Counties using PCR tests to curb sexually transmitted infections

Experts say rapid PCR technology being used to test for sexually transmitted infections in Pima and Cochise counties could be a solution to curbing climbing rates of several common pathogens.

Pima County is using rapid testing to help fight a statewide syphilis outbreak, in which the largest increases in cases are in women and newborns. 

And in Cochise County, a large primary care provider is one of two organizations in the United States piloting new rapid testing technology to quickly diagnose chlamydia, gonorrhea and trichomoniasis, three common STIs.

Syphilis cases surging in women 

Pregnant women can pass syphilis to unborn children, and syphilis during pregnancy can cause miscarriage, stillbirth and infant death.

Babies who survive can have irreversible damage to the skin, bones, joints, eyes, ears and brains, and untreated syphilis in adults can damage a person's brain, nerves, eye blood vessels, bones and more, according to the Arizona Department of Health Services.

Timely testing and treatment can reduce negative health outcomes for mother and baby, the department stresses.

Since 2015, the yearly average of syphilis cases in women in the state has increased 449%, according to ADHS data.

Between 2016 and 2019, the number of babies born with syphilis doubled each year, and 10 of the 166 babies born with syphilis last year died.

As of May 31, 934 cases of syphilis have been diagnosed in the state, with 170 of those diagnosed in Pima County.

Syphilis and congenital syphilis rates are rising nationwide and causing concern among experts, especially considering that the disease is highly preventable, said Michael Lopez, HIV/STD program manager for the Pima County Health Department.

Before the COVID-19 pandemic, officials in Pima County and beyond were seeing an increase in diagnosed STIs, with one thought being that the higher numbers were due to more people being tested, Lopez said.

"With the advent of PrEP, more people have begun engaging in screening. Hopefully we're seeing a normalization in testing," Lopez said. "But we saw a decrease (in testing and rates) during COVID, because in our own jurisdiction and statewide, a lot of clinics had to slow down or minimize encounters."

In addition, people who felt they were at risk of contracting COVID by visiting a doctor or clinic also held off on testing for awhile, Lopez said. But once stay-at-home orders and other precautionary measures were lifted, health-care providers in Pima County began to see more people coming in for testing.

"We're seeing an increase (in STI rates) again, but I feel like for Tucson, we're staying within those kind of 'average' numbers. They're increasing, but they're still very similar to years' past," Lopez said. "But with syphilis and congenital syphilis, we're seeing an exception."

As recently as 2015, there were no reported cases of congenital syphilis in Pima County, but by 2017, three had been reported. By 2020, that number had risen to 27 and as of October 2021, the county health department recorded 25 cases of syphilis involving pregnancy.

Advantages of rapid testing

Lopez said the burden tends to fall on health-care providers to bring awareness to the importance of taking a complete sexual health history, while also taking  a nonjudgmental approach that helps empower people to know their health status.

But he said everyone can play a part in destigmatizing testing and helping to get out the message that even if a person doesn't believe they're at risk for contracting an STI, there's always a risk if they're engaging in sexual activity.

At the county health department's three locations, providers are using a combination of rapid testing for syphilis and HIV and standard testing for other STIs.

The faster testing helps prevent missed treatment after contact is lost with a patient, which can easily occur during the standard 24 to 72 hours it takes to get back results from a standard test, Lopez said.

Factors such as homelessness and housing instability, as well as substance use issues, contribute to a higher risk of people being exposed to an STI and unable to test.

"In the case of our community disease investigators, when a client discloses a partner in a confidential respect, sometimes we can't find these people again," Lopez said.

Being unable to locate a person's partner or even the patient themselves after that first visit is more than a barrier to treatment, Lopez said. It's a roadblock. In many cases, he said, it's best to just treat for an STI, even if a provider is waiting for test results to come back.

"We're working with community partners to enhance our mobile outreach testing in areas where homeless people might utilize them," Lopez said. "I think that as a community, we need to be advocating for people to get tested and finding different means in terms of prevention and really trying to think outside of the box about where our outreach efforts need to be."

With a rapid syphilis or HIV test, a few drops of blood and 20 minutes will yield a preliminary result, Lopez said.

To combat rising syphilis cases, the health department has been engaging in a social media campaign and placing ads at bus shelters around Tucson.

"We can't just focus on one aspect. We have to see the full picture and focus on both prevention and care," Lopez said. "The messaging needs to be, 'If you're sexually active, incorporate testing as part of your sexual health routine.'"

Sexual Health Click Test

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Chiricahua Community Health Centers Inc., Southeastern Arizona's largest primary care organization, is piloting the new rapid STI testing technology to quickly diagnose chlamydia, gonorrhea and trichomoniasis.

Visby Medical's new PCR testing device uses self-collected vaginal swab samples to produce rapid, accurate results. After a sample is collected, the swab is inserted into a collection solution and transferred to the device. The provider presses a button and 30 minutes later will get a "positive" or "negative" result for each of the three pathogens, said Visby's chief medical officer, Dr. Gary Schoolnik.

The device — called the Sexual Health Click Test — is the size of a cell phone and the only thing it needs to run is electricity. When the test is complete, the single-use device can either be discarded or recycled back through Visby, Schoolnik said.

