Emerging Infections and Treatment in Pregnancy EI-TIP
Funded by CDC, EI-TIP addresses one of CDC's research priorities within its program Applied Research to address Public Health Priorities: to address critical knowledge gaps related to emerging and re-emerging infectious disease during pregnancy and the risk, benefits and acceptance of prevention and treatment strategies.
Specific aims
Emerging infections have significant effects on public health, especially in vulnerable populations like pregnant women. With increasing prevalence of hepatitis C and risk for perinatal transmission, recent recommendations include universal HCV screening during pregnancy. To what extent these recommendations have been implemented, and whether diagnosis results in expeditious maternal treatment and follow-up among infants is unclear.
Also, pregnant women are vulnerable in the event of an intentional release of infectious agents. Doxycycline is used for a variety of common pathogens, and is recommended for postexposure prophylaxis for bacillus anthracis and yersinia pestis. Although doxycycline has been on the market for decades, safety data on fetal risk and long-term effects in infants are incomplete.
The EI-TIP study will employ comprehensive databases of linked mother and baby cohorts enhanced with additional multiple data that capture patient, provider and community-level characteristics to study two focus areas, each with multiple aims:
- Impact of recommendations for universal HCV screening during pregnancy, andÂ
- Safety of prenatal exposure to doxycycline and fetal and infant outcomes
Special features
EI-TIP takes advantage of extensive research infrastructure that can be used to examine the intersection of emerging infections and therapeutics to guide efforts to mitigate adverse maternal, fetal, and infant outcomes. While building on long-established pharmacoepidemiological principles, we introduce an innovative analytical data mining component in our analysis of doxycycline safety to optimize our ability to detect signals that may warrant formal follow-up. We also optimize the utility of our claims-based mother-baby cohorts, offering the opportunity for longitudinal follow-up of one of the largest cohorts of pregnancies, via targeted linkages to other data to enhance the validity and breadth of measures.
Study team
EI-TIP is a collaboration of researchers at the University of Florida, Johns Hopkins University, Harvard and the Centers for Disease Control and Prevention (CDC). Funded by CDC, EI-TIP addresses one of CDC’s research priorities, which aims to address critical knowledge gaps related to emerging and re-emerging infectious disease during pregnancy and the risk, benefits and acceptance of prevention and treatment strategies. Our team combines experts in epidemiology, Pharmacoepidemiology, genetics, child and maternal health, data mining and signal detection, and infectious disease.
Principal investigator
Almut G Winterstein, RPh, PhD, FISPE, ASEMFL
Distinguished Professor in Pharmaceutical Outcomes & Policy, Director Center for Drug Evaluation & Safety, University of Florida
Co-Principal investigator
Sonja A Rasmussen, MD, MS
Professor of Genetic Medicine, Johns Hopkins Medicine
Co-investigator
Judith Maro, MS, PhD
Assistant Professor on Population Medicine, Harvard Medical School
co-investigator
Thuy Thai, BSPharm, MS, PhD
Assistant Scientist, Pharmaceutical Outcomes & Policy, University of Florida
Post-doctoral fellow
Jerry Idigo, BSPharm, MPH, PhD
Post-doctoral Fellow, Pharmaceutical Outcomes & Policy, University of Florida
Data analyst
Carl Henriksen, MS
Data Management Analyst, Pharmaceutical Outcomes & Policy, University of Florida
reserach assistant
Nicole Smolinski, PharmD
Graduate student, Pharmaceutical Outcomes & Policy, University of Florida
research assistant
Celeste Ewig, PharmD
Graduate student, Pharmaceutical Outcomes & Policy, University of Florida
research assistant
Matthew Muschett, PharmD
Graduate student, Pharmaceutical Outcomes & Policy, University of Florida
research assistant
Priyanka Kulkarni, BSPharm, MS
Graduate student, Pharmaceutical Outcomes & Policy, University of Florida
research assistant
Hung-Kai (Henry) Chen
Graduate student, Pharmaceutical Outcomes & Policy, University of Florida
visiting scholar
Junko NAGAI, PhD
Visiting scholar, Pharmaceutical Outcomes & Policy, University of Florida