Issue link: https://viewer.e-digitaledition.com/i/1361647
THE ANATOMY OF A STUDY For her clinical trial conducted from 2014 to 2016, Dr. Winer enrolled 19,851 women ages 30 to 64 who were not in compliance with guideline-recommended intervals for cervical cancer screening, meaning they had never been screened or were overdue for a screening. Specifically, the women in the trial had not been screened for more than 41 months. Guidelines recommend having a Pap test every three years or a Pap test and HPV test together every five years. A control group was notified about screenings through annual reminders and outreach from primary care clinics. The interven- tion group received these communications and was also mailed an HPV self-sampling package. The research team's primary outcomes were detection of CIN2+ within six months of screening and treatment within six months of CIN2+ detection. A secondary outcome was screening uptake within six months of randomization. THE RESULTS Dr. Winer and her fellow researchers found that by mailing home-based HPV screening kits to women in the United States healthcare system who were underscreened, they could increase cervical cancer screening by 50% in comparison with sending standard reminder communications related to Pap screening. However, they did not notice a statistically significant change in the detection or treatment of cervical precancers. "When we designed the trial, we thought that the increase in screening with mailed HPV kits would be even higher than we observed," Dr. Winer says. "This is one reason why we think there was not a significant increase in detection of precancers in the intervention group versus the control group. Cervical precancers are not very common, so we would have needed a larger difference in screening between the two groups in order to see a statisti- cally significant difference in the number of precancers detected." Another reason that the research team did not find a statistica lly significant increase in precancer detection between the different randomization groups is that only some of the women who had positive HPV kit results participated in the recom- mended follow-up testing. A number of these women may have had precancers that were not detected for this reason. "Our trial deployed several strategies to encourage appropriate follow-up of abnormal results, yet there was still a gap in follow-up adherence," Dr. Winer says. "Given the complex and dynamic nature of U.S. cervical cancer screening guidelines, healthcare systems may need to devote additional resources to support screening, diagnostic and treatment completion when implementing new strategies such as home-based HPV self-sampling." n " Now that primary HPV screening is a guideline-approved screening strategy in the U.S., there is a real possibility for home-based HPV screening to become a widespread option for women." — RACHEL WINER, PHD, PROFESSOR OF EPIDEMIOLOGY WITH THE UNIVERSITY OF WASHINGTON DEPARTMENT OF EPIDEMIOLOGY AND AFFILIATE INVESTIGATOR AT KAISER PERMANENTE WASHINGTON HEALTH RESEARCH INSTITUTE M D N E W S . C O M /// M D N E W S L O N G I S L A N D ■ 2 0 21 2 5

