HIV Infection Clinical Trial
Official title:
Addressing Alcohol/HIV Consequences in Substance Dependence - Boston ARCH Cohort
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | August 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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) | Between study entry and final visit (minimum of 12 months) | No |
Primary | 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) | No |
Secondary | 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 | Between study entry and final visit (minimum of 12 months) | No |
Secondary | 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) | Between study entry and final visit (minimum of 12 months) | No |
Secondary | 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) | Between study entry and final visit (minimum of 12 months) | No |
Secondary | 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) | Between study entry and final visit (minimum of 12 months) | No |
Secondary | 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. | 12 months prior to study entry through final visit | No |
Secondary | 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) | Between study entry and final visit (minimum of 12 months) | No |
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