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

NCT01740115 | Completed DMC

• 1 other identifier: U01AA020784
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

HIV; Alcohol Use; Bone Disease; Bone Mineral Density; Bone Microarchitecture; Substance Dependence

Outcome Measures

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)

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

Secondary Outcomes (6)

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

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

• Proportion with bone mineral density decrease of >6%

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

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

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

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

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

• Fractures (vertebral, hip, wrist)

  12 months prior to study entry through final visit

Other Outcomes (1)

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We are storing serum and plasma for future use. We are also storing dried blood spots.

MeSH Terms

Conditions

HIV Infections; Alcohol Drinking; Bone Diseases; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Drinking Behavior; Behavior; Musculoskeletal Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Richard Saitz, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Community Health Sciences, Professor of Community Health Sciences and Medicine, Boston University Schools of Medicine and Public Health

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Locations

US (1)