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

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).

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:

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)