Home-Based Testing for Sexually Transmitted Infections: Leveraging Online Resources During the COVID-19 Pandemic.

Abstract

The rates of sexually transmitted infections (STIs) have continued to increase in the United States.1 Mitigation of STIs is dependent on an integrated approach, including diagnosis of infected individuals, followed by appropriate antimicrobial treatment to prevent onward transmission. These prevention efforts, essentially unchanged since the 1930s, are often hindered by the lack of screening programs for asymptomatic persons and access to testing for some symptomatic individuals. Since March 2020, the coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), has led to massive challenges for sexual health screening and testing. With the closure of clinics, access to clinical care has been interrupted. Many public health department resources have been redeployed to address the COVID-19 pandemic.2,3 A survey of health department sexually transmitted disease (STD) programs and clinics, conducted by the National Coalition of STD Directors in mid-March 2020, found that 83% of STD programs were deferring STD services and that 60% of clinics were experiencing reduced capacity to treat STIs.2 A follow-up survey (June 2020) by the National Coalition of STD Directors found that of the STD programs surveyed, the majority (78%) of STD/HIV health departments’ workforce has been redeployed to assist with the COVID-19 emergency response and that 98% of these programs are relying on phone calls and text messages to reach clients for STD, HIV, and/or COVID-19 interviews.3 In the State of Maryland, for example, many of the clinics offering STI services curtailed in-person activity in mid-March 2020 and suspended STI testing, which were deemed nonessential services. Recognizing that many jurisdictions were pivoting toward phone or telemedicine triage, on April 6, the Centers for Disease Control and Prevention issued guidance to STD prevention programs (https://www.cdc.gov/std/dstdp/DCL-STDTreatment-COVID19-04062020.pdf) with therapeutic options limited to symptomatic patients who are treated empirically based on syndromic presentations. In order to address the challenges associated with STD services during the COVID-19 pandemic, innovative testing approaches not requiring in-person visits needed to be implemented. Online STI mail-in testing of self-collected samples is an attractive option in pandemic times. I Want The Kit (IWTK), an online outreach program, offers free STI testing kits for home collection, mail-in return of samples, and testing by a Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP)–certified laboratory.4–7 Participants obtain results on the Health Insurance Portability and Accountability Act (HIPPA)–secure website, and positive results are sent to the clinic selected by the participant for treatment. Founded in 2004, IWTK was the first mail-in STD testing site and provides free and confidential testing for chlamydia and gonorrhea to residents of Maryland; Washington, DC; and Alaska. To date, IWTK has provided online STI testing to more than 10,000 participants and tested more than 20,000 genital, rectal, and oropharyngeal specimens. The “I Know” program (www.DontThinkKnow.org) offers chlamydia and gonorrhea home-based testing program for women 25 years and younger living in San Diego County and targets Latina and African American women. The program, initially developed by the Los Angeles Department of Public Health, screened more than 1500 women in its first year and found a positivity rate of greater than 8%.8 The “TAKEMEHOME” program (www.bhocpartners.org/home-testing/) is a new free HIV home testing program offering a centralized system for HIV test kit ordering and distribution designed to reach men who have sex with men (MSM) who use dating apps. The program will soon include options for STI testing and HIV testing using dried blood spots. These programs provide a reliable way of accessing STI/HIV tests and results management without the need to appear in person at clinical settings, where the risk of COVD-19 exposure and transmission is high. Using IWTK, we leveraged an existing public-academic partnership to catalyze rapid uptake of IWTK services during the COVID-19 pandemic, particularly in Baltimore City, in Maryland at large, Alaska, and Washington, DC. After a 3-week hiatus due to the COVID-19 emergency shutdown of operations at Johns Hopkins University, IWTK reopened on April 6, 2020, to provide STD testing during the closure of STD clinics. All of our partners referred clients to IWTK to fill the critical STI testing gaps, particularly those clients on preexposure prophylaxis for HIV. After the reopening, the IWTK program experienced a significant increase in the number of STI testing kit orders, the number of HIV home testing kits requested, and the number of STI tests performed (Fig. 1). Although IWTK has successfully provided access to online STI testing for more than a decade, the direct referral from trusted health department personnel to the online testing service was a key component of the program’s success during the COVID-19 pandemic.Figure 1: Sexually transmitted infection testing and distribution of HIV home testing kits by IWTK before and during the COVID-19 pandemic. CT, Chlamydia trachomatis; NG, Neisseria gonorrhoeae. *Stay at home orders for Maryland; Washington, DC; and Alaska.HIV self-testing at home has gradually increased in popularity owing to ease of use and convenience, while providing an option to counter barriers for testing and reaching those at high-risk who otherwise rarely test.9 As part of the CDC’s Ending the HIV Epidemic plan, Baltimore City residents are also offered free OraQuick test kits through IWTK for at-home HIV testing, which also accelerated significantly during the COVID-19 pandemic (Fig. 1). A similar pilot study in Oregon, using an app-based approach, targeted MSM and distributed 248 kits for home-based HIV testing from March 31 to May 31, 2020.10 According to participants’ feedback, home-based HIV testing was “easy” and “convenient,” “testing can be performed in the safety and privacy of one’s home without fear of judgment,” and that