In an ongoing study of 1,000 U.S. athletes, coaches, and staff that recently traveled to Brazil for the Olympic Games, researchers are doing antibody testing to see if any acquired Zika virus. Those that show evidence of infection have agreed to long-term follow-up to determine if Zika persists in body fluids.
According to the study protocol by researchers at the University of Utah in Salt Lake City, a web-based reproductive health survey will be conducted eight weeks after travel to Brazil and follow-up will continue for at least one year to assess for pregnancy in female travelers and in the female partners of male subjects. Those who have identified pregnancies will be surveyed quarterly through pregnancy completion or termination to ascertain fetal/infant outcomes.
PCR testing will be done for blood, saliva, urine, semen, vaginal secretions, and breast milk. Comparative research will be done for those reporting symptomatic Zika infection versus asymptomatic, the latter of which occurs in about 80% of people who acquire the emerging virus. In addition, the researchers will compare reproductive outcomes in those with symptomatic versus asymptomatic Zika infection, including the ability to achieve and sustain pregnancy to term.
Carrie L. Byington, MD, professor of pediatrics and co-director of the university’s Center for Clinical and Translational Science, is the lead researcher for the study. She fielded the following questions for IRB Advisor:
IRB Advisor: What assurances did you provide your IRB regarding the confidentiality of the data gathered, and what steps were taken to ensure there was no suggestion of coercion to participate?
Byington: The study is de-identified, so participants will not be identifiable. All data are stored in a HIPAA- and FISMA-compliant database. All data will be reported in aggregate and no specific participant will be identified. All samples are labeled with a code and will thus be anonymous in the testing laboratories. No data will be entered into the electronic health record of the University of Utah. The study is voluntary and there is no penalty for those who choose not to participate. Potential participants received information about the study and have the opportunity to speak with study personnel to have all questions answered. There is no compensation. The U.S. Olympic Committee did not mandate participation.
IRB Advisor: Can you tell us a little more about the testing and follow-up aspects of this study?
Byington: We are testing antibodies in all 1,000 participants, so we will be able to identify Zika virus infection in both symptomatic and asymptomatic individuals. For those who test positive for Zika virus, we will test body fluids monthly until clear. We anticipate testing most individuals for up to six months, but are able to extend this testing window to 24 months if needed. We are interested in following any pregnancies that might occur in Zika-exposed participants, as we believe the extent of Zika virus infection in infants has not been fully described.
IRB Advisor: Since elite athletes are in peak physical condition, is it possible their physiology could introduce a variable that makes the results harder to extrapolate to general populations?
Byington: It is possible that elite athletes might have different physiologies; however, we are enrolling athletes, coaches, and other staff. Our athletes include Olympians and Paralympians. There is a wide range of ages and physical conditions represented that will allow the findings to be more generalizable. We believe all participants are at similar risk for Zika exposure and most will be naive to Zika prior to travel.