Direct-to-Consumer Sexually Transmitted Disease Testing

Rates of sexually transmitted diseases (STDs) have increased dramatically in the United States in recent years, with record highs reported for syphilis, gonorrhea, and chlamydia by the Centers for Disease Control and Prevention (CDC).¹ In addition, CDC data reveal that half of all new infections are acquired by individuals aged 15 to 24 years, and females in this age group comprised 45% of new chlamydia cases in 2017.^1,2

Despite these soaring rates, sexual behavior and STD risk are not common topics of discussion between patients and clinicians, according to research conducted by Quest Diagnostics, and 51% of women aged 18 to 24 years stated that they do not wish to discuss these topics with their healthcare providers.³ The results further indicated that clinicians did not offer STD testing to 49% of women surveyed.

As one of many potential solutions to these problems, several studies have shown promise for direct-to-consumer testing. Much of the research on this topic has focused on self-testing for HIV, which has been found to improve testing rates and early diagnosis in a range of studies, although not all findings have been consistent with those observations.⁴ However, results have been sufficiently compelling that the World Health Organization now recommends self-testing as an option for HIV testing.

In a 2017 meta-analysis of randomized controlled trials comparing self-testing with standard testing for HIV (with a combined total of 4145 male participants), self-testing was found to roughly double the rate of testing among men in general, as well as among men who have sex with men. A similar increase was demonstrated in the likelihood of an HIV-positive diagnosis. Importantly, there was no evidence of harm associated with self-testing.⁵ 

As noted in a 2019 paper published in the Journal of the International AIDS Society, the number of undiagnosed HIV infections is one of the major remaining challenges in reaching the UNAIDS 95-95-95 goals for 2030.⁶ “Many of the remaining undiagnosed individuals are presumably not engaging with HIV services, and novel avenues to HIV testing services that overcome both stigma and structural barriers are needed… to reach these remaining undiagnosed individuals and effectively link them to treatment,” wrote the authors. HIV self-testing “has developed substantially in recent years and is now considered a new and critical HIV response strategy in controlling the epidemic.”

Other findings support the reliability of self-testing for chlamydia and gonorrhea. One study demonstrated similar or superior detection rates compared with provider-administered testing, while other research showed the effectiveness of self-testing among college students.^7,8

Several self-testing kits for STDs are currently available for consumer purchase, and Quest joined the market in April 2019 with the launch of direct-to-consumer testing options for chlamydia, gonorrhea, syphilis, HIV, hepatitis B and C, and trichomonas. In all states except Alaska, Hawaii, Oklahoma, Arizona, and Indiana, patients can order a test online through QuestDirect and then schedule an appointment for bloodwork directly at a Quest patient service center.

To learn more about these products and related implications for clinicians, Infectious Disease Advisor interviewed Damian Alagia, III, MD, FACOG, FACS, medical director of women’s health at Quest Diagnostics.

Infectious Disease Advisor: What are believed to be the reasons why STD rates are increasing?

Dr Alagia: There are multiple reasons, including behavioral factors that reduce screening, diagnosis, and treatment. We’ve conducted research that provides some important insights regarding STDs and the interface between patients and clinicians. For one thing, STDs are often asymptomatic, so individuals may not know they are infected and may unknowingly pass disease on to their partners. The only way to know with certainty if an individual has an STD is to screen for the presence of infection. Yet, our research with primary care physicians found that many healthcare practitioners feel they “can tell” when a patient has an infection. That suggests patients may not be getting screened based on risk and according to medical guidelines.

We also learned that patient-physician communication about STDs is seriously lacking. For example, we found that obtaining a correct patient history is the largest challenge to assessing STD risk, based on both patient reluctance to share and clinician discomfort and limited time to ask, and that clinicians are most likely to assess STI risk in females age 25 to 65 years when the patient brings up new sexual behaviors or symptoms. In light of these epidemic rates, clinicians need to operate under the assumption that all patients are at risk, and that their role is critical to overcome barriers, such as stigma and communication discomfort.

Infectious Disease Advisor: What are the benefits and potential drawbacks of direct-to-consumer STD testing?