the program can help to address existing gaps and barriers to HIV testing. These home testing programs and others throughout the United States are examples of the high degree of acceptability for HIV home testing and highlight the impact that home testing can have on decreasing barriers for HIV testing. Currently, 4 to 7% of the home-collected samples from IWTK participants are positive for chlamydia and/or gonorrhea. In comparing positivity rates before the COVID-19 pandemic (September 2019 to February 2020) with data collected during the pandemic, we observed no significant differences in the rates between the two periods (Fig. 1). A possible interpretation for the sustained positivity rates during the pandemic is that participants continue to engage in high-risk behaviors during the pandemic, ignoring CDC’s social distancing recommendations. However, more behavioral data are required to better understand sexual behaviors during COVID-19. Most participants seeking testing through IWTK during the pandemic were referred through public health departments and are likely representative of individuals at higher risk for STIs, who would normally visit public health department STD clinics for STI testing. Lastly, the sustained chlamydia and gonorrhea positivity rates during the COVID-19 pandemic suggests that IWTK is providing STI testing to those at risk of adverse sexual health outcomes who otherwise would not have access to STI testing during the pandemic. Home-based sample collection for STI testing provides many benefits over traditional clinic-based testing, including convenience, simplicity, and privacy, which help to overcome stigma for those patients who may be reluctant to seek clinic-based testing for STIs. Considering the success of online programs in providing home-based STI/HIV testing during the COVID-19 pandemic, such programs need to be further developed or expanded. To increase access to this innovation, Internet-based programs offering home-based sample collection could partner with a public health or commercial laboratory to increase capacity for testing. Laboratories would have to perform validation studies to ensure that the integrity of the tests is not affected by the collection method or by the transport of the samples to the laboratory. The validation of home-collected samples by commercial laboratories would also benefit telehealth providers in many settings where samples could be collected outside of the clinic. Although home collection has proven to be a viable alternative to increase STI testing, the return of testing kits by participants remains a challenge. Currently, approximately 65% of IWTK participants return STI kits for testing. In order to achieve maximum return on investment, increasing the return rates of STI testing kits should be a priority for any program. A simple strategy to increase return rates is by notifying participants, through e-mail or text message, of the pending status of their order. Lastly, result reporting and treatment for those with an STI could be challenging in settings where access to medical services is limited. In order to facilitate the follow-up and treatment process, programs offering STI testing via home collection need to engage with local public health partners. Given the increased popularity of home collection for STI testing, online for-profit sites offering STI testing services have proliferated in the recent years. However, these sites are not regulated by the Food and Drug Administration (FDA) and the out-of-pocket costs may be prohibitive. The FDA should begin to regulate home-collection programs for STI testing and work with commercial companies to validate home collection particularly for public health programs. There are barriers to large commercial or state laboratories adopting plans to process home-collected samples, including the necessity for either (1) performing validation studies for modifying a package insert or (2) commercial companies to perform a home-collection trial to demonstrate the accuracy of the preanalytic component in addition to the postanalytic phase for FDA clearance. An article by Hobbs et al.11 published after a National Institutes of Health/CDC/FDA/commercial company/academic workshop outlined the barriers to, and research studies that would be required to support FDA clearance of self-collected swabs for STI testing. IWTK has expanded to fill a testing gap precipitated by the COVID-19 pandemic. Online testing is a key element in the STI diagnosis and treatment ecosystem; however, there are limitations to its reach. Certain groups are effectively excluded because of language and literacy barriers, whereas others lack Internet access or a stable home address. Furthermore, the ongoing shortage of flocked swabs (necessary for home collection of samples) due to COVID-19 threatens the longevity of online testing. The rapid uptake in usage (orders and STI tests performed) and success of the IWTK program during the COVID-19 pandemic suggest that self-collection of samples at home using an online outreach program is a suitable option to enhance uptake for STI screening in the context of greatly reduced clinical services. Given the acceptability and cost-effectiveness of home testing programs, home collection could be used as a strategy to complement clinic-based screening.12,13 In order to decrease barriers to STI testing, increase ease of testing, and promote sexual health, online testing programs need to be expanded, especially when access to clinics and testing facilities is limited. Furthermore, centralized clinical laboratories need to prepare for testing of home-collected specimens by doing appropriate validations of self/home-collected samples to maximize accessibility to users, minimize the burden on health care workers, and decrease the unit cost of STI testing. Regardless of the type of test (STI or HIV), online-based testing programs allow participants the opportunity to access accurate, free, and confidential testing for STIs/HIV without the risk of exposure to SARS-CoV-2. Furthermore, public health departments can play a critical role in promoting online usage given their trusted role in this health care space.