FDA-approved cervical cancer self-test aims to improve accessibility

A Central Phoenix obstetrics and gynecology examination room. The clinic offers comprehensive women's health care, from nutritional counseling to surgery to sexual health. (Photo courtesy of Lauren DeYoung/Cronkite News)

PHOENIX – One Friday night in 1982, Dr. Gail Petersen Hock was cooking dinner for her family when she got a call from her obstetrician-gynecologist.

“He said, 'Sit down,'” she recalled. “He said, 'We have cancer in your cervix. You'll need surgery next week.'”

“It was a surprise to me,” she said.

Petersen-Hock, 69, was 27 when she was diagnosed with cervical cancer and her treatment lasted almost 20 years. She considered herself lucky.

“I had biopsies every six months until I was in my 40s,” she says, “and then I was treated with TCA (tricarboxylic acid), which is a very strong acid. I haven't had any problems since then, but I'm one of the lucky ones.”

Dr. Gail Petersen-Hock talks about her experiences as a cervical cancer survivor and advanced practice public health nurse. (Screenshot credit: Regan Gallo/Cronkite News)

Petersen-Hock is committed to using her experience to lower cervical cancer rates through education about testing and related vaccinations, and she co-leads the Arizona chapter of the National Cervical Cancer Coalition. She and other health care professionals hope that the new Food and Drug Administration-approved cervical self-test will make testing more accessible and lower cervical cancer rates.

On average, more than 200 women are diagnosed with cervical cancer each year in Arizona, according to data from the National Cancer Institute and the Centers for Disease Control and Prevention from 2016 to 2020. Nationally, the five-year survival rate for cervical cancer is 67%, according to NCI data.

But according to Dr. Sharon Thompson, CEO and chief physician at Central Phoenix Obstetrics and Gynecology, cervical cancer is preventable with proper screening.

“The warning signs of cervical cancer don't just appear out of nowhere,” she says. “Changes occur in the cervix before it becomes cancer, and if we can detect and treat those changes, we can prevent cervical cancer.”

Cervical cancer can be detected by a Pap smear or Human Papillomavirus (HPV) test, as most cervical cancers are caused by HPV infection. In these tests, a doctor uses a speculum to open the vaginal wall and a brush to take a sample of cells from the patient's cervix, a process that can be uncomfortable.

In a self-test, patients insert a swab or similar device into their vagina to collect cells, which are then taken at a clinic and the doctor sends the sample to a laboratory.

Dr. Sharon Thompson, CEO and primary care physician at Central Phoenix Obstetrics and Gynecology, believes cervical cancer self-exams can have a lasting impact on screening rates, as long as proper follow-up care is implemented. (Photo by Sharon Thompson)

“If you have access to your vagina, or if someone else has access to it, you can take a proper swab,” Thompson says. “We know that the sample we need can be taken from the entire vagina, so we don't need to take a specific spot.”

The technology is not new to health care providers like Dr. Caitlin Lee, director of medical quality and director of health equity at Wesley Community and Health Center.

“It's kind of an off-label use, but we've used it,” she said. “In fact, we just got the results back this morning from a cervical cancer screening test for a patient with a history of trauma who did a self-collected swab test in the clinic last week.”

After the test results are available, the doctor will contact the patient. If further testing is required, such as if abnormal samples are found, the doctor will explain what the follow-up care will be. However, whether patients receive proper follow-up care is a concern for some healthcare providers.

“What happens if they get a positive result,” Thompson said. “If these tests are for people who don't have access to medical care, what happens if they get an abnormal Pap test? Are they going to get the follow-up that they need?”

“We have a responsibility to those who need to be tested or return to care,” said Petersen Hock, who ran a Title X clinic in Phoenix and worked as an advanced practice public health nurse. “I can't tell you how many times I've written 'lost to follow-up' in a patient's chart. This is not an uncommon situation.”

At the Wesley Community & Health Centre clinic, cervical cancer self-examination will be successfully integrated into the current follow-up system.

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“We already have programs in place to ensure that patients who have abnormal cervical cancer screens are followed up and receive the appropriate diagnostic tests and treatments, if necessary,” Lee said. “Other primary care clinics may not be doing as many tests and are accustomed to referring these to specialty clinics, so they may need to make some adjustments to their workflow.”

Even with self-testing, barriers to receiving care still exist: current guidelines require patients to make an appointment at a clinic to self-test, which can limit access.

“You still have to get to the doctor's office, and to do that you have to be able to get them in the door,” Lee said.

“You'll need to make an appointment,” Petersen-Hock added, “you'll need to travel to the clinic, you'll need to have childcare if you have children, and you'll need to be prepared to undergo cancer-related tests.”

Barriers to getting tested include cost, clinic location, insurance status, education level, and comfort level in the clinical setting. People with a history of trauma, especially sexual trauma, may be hesitant to get screened for cervical cancer because of the invasiveness of the Pap test. Healthcare providers hope that self-testing can help break down some of the barriers to care for underserved populations.

“I always hope that if we have a test that offers fewer requirements, fewer barriers, it will get to the people we want,” Thompson said. “We think it will increase access (through self-testing), but it only does that if we think about what the barriers to access are and help people get past them.”

Dr. Caitlin Lee, director of medical quality and director of health equity at Wesley Community and Health Center, is passionate about ensuring everyone has access to appropriate care, regardless of insurance status. (Photo by Caitlin Lee)

Wesley Community and Health Center is focused on creative solutions that break down barriers to access, Lee said.

“There's a lot of room to be creative,” she said. “Some of our providers are primarily providing care in our mobile clinics, and I think the self-collection kits will play a big role for those populations, especially homeless populations. … I think there's a much greater opportunity to expand our reach at the public health level with this approach.”

Current guidelines state that self-examination can only be performed in a clinical setting, but health care providers believe the test could improve access to cervical cancer screening.

“These tests are done with a cotton swab or tampon applicator-like device, so they're ideal for women who come into the clinic but can't get a Pap test,” Thompson says. “People who have had trauma or who use their legs or hips in an unusual way, who previously would have had difficulty inserting a speculum or lifting their feet into stirrups, can now have a sample taken.”

Lee expects self-administered tests to be available in clinics by late summer or early fall, with FDA-approved at-home tests also expected in the future.

Overall, health care providers say they are hopeful about global changes in cervical cancer screening and incidence rates.

“Cervical cancer and death are very real,” Petersen-Hock said, “and I think it has the potential to change lives all over the world.”