Clinical Sciences Core (C) : Services


Biostatistical Services

  • Study design
  • Power calculation/sample size
  • Data analysis plan
  • Data analysis
  • Abstract, manuscript assistance and collaboration

Clinical Services

  • Study design/protocol development
  • Subject recruitment, screen, consenting
  • Clinical assessment
  • Clinical research pharmacy
  • Facility/equipment access
  • For pilot studies/CFAR development studies, subject identification, recruitment, consent and supported intervention capability
  • HIV testing (rapid test)
  • Provision of research pharmacy services for interventional studies

  • Clinical Specimen services*
  • Identification/collection of fresh clinical samples (whole blood, plasma, sera) for well characterized HIV subject population, including HIV viremic and aviremic
  • Identification/collection of fresh clinical samples (whole blood, plasma, sera) for well characterized HIV negative controls
  • Access to stored samples (plasma, sera, PBMCs) from well characterized longitudinal cohort, limited to study design need of longitudinal sampling
  • Limited mucosal samples ( rectal, cervicovaginal) from clinically well characterized HIV subjects and HIV negative controls

Study development and consultative services

  • Assistance with clinical study design and development
  • Assistance with investigator initiated studies, pilot studies, CFARDevelopmental study with subject identification and recruitment, research nursing assistance, phlebotomy, limited tissue collection, data management and research pharmacy services
  • Access to state-of-the-art clinical research facility for pilot studies, CFARDevelopmental awards, NIH studies and industry studies
  • Access to expertise in the development and implementation of vaccine trials
  • IRB submission guidance

Data services

Mining of HIV Care & Treatment Data Repository
Upon IRB approval, data queries and data sets are available for a limited number of variables collected from patients receiving care and treatment in the University of Miami/Jackson Memorial Hospital Special Immunology Adult and Women’s Clinics.

Data can be extracted for:

  • Feasibility Studies
  • Data matching to supplement study cohort with data with additional variables
  • Additional patient data to supplement existing study cohort

Data Available (examples):

  • Demographical Data (basic)
  • HIV Disease Profile (Date of Diagnosis, HIV/AIDS Status)
  • Socioeconomic status, Primary Insurance, and Federal Poverty Level
  • Anti-retroviral Regimen
  • Laboratory Results:
    o Immunological/HIV Status (CD4, Viral Load)
    o Sexually Transmitted Infections Results
    o Hepatitis Screening
  • Visit History (clinic visits)