U.S. health experts want to test a different way for women to fight cervical cancer from the comfort of their homes and bring the country closer to eradicating a disease that kills more than 4,000 Americans every year.
First, use a tiny brush to briefly clean the vagina and collect cells. Then slide the swab into a sorting kit and drop it into the mail.
The National Cancer Institute plans to launch a multisite study next year involving about 5,000 women to assess whether a simple test at home like this is comparable to screening in the office by a doctor.
About 14,000 women in the U.S. will be diagnosed with highly preventable cancer this year, and those who don’t have insurance or can’t receive regular medical care are more likely to miss life-saving screening, he said Vikrant Sahasrabuddhe, director of the program in the Cancer Prevention Division of NCI. If women could collect the vaginal and cervical cells to be tested for human papillomavirus, or HPV — the virus that causes virtually all cervical cancers —they can be examined from home, just as samples of homemade feces can be used to detect colon cancer, he said.
“What we’ve seen is this persistent group of women who continue to have cervical cancer every year,” said Sahasrabuddhe, who oversees studies involving studies involving studies involving studies HPV-related cancers. “And that number really won’t drop.”
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Federal officials expect the research to accelerate a test approved by the Food and Drug Administration that could be part of screening guidelines if self-sampling proves effective, Sahasrabuddhe said.
Instead of waiting for self-sampling studies to be done by companies that test for HPV, federal employees will join companies, academic institutions, and others in public-private partnerships. NCI researchers, who expect to spend about $6 million in federal funds, will oversee the study’s data and analysis.
“If each company goes and does its own test, it can take years to achieve it,” Sahasrabuddhe said. “We want to speed up this process.”
Hpv self-sampling, already promoted in countries such as Australia and the Netherlands, is one of several approaches that U.S. health authorities are pursuing. Another is vaccinate adolescents against HPV, which is transmitted through sexual activity.
As of 2018, almost 54% of girls had been fully vaccinated at age 17, as well as nearly 49% of boys, according to the most recent federal data. The countries that have had the best success in reducing cervical cancer – an analysis of predicts that Australia is on track to eliminate the disease — emphasized HPV vaccination for adolescents.
Federal authorities also advise vaccinated women to be examined regularly, as the vaccine does not protect against all HPV strains that can cause cervical cancer. But convincing women to come to the office for physical examination can be hard to sell.
For some, access or cost can be a problem. Most insurance plans cover screening, and there are some public programs Available. But uninsured women who are unaware of them may have to pay for a visit and office test.
In addition, women may not always separate from work or find childcare, or they may have had “negative emotions or past experiences with pelvic exams,” he said Rachel Winer, professor of epidemiology at the University of Washington School of Public Health who studies HPV self-sampling.
About 4 in 5 women are regularly screened for cervical cancer, but rates have peaked around 2000 and have been at a slight decline since, according to federal data. This number, which is based on the patient’s self-report, can be optimistic. Another analysis, which looked at the medical records of 27,418 Minnesota women aged 30 to 65, found that almost 65% were up to date from 2016, according to a report published last year in the Journal of Women’s Health.
“Unfortunately, I think our data probably reflect more what’s going on with screening rates in our country,” he said Dr. Kathy MacLaughlin, author of the study and researcher at the Mayo Clinic in Rochester, Minn.
One obstacle to be examined may be the complexity of the guidelines, MacLaughlin said. Instead of an easy-to-remember annual exam, screenings occur at intervals of more than a year. A woman’s age helps determine when the HPV test or a Pap smear, which collects cells from the cervix to look for precancerous changes, is recommended by the U.S. Preventive Services Task Force.
“Is it just this challenge of, how does any of us remember doing something every three years or every five years?” MacLaughlin said. “That’s hard.”
Although NCI has not yet established itself on the precise self-sampling approach it will use, the technique usually requires the woman to insert a tiny brush into her vagina and rotate it several times to collect the cells. She then slides the brush into a specimen container that has a preservative solution and returns the kit for HPV analysis.
According to a review of studies published in 2018 in the medical journal BMJ, the accuracy of HPV identification was similar when samples were collected by women at home as when collected by physicians.
A urine-based HPV test, which may be easier for women to perform, is also being studied, said Jennifer Smith,[11″, professor of epidemiology at the Gillings School of Global Public Health at the University of North Carolina.
Before companies can seek applications for an FDA-approved home test, the effectiveness of self-sampling to detect HPV should be comparable to standard clinical testing, though it may not be as accurate as when a doctor is involved, Sahasrabuddhe said.
NCl officials are still finalizing the details of the study. But the plan is to invite four companies that already manufacture HPV tests to participate, Sahasrabuddhe said. Companies will pick up the tab for the cost of testing as well as future fees related to searching for license applications through the FDA, he said. Sahasrabuddhe expects the results of the study to be available by 2024, if not earlier.
Any woman who tests positive for HPV will be referred for procedures, possibly including a biopsy, to look for abnormal cells or cervical cancer, Sahasrabuddhe said.
If an FDA-approved home test is developed, it is crucial that uninsured women and others who do not have easy access to medical care are able to obtain these procedures, Smith said.
“You just don’t send random kits to people’s homes,” Smith said, “and it doesn’t guarantee that they have someone to talk to about the results and be able to be integrated into a tracking system.”
Huff writes to Kaiser Health news, a non-profit news service that covers health issues. It is an editorially independent program of the Kaiser Family Foundation and is not affiliated with Kaiser Permanente.