The Administrative Core provides the administrative infrastructure and leadership to carry out the goals of TNC.

• Assistance with Financial and/or Grant Management

The Development Core provides awards of up to $30,000 for one year for pilot projects in the area of nutrition, metabolic abnormalities, and/or hepatitis and liver function disorders among HIV+ and/or HIV- drug using populations.

The Drug User Resources Core provides consultations, training and/or written protocols on issues related to the recruitment and retention of drug using populations for research studies.

Timothy Flanigan, MD
Miriam Hospital

Consultation Services

• Design of tracking protocols and databases for longitudinal studies
• Development of standardized instruments to assess sensitive behaviors (i.e. risk behaviors and adherence to meds) among drug users
• Computer-Assisted Self-Interview (ACASI) for assessing sensitive information
• Adherence and Directly Observed Therapy (DOT)
• Recruitment and retention activities

On-Site Training:

• Recruitment, assessment, and follow-up of substance-using cohorts

Forms/Materials:

• Informational brochures
• Recruitment tools
• Ongoing review of recruitment and retention activities

The Nutrition and Metabolism Core provides expert advice and resources on issues related to the nutritional and metabolic consequences of HIV infection in drug users. Services include consultations and training and/or written protocols on appropriate nutrition, metabolic and/or quality of life measures. This Core also includes expert advice on the effects of drug use with or without HIV infection on glucose metabolism and the endocrine system (previously Core E: The Endocrine Core).

Consultation Services:

• Protocol development using appropriate nutritional and metabolic measures. This includes study design, population considerations, frequency of follow-up measures, etc.
  
• Inclusion of clinical nutrition assessment parameters appropriate to the study design and population, including wasting, obesity, fat redistribution, vitamin deficiencies, and energy expenditure.
  
• Inclusion of immune function and metabolic assessment parameters appropriate to the study design and population, including glucose and insulin levels, lipid analyses (total cholesterol, triglycerides, LDL-C, HDL-C, Lipoprotein-A), and C-reactive protein assessment.

On-Site Training:

Body Composition Measurements

• Anthropometry
• Bioelectrical Impedence (BIA)
• Dual X-Ray Absorptiometry (DEXA)
• CT Scans of abdomen and thigh

Dietary Intake

• 24-hour recall instrument, specific to drug-using populations
• Nutrient analyses of dietary data

Physical Activity

• Physical activity/caloric expenditure assessment methods

Quality of Life

• Data collection instruments to assess quality of life issues

Forms/Materials

• Resting Energy Expenditure Protocol
• Anthropometry Protocol
• Bioelectrical Impedence (BIA) Protocol
• Dual X-Ray Absorptiometry (DEXA) Protocol
• CT Scans (abdomen and thigh) Protocol
• Dietary Assessment Protocols
• Physical Activity Assessment Protocols
• Quality of Life Instruments

Serum Assays

There will be a small charge for supplies (test kits) related to the following assays:

• Micronutrients: vitamin A, E, carotenoids, selenium, and zinc and measures of oxidative stress
• Antiretroviral Drug Levels: nucleosides, non-nucleosides, protease inhibitors
• Cytokine
• Leptin
• Adiponectin
• Glucose and Insulin
• Oral Glucose Tolerance Test

Specimen Archiving

Consultation Services:

• Study design, framing of hypotheses, defining appropriate exposures and outcomes, choosing the appropriate analytic models, determining key covariates, and database and questionnaire design
• Power and sample size calculations in the planning phase of studies and grants
• Design and management of centralized databases for all multi-site, Center-wide studies
• Data management and analysis for individual Center-supported studies
• Advice on combining and analyzing existing data across sites

Forms/Materials:

• Standardized data collection instruments and protocols to be used by Center-supported studies

Services:

• Development of ACASI systems
• Data analysis for CDAAR-related projects
• Power and sample size calculations for new CDAAR-related grants

The Hepatitis and Liver Function Core will provide centralized, standardized services to investigators studying facets of liver disease and hepatic function in drug users in studies of nutrition and metabolism. It will also be able to assist investigators who seek to integrate liver disease data into the data collected in the multiple populations through the links set up by this Center. The Hepatitis and Liver Function Core will also provide educational, training, and outreach through Core personnel.

Tamsin Knox, MD
Tufts University School of Medicine

Consultation Services

• Protocol development using appropriate hepatitis and liver function measures. This includes study design, population considerations, frequency of follow-up measures, etc.
• Inclusion of liver function and hepatitis serology assessment parameters appropriate to the study design and population, including fibrosis markers, interpretation of liver biopsies, pharmacokinetics of drug metabolism, metabolic consequences of liver disease, and screening for hepatocellular carcinoma.

Serum Assays:

• Measurements of hepatitis serology
  1. Hepatitis A, IgM and IgG.
  2. Hepatitis B surface antigen, surface antibody, core antibody.
  3. Hepatitis C antibod

• Measurements of chronic hepatitis viruses:
  1. Hepatitis B DNA
  2. Hepatitis C RNA
  3. Hepatitis C genotype

• Other hepatitis viruses:
  1. Hepatitis delta antigen and antibody
  2. Hepatitis E

• Fibrosis markers
  1. Fibrotest
  2. APRI and other measures including FIB-4

• Pathologic interpretation of liver biopsies
  1. Assessment of fibrosis and inflammation using known scales
  2. Central blind reads and coding of liver histologic specimens
  3. Assessment and grading of hepatic steatosis

• Pharmacokinetics of drug metabolism
  1. Drug levels of protease inhibitors and non-nucleoside reverse transcription inhibitors.
  2. Alpha-1 acid glycoprotein levels
  3. Pharmacokinetic studies of antiretroviral drugs
  4. Drug interaction studies between antiretroviral drugs and drugs of abuse
  5. Genotyping for SNPs that alter drug metabolism.

• Screening for hepatocellular carcinoma:
  1. Alpha-fetoprotein – if requested by investigator

Services

• Offer interpretation and assistance with assessing nutritional status in subjects with cirrhosis and/or ascites, determining insulin resistance and hyperlipidemia in chronic liver disease, and total and free testosterone and sex hormone binding globulin measurements.
• Provide emphasis on studies of primary prevention of hepatitis through screening, vaccination, and counseling.