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Distinguished Staff Award

Distinguished Staff Award

Partners PrEP Study Team

Lead nomination by: Connie Celum, Professor Global Health & Medicine, Director International Clinical Research Center, Global Health

Partners PrEP Study Team

Members of the Partners PrEP Study Team are Mira Emmanuel-Ogier, Harald Haugen, Ting Hong, Lara Kidoguchi, Meighan Krows, Susan Morrison, Dana Panteleeff and Kathy Thomas.

The eight staff members detailed below are the core operations and analytical team implementing the Partners PrEP Study, for which we are the lead investigators. The Partners PrEP Study was a randomized, placebo-controlled, HIV prevention clinical trial, involving 4758 heterosexual HIV serodiscordant couples (i.e., one partner was HIV-infected and the other HIV-uninfected) from nine clinical research sites in Kenya and Uganda. The trial was testing a new HIV prevention strategy called pre-exposure prophylaxis (PrEP) in which an HIV-uninfected person at high risk for acquiring HIV took a daily antiretroviral (anti-HIV) medication as prophylaxis against acquiring infection. Two medications were tested in the Partners PrEP Study: tenofovir and tenofovir in combination with emtricitabine. Like other prevention strategies—prophylaxis against malaria in travelers, cholesterol medications to prevent heart disease—PrEP was delivered in combination with other key HIV prevention interventions (HIV testing, risk reduction counseling, and condoms).

In July 2011, the independent Data and Safety Monitoring Board of the Partners PrEP Study recommended early stoppage of the trial’s placebo arm due to unequivocal efficacy of PrEP for HIV prevention. The two PrEP medications reduced the risk of HIV acquisition in study participants by 67-75%; protection was ~90% among participants who had consistent adherence to PrEP. The results of the Partners PrEP Study have been widely described by leading scientists, the World Health Organization, the US National Institutes of Health, the US Centers for Disease Control and Prevention, media, and others as a key milestone in the global fight against HIV. In July 2012, the US Food and Drug Administration approved combination tenofovir/emtricitabine as the first medication ever indicated for the prevention of HIV. The FDA approval was widely heralded as an HIV prevention breakthrough - lead headline in the Seattle Times, one of the key scientific milestones of the past year by Time magazine, front-page coverage in national newspapers, and on the University of Washington’s website. The results of the trial were published this past July in The New England Journal of Medicine (and the staff members listed below were co-authors).

The Partners PrEP Study was funded by a research grant to University of Washington from the Bill and Melinda Gates Foundation. The study medications were donated by Gilead Sciences, a pharmaceutical company based in California, but the company had no financial contribution otherwise to the trial and did not oversee the protocol or its execution. Thus, the trial was completely coordinated by this team, based in the Department of Global Health. The application to the US Food and Drug Administration was through an Investigational New Drug application held by the University of Washington and all project coordination, from start up, site development and training, through on-site Food and Drug Administration audits in May 2012 to final submitted analyses, were overseen by this team. While the Partners PrEP Study has been ongoing since 2007, the major accomplishment of the study - analysis of results, manuscript preparation, site audit preparedness, and presentation of data to the US Food and Drug Administration - were accomplished during this past year.

Dana Panteleeff, Manager of Research Operations: Dana led the operations team, overseeing study implementation with daily troubleshooting of issues that arise 10,000 miles away. Dana personally assisted the US Food and Drug Administration with site audits - no issues were identified by the auditors, an almost-unheard of outcome.

Meighan Krows, Clinical Trials Coordinator: Meighan was our critical link to the African sites and provided daily email and phone contact to sites about how to navigate the many unexpected challenges. Her weekly priority emails gave the sites a framework to prioritize issues, and her near-daily 6 AM calls helped troubleshoot issues.

Mira Emmanuel-Ogier, Research Operations Coordinator: Mira provided essential regulatory oversight and Communication— e.g., more than 16 institutional review boards providing ethical reviews. She was the key link between the University of Washington investigators, Gilead Sciences, and the US Food and Drug Administration. She trained and prepared the sites for the audits. Finally, she oversaw >300,000 bottles of study medication from shipping through importation to dispensation.

Susan Morrison, MD, Clinical Safety Physician: Susan reviewed >22,000 adverse events over the course of the study. Her outstanding oversight of clinical and laboratory adverse events gave the entire team confidence in the monitoring of the safety of participants during the trial.

Harald Haugen, Laboratory and Repository Manager: Harald oversaw all the laboratory procedures for the study including labeling, quality assurance of laboratory assays for the study, processing, archiving and shipping of over 1.5 million samples to the University of Washington biorepository.

Katherine Thomas, Statistician, Data and Analysis Team Manager: Kathy oversaw the primary study analyses, covering more than 100,000 participant visits during the study. The quality of the data and clarity of the analyses for this study were widely praised. In addition, Kathy was the key back-up during formal presentation of the results to the US Food and Drug Administration.

Lara Kidoguchi, Data Manager: Lara performed a key function in distilling key data into clear reports for the sites and extensive open and closed reports for the independent Data and Safety Monitoring Board and the US Food and Drug Administration. Real-time, easily interpretable reports are key to monitoring progress and responding to issues in trials, and the Partners PrEP Study reports Lara created were invaluable to the study’s success.

Ting Hong, Statistician: Ting completed key safety analyses as part of the US Food and Drug Administration application. With Katherine Thomas and Lara Kidoguchi, Ting worked near-continuously from August 2011 until May 2012 to complete the US Food and Drug Administration application for this study.

In summary, this extraordinary team of University of Washington staff collectively accomplished what few research groups have ever done. They achieved extremely high recruitment, retention, data quality and overall study quality in a large and highly complex HIV prevention trial in Africa, and they shepherded a new product for HIV prevention through regulatory approval, all while based in here at the University of Washington. Their accomplishments have truly set a new standard for HIV prevention trials, and put the University of Washington on the headlines of national and international news. They did this with grace, humor, tireless efforts, and a strong team spirit. They inspired and guided our African teams, and built genuine partnerships. Thirty years into the HIV pandemic, they enabled us to identify a novel, highly effective HIV prevention intervention that will make a substantial impact on HIV prevention globally. This team is most deserving of the University of Washington Distinguished Staff Award, as examples of what commitment, tenacity, and resourcefulness can achieve.