"The game-changing part of this is how rapid this is and that it can be done anywhere by anyone," he said. "These three pathogens have a significant impact on women's health, and two are the main cases of pelvic inflammatory disease (an infection of the reproductive system)."

Schoolnik, an infectious disease specialist at Stanford Medical School, said he thinks rapid PCR testing like Visby's will "transform" care and help curb the STI epidemic if it's widely used.

The device has been approved for point-of-care use at retail pharmacies, urgent care centers, emergency departments, OBGYN offices, student health centers and mobile vans, but for now, it's only being piloted in two locales.

In addition to use in all of Chiricahua Community Health Centers Inc.'s rural Arizona facilities, the devices are also being tested in an urban setting in Rhode Island, with mobile vans going out into areas with a high risk for STIs, Schoolnik said.

Since many people turn to emergency rooms and urgent care centers when they have concerns about their sexual health, Schoolnik hopes the Visby device will soon be used in those locations. He's also hoping to see them in pharmacies, as pharmacists now perform a variety of primary care duties, including vaccinations and more.

The device costs about $60, which can be reimbursed by most insurance, so  Schoolnik said the hope is that the product is affordable for most patients.

Under-treatment and over-treatment of STIs are common in many settings that use standard testing, either due to loss of contact with a patient or overprescribing in cases where a provider fears they'll lose contact with the patient, he said. Rapid testing can prevent both, Schoolnik said, while also providing "a teachable moment."

Providers can talk about safe sex while a person is waiting for their test results and, when the 30 minutes are up, can move onto treatment options, testing for the person's partner or partners, and prevention of future STDs after having established that initial rapport, he said.

"Dialogue is important to changing behavior with people," Schoolnik said. "When you have a moment and you have a compassionate physician and a patient who's just learned what they have, it can really change the behavior as well as get the patient properly treated."

A 2015 study on the use of rapid testing in chlamydia and gonorrhea cases showed that the technology enabled faster treatment, reduced infectious periods and led to fewer infections and medical costs, according to a 2018 article in the International Journal of STDs and AIDS.

Game-changer for clinicians

In 2020, Cochise County reported 420 cases of chlamydia and 108 cases of gonorrhea, according to the state health department. Those numbers dropped slightly in 2021, to 403 and 91, respectively, and as of May 31, there were 156 cases of chlamydia and 24 cases of gonorrhea diagnosed in the county, ADHS data shows. 

Untreated chlamydia can cause pelvic inflammatory disease in women, which can lead to infertility and chronic pain. In men, untreated chlamydia can cause pain and swelling in the testicles.

Untreated gonorrhea can spread to the blood and cause disseminated gonococcal infection, which can be life-threatening, according to the U.S. Centers for Disease Control and Prevention.

In 2019, Arizona ranked 14th in the country in chlamydial infections and 16th in gonorrheal infections, the CDC says.

With rising STI rates across the state and along the U.S.-Mexico border, infection control has become a joint priority between officials in Cochise County and in Agua Prieta, Sonora.

Chiricahua Community Health Centers Inc. serves more than 30,000 patients each year through its 14 fixed-site medical clinics and seven mobile-medical and mobile-dental units. The nonprofit organization sees patients throughout the more than 6,200 miles of Cochise County.

For the first year of the pandemic, CCHCI provided most of its care through telehealth, causing the number of STI tests it was administering to drop. But CCHCI Chief Medical Officer Dr. Darlene Melk said with schools having returned to in-person and more patients returning for in-person visits, STI rates in the region are starting to pick back up.

Thanks to a grant from Visby Medical, CCHCI has received nearly 400 tests to date, with Melk saying the organization is in the process of evaluating if it can continue with Visby rapid testing after the grant ends.

"From a practical perspective, this is a marvelous project," Melk said. "But tests cost money and it's an investment up-front even if we're able to get insurance to reimburse."

As a federal qualifying health center, CCHCI has to treat all patients, regardless of their ability to pay. With many patients not having insurance, Melk said she and others are "very motivated to make this a sustainable test that we can offer to our patients in the future."

Melk called the Visby device a game-changer from a clinician's perspective. It allows providers to counsel and treat patients on the spot, she said, while not having to worry about losing touch with the patient or about additional exposure to partners while the patient is waiting for results.

She likened it to the early days of COVID-19 testing, when patients had to wait upwards of a week to get results. And when results finally did come, questions still remained about who had the person exposed and were they really following isolation protocols, Melk said.

With instant results, those concerns — which are similar when it comes to STIs — are no longer an issue, and the fast turnaround time cuts down on provider workload, Melk said.

"It doesn't matter where you're practicing as a clinician. There's so much added work on your staff and you to track down a patient when you get a positive result," she said. "It's really important that they know, but you can't always find them right away."

The reception from CCHCI patients was resoundingly positive, as well, Melk said.

"Patients loved the convenience of having the results right then and there. They were very pleased with the ease," she said, adding that innovations such as these show that people are starting to look at medicine through a public health lens. "Scientists are working like crazy in the background to make health care more accessible for everyone."