The Biometrics Core provides a central resource of biostatistical expertise to improve the conception, design, and analysis of HIV/AIDS studies.
Any CFAR investigator can consult with Core biostatisticians and quantitative scientists for assistance with study planning and design for grant applications (eg, sample size and power calculations, development of analytical plans), study implementation (eg, data management, statistical analysis), or research communication (eg, drafting of abstracts, posters, or articles).
In addition to collaborating on specific projects with basic, clinical, and scientific researchers, the Core offers training and education in quantitative methods for all CFAR investigators and also provides a multidisciplinary forum for discussion of ideas, trends, and problem-solving tips related to advanced quantitative methods.
We have found that it is most useful to collaborate with investigators as early as possible during a project, for example even before study aims are finalized. Therefore, we encourage you to submit a Request For Consultation, which will be used to help coordinate biostatistical and other quantitative support for manuscripts, abstracts, and meeting presentations.
The training and mentoring of CFAR investigators, especially those early in their careers, is an important goal of the CFAR Biometrics Core. Through partnerships with other UW/Fred Hutch CFAR groups, we not only provide services directly but also build capacity so that study team personnel can take on many future tasks independently.
The Viral Dynamics Primer is intended to introduce the concepts of viral dynamics to researchers who are conducting studies of this type, are analyzing data from studies of this type, or who would like to learn more about research in this area. No experience in mathematics or statistics is assumed.
The Biometrics Core is collaborating on a range of research projects involving the prevention, pathogenesis, or treatment of HIV/AIDS. Examples include:
Mathematical Modeling of Viral Dynamics and/or Viral Set Point
- Examination of dynamics of viral RNA and DNA in the female genital tract after the start of therapy, and analysis of viral load trajectories in relation to survival outcomes using functional data analytic techniques
- Analysis of patterns of viral RNA and DNA in breast milk of HIV-1 infected mothers
- Exploration of the viral dynamics of HIV/Hepatitis C co-infection
Investigating interactions between the human genital microbiome, syndromes, and pathogens
- Data management and statistical analysis in support of the STI Cooperative Research Center projects and other investigator-driven research cohorts, including examination of HIV, HSV shedding, BV, and urethritis. Methods include Principal coordinates analysis, hierarchical clustering, and other methods relevant to community-level compositional data
Development of cluster and stepped-wedge study designs
- The core has collaborations with Dr Jim Hughes, the Implementation Science Core, and other investigators to develop innovative and cost-efficient studies implemented at the facility level
Seattle Primary Infection Project (SeaPIP) and studies of acute/early infection
- Management of project database and statistical analysis for the Seattle Primary Infection Program. Recent research has focused on timing in Fiebig stages (utilizing an E-M algorithm for chain of events data with interval censoring), assessing prevalence and correlates of post-ARV treatment control, and assessing transmission of drug resistance within partner pairs
Targeted Long-acting Combination Antiretroviral Therapy (TLC-ART)
- Analytical and database support to this multidisciplinary group developing products using nanoparticle technology, that could lead to increases in drug levels in lymph tissue and allow for less frequent administration and enhanced adherence. Areas of research include PK/PD/PB modeling, and conjoint analysis of target population preferences
Studies of child health and development
- Recent collaborations have explored strategies for the treatment of HIV in young children to minimize the incidence of adverse IRIS, drug toxicity, and neurocognitive delays.
Viral Sequences and Viral Reservoirs
- Search for potential HIV-1 compartmentalization within the female genital tract, and analysis of HIV-1 genotypes from the uterus, cervix, and blood to clarify dynamics and spread of HIV-1 within the body
Identifying Predictors of Viral Genital/Rectal Shedding During Antiretroviral Treament
- Statistical analysis of data from phylogenetic trees, with permutation-based methods, to explore mechanisms associated with discordant shedding (and likely higher risk of transmission) of HIV-1 from the genital tract and rectum
In addition to research collaborations, the Biometrics Core engages in educational and institutional activities to support multidisciplinary research within the CFAR. These include:
CFAR Award Programs
Each year, Dr Holte provides statistical consultations to various CFAR award programs, including the CFAR Developmental Core New Investigator Awards (NIA) and HIV-Associated Malignancy Research Pilot Awards.
Sarah Holte, PhD
Biomathematician/statistician, Core Director
sholte at fredhutch.org
Barbra Richardson, PhD
Biostatistician, Associate Director
barbrar at uw.edu
Elizabeth Brown, ScD
Biostatistician, Associate Director
erbrown at fredhutch.org
Ken Tapia, MS
Biostatistician, Core Manager
ktapia at uw.edu
Joshua Stern, MS
jstern77 at uw.edu
Lei Wang, MS
lwang7 at uw.edu
Pirie Hart, PhD, MBA
Senior Computer Specialist
pirie at uw.edu
Core Steering Committee: Ann Collier, MD; Robert Coombs, PhD; Thomas Fleming, PhD; Jim Hughes, PhD; Lisa Manhart, MPH, PhD; Scott McClelland, MPH, MD; Jennifer Slyker, PhD