs compared to a young adult reference population mean)

    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 13.4.2 (Bone Densitometer)

    Time frame: Between study entry and final visit (minimum of 12 months)

  4. Proportion of osteoporosis (bone mineral density t score <-2.5 SDs compared to a young adult reference population mean)

    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 13.4.2 (Bone Densitometer)

    Time frame: Between study entry and final visit (minimum of 12 months)

  5. Fractures (vertebral, hip, wrist)

    Self-report of ever fracture at each site (vertebral, hip, wrist) and fracture in past 12-months collected at baseline and each annual time point.

    Time frame: 12 months prior to study entry through final visit

  6. Annual mean percent change in bone mineral density (g/cm2) at site with lowest bone mineral density (spine [trabecular bone] or hip [femoral neck])

    Bone mineral density will be measured using Hologic QDR 4500W enhanced-array, whole-body, dual-energy radiographic absorptiometry scanner and software, version 13.4.2 (Bone Densitometer)

    Time frame: Between study entry and final visit (minimum of 12 months)

Other outcomes

  1. Bone mineral density, bone mineral content, trabecular thickness, separation and number, volume fraction and cortical thickness

    Exploratory outcomes will be assessed using HR-pQCT (wrist and ankle)

    Time frame: Between study entry and final visit (minimum of 12 months)

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Study locations

1 site
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01740115
Responsible party
Richard Saitz (Chair, Department of Community Health Sciences, Professor of Community Health Sciences and Medicine, Boston University Schools of Medicine and Public Health, Boston Medical Center) — Principal investigator
First posted
Dec 4, 2012
Start date
Nov 2012
Primary completion
Mar 2016
Completion
Aug 2016
Last update
Sep 12, 2016

Study contacts

Richard Saitz, MD, MPH
principal investigator · Boston Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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