Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Cohort
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01740115 |
Recruitment Status
:
Completed
First Posted
: December 4, 2012
Last Update Posted
: September 12, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
HIV Infection Alcohol Use Bone Disease Substance-Related Disorders |
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).
Study Type : | Observational |
Actual Enrollment : | 250 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Addressing Alcohol/HIV Consequences in Substance Dependence - Boston ARCH Cohort |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | August 2016 |

- Annual mean percent change in hip (femoral neck) bone mineral density (g/cm2) [ Time Frame: Between study entry and final visit (minimum of 12 months) ]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)
- Annual mean percent change in spine (trabecular bone) bone mineral density (g/cm2) [ Time Frame: Between study entry and final visit (minimum of 12 months) ]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
- Proportion with bone mineral density decrease of >6% [ Time Frame: Between study entry and final visit (minimum of 12 months) ]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)
- Proportion with osteopenia (bone mineral density t score -1 to -2.5 SDs compared to a young adult reference population mean) [ Time Frame: Between study entry and final visit (minimum of 12 months) ]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)
- Proportion of osteoporosis (bone mineral density t score <-2.5 SDs compared to a young adult reference population mean) [ Time Frame: Between study entry and final visit (minimum of 12 months) ]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)
- Fractures (vertebral, hip, wrist) [ Time Frame: 12 months prior to study entry through final visit ]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.
- Annual mean percent change in bone mineral density (g/cm2) at site with lowest bone mineral density (spine [trabecular bone] or hip [femoral neck]) [ Time Frame: Between study entry and final visit (minimum of 12 months) ]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)
- Bone mineral density, bone mineral content, trabecular thickness, separation and number, volume fraction and cortical thickness [ Time Frame: Between study entry and final visit (minimum of 12 months) ]Exploratory outcomes will be assessed using HR-pQCT (wrist and ankle)
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
- Current (12-month) substance dependence, determined by using the Mini International Neuropsychiatric Interview (MINI) or ever injection drug use (IDU)
- Ability to speak English (fluency)
- At least one contact person who is likely to know whereabouts (to assist with follow-up)
Exclusion Criteria:
- Under age 18
- Pregnancy (confirmed by urine test)
- Plans to leave Boston area in <1 year
- Inability to consent or understand interview (determined by trained research assistant)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740115
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Richard Saitz, MD, MPH | Boston Medical Center |
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 |
ClinicalTrials.gov Identifier: | NCT01740115 History of Changes |
Other Study ID Numbers: |
U01AA020784 ( U.S. NIH Grant/Contract ) |
First Posted: | December 4, 2012 Key Record Dates |
Last Update Posted: | September 12, 2016 |
Last Verified: | September 2016 |
Keywords provided by Richard Saitz, Boston Medical Center:
HIV Alcohol Use Bone Disease |
Bone Mineral Density Bone Microarchitecture Substance Dependence |
Additional relevant MeSH terms:
HIV Infections Alcohol Drinking Substance-Related Disorders Bone Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Drinking Behavior Chemically-Induced Disorders Mental Disorders Musculoskeletal Diseases Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs |