In 2016, rates of all reportable sexually transmitted infections (STIs) marked upward swings. In fact, the more than 2 million new cases of chlamydia, gonorrhea, and syphilis set a new record high. Timely STI testing is essential for preventing transmission and for protecting health. However, current testing rates in many at-risk groups are abysmal. For example, although half of new STIs occur in young people age 15 to 24, most individuals in this group have never been tested for an STI (J Adolesc Health 2016;58:512-9). Now, some companies—and even government health labs—believe that they have a solution for boosting test rates: providing testing outside of traditional settings and with varying degrees of physician involvement.
In recent years, the resources available to support STI testing have decreased. For example, the Centers for Disease Control and Prevention reports that in 2012, 52% of state and local STI programs experienced budget cuts, translating to reduced clinic hours and even closures. Given limited provider availability, “trying to schedule an appointment to be seen can be nearly impossible,” said Peter Leone, MD, professor of medicine at the University of North Carolina at Chapel Hill.
Appointment availability is not the only barrier to STI testing, according to Edward Hook III, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham. “In our country, people tend to be nervous or embarrassed about talking to doctors about their sexual behavior, or worried their doctors might think less of them if they ask for STI testing.” Leone noted as well that “most physicians aren’t particularly good at or comfortable with taking sexual histories.”
In response to these challenges, a variety of innovators are beginning to experiment with approaches to making STI testing more accessible and private. The extent to which physicians are involved varies, but all of these approaches rely heavily on the internet.
Is a Doctor in the House?
On one end of the physician-involvement spectrum sits Biem, a startup whose name comes from the phrase, Break In case of EMergency. “The idea is that in your time of need, we are there,” said Art Rastinehad, DO, a urologist by training and one of the company’s co-founders. Biem bills itself as a virtual sexual health clinic and provides telemedicine services to connect clients in New York with physicians who order STI tests based on video consultations. Test samples are then collected either at a nearby lab—Biem contracts with Quest and LabCorp—or by a technician during a home visit. Clients access their results online, using the secure Biem app, which features an anonymous network that alerts users if one of their partners who also uses the app tests positive for an STI.
Biem launched in June, and in its first month the app was downloaded more than 1,000 times. The company is securing funding to expand to 10 major U.S. cities by mid-2018, with a focus on New Jersey, California, Florida, Texas, Washington, D.C., Virginia, and Maryland. As this expansion progresses, Biem also is working on integrating Quest lab results with the Biem app—so that even users who are not tested through Biem’s physicians will be able to access their results online.
Rastinehad reported that the company’s clients are about evenly divided between men and women, and many are in the 25- to 34-year-old age group. A significant proportion are interested in accessing HIV pre-exposure prophylaxis, which requires HIV testing every 3 months. Finally, data show that many clients open their test results multiple times a day, suggesting they may be sharing their results with others, such as partners.
Another service, GetChecked-Online, takes physicians out of the equation to a greater degree. This program, offered by the British Columbia Centre for Disease Control (BCCDC), invites individuals at highrisk for STIs—those who call an STI clinic for an appointment but cannot be seen immediately, for example—to create an account on the GetCheckedOnline website. There, patients answer a series of questions to determine which tests are appropriate. All users are offered urine testing for chlamydia and gonorrhea, and blood testing for HIV and syphilis. Patients may be offered other STI tests based on their responses to GetCheckedOnline questions. Patients go to a local lab where blood samples are taken for HIV, syphilis, and hepatitis C testing. While at the lab, clients also self-collect urine or swab samples for chlamydia and gonorrhea testing. After the province’s public health labs analyze the samples, patients access negative test results online; the STI clinic calls them if results are positive.
Since the service launched in 2014, nearly 5,000 GetChecked-Online accounts have been created, users have been tested nearly 4,000 times, and more than 200 STI diagnoses have been made. Just under 30% of clients are repeat users, and the average user reports more barriers to STI testing than the typical clinic visitor, indicating that the program is successfully reaching at-risk populations. Moreover, “If you take into account clinical and administrative time, as well as testing costs, the cost of HIV testing [via GetCheckedOnline] is about half as much as clinic-based testing,” said Mark Gilbert, MD, medical director of clinical prevention services at BCCDC, who leads the program.
At the far end of the doctor-involvement spectrum sits MyHomeTests.com. This service allows patients to select and purchase their own home test kits online in all 50 states except New York, New Jersey, and Rhode Island, where direct-to-consumer testing laws require tests performed by the company to be ordered through a physician. Currently, MyHomeTests.com relies on marketing partners to educate at-risk groups about the availability of the tests it offers—and also how these tests should be selected and used. Samples are analyzed at the company’s in-house CLIA-certified and College of American Pathologists-accredited laboratory, and clients access their results online. However, if a patient receives a positive test result, a physician licensed in that state calls with the news to facilitate access to treatment. The laboratory also follows all state and county guidelines on reporting positive results, enabling local health departments to follow up.
Charles Sailey, MD, lab director of MyHomeTests.com, said this service took 4 years to develop. The company wanted to offer clients a full assortment of tests that required gathering only a single set of samples: vaginal swabs and dried blood spots for women, and urine and dried blood spots for men. “As far as we know, we are the only company that offers such a complete panel of tests with just these two types of samples,” said Sailey. Offering testing to clients in all 50 states has presented a challenge. “Many states have their own requirements in regard to proficiency testing and out-of-state licensure. In addition, each state has its own rules regarding direct-to-consumer testing,” he noted, and the company must meet all of them.
A Bright Future?
Many in the public health community applaud these new approaches. “Opening up more venues and options is the only way we are going to get STI rates down,” said Leone. Multiple studies have shown that the quality of test results from self-collected samples is equal or almost equal to those from provider-collected samples, according to Melanie Yarbrough, PhD, an instructor of pathology and immunology at Washington University School of Medicine in St. Louis. “I’m for self-collection as long as the instructions are clear and concise,” she said.
Even with these plusses, Yarbrough, Leone, and Hook all cautioned about STI testing models with limited physician involvement. “I worry there will be instances when people do not understand incubation periods for certain diseases,” said Yarbrough. “This may lead to testing too soon after a sexual encounter, and potentially misleading results.”
Leone emphasized the need for education on which body sites to test. “We’re now recommending all sites of sexual contact be screened for gonorrhea, including the throat and anus. If you aren’t screened at the right sites, you might be told that you are negative when you are really carrying an STI.” Finally, Hook noted that “a positive test is not the same as getting treated. It’s a great first step to treatment.” Linkage to care is essential, and he cautioned that not all home-testing companies offer consultation with a physician.
Because these new testing models have the potential to improve the accessibility of STI testing despite having some drawbacks, Hook predicted that “they are going to become more common.” And Leone suggested that public health funding could be used to expand these services to people without insurance or who historically have been left outside of the healthcare system.
Kristin Harper is a freelance writer who lives in Seattle, Washington. +EMAIL: [email protected]