February 27, 2023

Dr. Diane Harper tapped to lead NCI clinical trial site

Prof. Harper will contribute to a significant national study assessing the validity of at-home HPV self-testing as an alternative to speculum-based screenings in the fight against cervical cancer. 

Professor Diane Harper, MD, MPH, MS, of the Department of Family Medicine, Obstetrics & Gynecology, Women's and Gender Studies, and Biomedical Engineering at the University of Michigan, will partner with NCI to bring the Last Mile Initiative to the Michigan-based clinical sites. The initiative is part of the ongoing “Self-sampling for HPV testing to Improve Cervical Cancer Prevention” (or SHIP) trial.

Diane Harper, MD
Professor Diane Harper, MD, MPH, MS

Despite the availability of highly sensitive screening approaches such as primary HPV testing, over 13,000 women continue to be diagnosed with cervical cancer annually in the United States, according to the NCI. Research has shown that because of the discomfort women experience during speculum-based screenings, women often delay being tested for cervical cancer until they are experiencing symptoms. Additional barriers to preventative screening include socioeconomic disparities and geographic inaccessibility. For patients for whom speculum-based screenings are not ideal, the at-home HPV self-test is an attractive alternative and clinicians are increasingly using the new technology to screen for cervical cancer. However, more research is needed to determine if the self-test is indeed a reliable alternative to speculum screenings, which are currently considered the gold standard. 

In direct response, the NCI created the Cervical Cancer ‘Last Mile’ Initiative to accelerate progress towards regulatory approvals for HPV self-tests and facilitate the adoption of self-sampling based HPV testing for primary cervical cancer screening. The initiative represents a partnership between federal agencies, industry partners and professional societies.

One important component of this effort is the SHIP trial, which will provide important evidence to help drive forward policy efforts around cervical cancer prevention. The SHIP trial seeks to evaluate the accuracy of self-sampling testing for HPV in diverse delivery settings. The research effort will leverage a multi-center network of clinical enrollment sites across the U.S. to enroll a diverse participant pool in the study, one of which will be led by Harper and her team at the University of Michigan.

“As part of the University of Michigan, I am honored to work with the NCI to help develop and conduct this critical clinical trial, which has the potential to make it easier and more convenient for individuals to test for HPV in the comfort of their homes,” Harper said.

As a clinical enrollment site, Harper and her team will work in close partnership with the NCI’s Last Mile team and community partners to recruit study participants. Harper has already done significant self-sampling studies in the surrounding communities, including in partnership with ACCESS in Dearborn, Friends of Parkside in urban Detroit, and rural Mid-Michigan under-screened women. Expanding to collaborate with the NCI amplifies her efforts for FDA approval and eventual universal self-sampling for cervical cancer screening among average risk women.  

“I thank these community partners who have helped move this clinical trial forward,” Harper said. “It’s important that we make it as easy as possible for individuals to be screened in an environment most comfortable to them. We are eager to begin our involvement in these clinical trial efforts.”