Research Projects


Statistical Methods for Combination HIV Prevention Approaches

R01 MH105857 (PI: Chen)
This application proposes statistical methods development for HIV combination prevention approaches. The proposed development aims to provide a set of useful tools for design, analysis and implementation of HIV combination prevention approaches. Its translational value lies in that these tools shall greatly facilitate the search and the assessment of optimal HIV combination prevention approaches to achieve maximal benefit in HIV prevention.

Statistical Methods for Adherence Issues in HIV Prevention

R01 AI121259 (PI: Chen)
This application aims to develop new statistical tools and software to measure, assess and analyze longitudinal adherence patterns in HIV prevention research. Its overall public health impact lies in applying these new tools to improve our understanding of the health implications of adherence in translational research and clinical care.

Predicting PrEP Uptake and Adherence among Adolescent Girls and Young Women in Sub-Saharan Africa: Leveraging Programmatic and Clinical Trials Data

R01 HD094682 (PI:Chen)
Adolescent girls and young women experience among the highest rates of HIV infection in the world. This project uses data from HIV-prevention programs and clinical trials, as well as mathematical modeling, to study how best to combine different prevention approaches to achieve maximum benefit for this population.

Methods for Complex Longitudinal Data in HIV/AIDS Prevention Research

R01 AI029168 (PI: Chen)
07/01/2018 - 06/30/2019
This application aims to develop a set of new statistical tools and software to analyze complex longitudinal data generated in HIV prevention research. These new tools will be used to improve our understanding of the health implications of longitudinal outcomes, such as drug adherence, in HIV translational research and clinical care.

Risk Factors and Association of CMV Reactivation with Clinical Outcomes in ICU Patients

Merck Sharp and Dohme Corp. (PI: Limaye)
This project will characterize the specific CMV reactivation parameters associated with key clinical outcomes for a future phase 3 study. As well as allow investigators to identify specific baseline risk factors that are predictive of the CMV reactivation parameters linked with key clinical outcomes.

Statistical Issues in AIDS Research

R56AI140953 (PI: Hughes)
This project addresses important issues in the statistical analysis of data from trials of interventions of treatment and prevention of HIV infection by extending the work scope to the exploration of design and analysis issues arising in field trials of vaccines for prevention of HIV infection.

Statistical Data and Management Center for HIV/AIDS Prevention Trials Network

UM1 A1068617 (PI: Donnell)
This application to be the Statistical and Data Management Center (SDMC) describes how the Statistical Center for HIV/AIDS Research & Prevention (SCHARP) will (1) provide leadership for the design, conduct, analysis and publication of Network clinical trials/studies; (2) provide central data management capability that includes randomization, data set and case report form design, central storage, security, processing and retrieval of study results; (3) provide data management and protocol training throughout the Network; (4) provide data-focused clinical trials implementation and operation; and (5) contribute to cross-Network efforts in developing common data elements.

Modulating the Impact of Critical Events in Early HIV Infection: Effect of Early ART Initiation and Alcohol Use

R01 DA040532 (PI: Duerr)
The overall objective of this research project is to determine the influence of timing of ART initiation and alcohol consumption on HIV disease course, including detailed analysis of important events occurring shortly after HIV acquisition. The goals of the proposed specific aims are to: 1) determine the relative long-term benefits of immediate vs. early vs. delayed ART initiation; and 2) determine the impact of alcohol use on the relative long-term benefits of immediate vs. early vs. delayed initiation of ART.

HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women 

R01DA032106 (PI: Duerr)
This study looks at how HIV medicines (ART) when given very early after HIV infection affect the amount of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using modeling studies to look at whether or not this kind of HIV treatment can decrease the risk that a man will infect a person he has sex with and to find out how failure to take medications will impact spreading the virus to other people.


Methods for Time-Varying Disease Attribution in Chronic Disease Prevention

R01 CA172415 (PI: Chen)
09/30/2013-07/31/2018 (NCE)
The objective of this methods project is to develop and apply new statistical methods to improve scientific inferences on the disease attribution associated with risk factors, such as obesity and tobacco smoking, for data collected from longitudinal cohort studies in chronic disease prevention research.

Sunovion Statistical Data Analysis Center for Pediatric Clinical Trials Program

PI: Chen
The Sunovion Statistical Data Analysis Center is the independent Statistical Analysis Center for the independent Data Safety Monitoring Board for the Lurasidone pediatric clinical trials sponsored by Sunovion.

DAS181 for Treatment of Parainfluenavirus Disease in Immunocompromised Patients

(PI: Boeckh)

Currently, there are no specific treatments for parainfluenza. However, a drug called DAS181 may make the virus go away faster. Researchers are interested in testing DAS181 to see if it is safe and effective against parainfluenza.

A Randomized Double-Blind Placebo-Controlled Trial of Ganciclovir/Valganciclovir for Prevention of Cytomegalovirus Reactivation in Acute Injury of the Lung and Respiratory Failure: The GRAIL Study

(PI: Boeckh)

The role of cytomegalovirus (CMV) reactivation in mediating adverse clinical outcomes in nonimmunosuppressed adults with critical illness is unknown. This research aimed to determine whether ganciclovir prophylaxis reduces plasma interleukin 6 (IL-6) levels in CMV-seropositive adults who are critically ill.