Dr Alagia: In a public health emergency like that of STDs, one important strategy is to provide options to patients through all possible means, and wherever they are — but that doesn’t mean that clinicians should be taken out of the process. Our research shows that consumers believe that the ability to purchase certain tests and receive results would facilitate better communication with their physicians and improve their health. Luckily, medications can often quickly cure many common STDs, and in more complex diseases like HIV, physician guidance can facilitate access to medications that can be lifesaving.

A positive test result doesn’t necessarily lead to action. Clinicians are critical to provide linkage between results and diagnosis and treatment. The risk for some other direct-to-consumer offerings that don’t provide linkage to care is that infected individuals won’t get treated and could spread infection to others.

Infectious Disease Advisor: What happens if a patient tests positive with direct-to-consumer testing?

Dr Alagia: Results are available through MyQuest, our secure online patient portal. With our consumer-initiated STD tests and panels, a physician with our oversight provider network will contact the patient if his or her results are out of range to offer an immediate consult. These physicians may provide treatment for certain conditions in some states and recommend further medical follow-up. We also strongly encourage patients to share their results with their personal clinicians, which can also be done through MyQuest’s MyCircle feature.

Infectious Disease Advisor: What are the relevant implications for clinicians?

Dr Alagia: It is our hope that this consumer-initiated testing complements and promotes dialogue between clinicians and their patients, and subsequently improves the rate of STD screening. We believe that providing consumers with additional options for testing will lead to improved communication going forward, and will help clinicians provide appropriate treatment to potentially eliminate long-term negative outcomes and further transmission of disease.  

Infectious Disease Advisor: What are remaining needs in this area, in terms of research, education, or otherwise?

Dr Alagia: The key is education. Patients — and especially young women ages 15 to 24 years — need to understand that STDs are highly prevalent, that they are often asymptomatic and can have serious health consequences if not treated, that protecting themselves from infection is critical, and that screening and treatment are available to them. They need to hear that in doctors’ offices, at home, in school, and from other trusted individuals. We have to remove the stigma of shame that prevents people from being screened and treated.

Clinicians must also acknowledge the importance of better communicating with their patients and having open conversations about their patients’ sexual behavior so that they may obtain a more thorough patient history and accurately identify patients who may be at high risk for STD infection.

The final piece of this puzzle is using proper coding in the electronic medical record to flag patients at risk and to prompt screening at future visits. Our research demonstrated that only 4 in 10 health care providers were aware of STI-related International Classification of Diseases-10 codes, including codes such as Z72.51, Z72.52, and Z72.53 to flag high-risk behavior. Health systems should help clinicians to understand and utilize the most accurate diagnosis information, and also to document it in the patient’s medical record on all laboratory orders for STI testing. That will also help promote screening to reduce STD rates, improve health outcomes, and reduce costs in the healthcare system.

References

1. Centers for Disease Control and Prevention. New CDC analysis shows steep and sustained increases in STDs in recent years [press release]. https://www.cdc.gov/nchhstp/newsroom/2018/press-release-2018-std-prevention-conference.html. August 28, 2018. Accessed July 28, 2019.

2. US Department of Health & Human Services. Adolescent Development and STDs. https://www.hhs.gov/ash/oah/adolescent-development/reproductive-health-and-teen-pregnancy/stds/index.html. Reviewed March 28, 2019. Accessed July 28, 2019.

3. PR Newswire. Quest Diagnostics Launches New Consumer-Initiated STD Tests Through QuestDirect™. https://www.prnewswire.com/news-releases/quest-diagnostics-launches-new-consumer-initiated-std-tests-through-questdirect-300833747.html. April 18, 2019. Accessed July 28, 2019.

4. Cushman TA, Graves SK, Little SJ. Attitudes and preferences regarding the use of rapid self-testing for sexually transmitted infections and HIV in San Diego area men who have sex with men. Open Forum Infect Dis. 2019;6(3):ofz043.

5. Johnson CC, Kennedy C, Fonner V, et al. Examining the effects of HIV self-testing compared to standard HIV testing services: a systematic review and meta-analysis. J Int AIDS Soc. 2017;20(1):21594.

6. Wong V, Jenkins E, Ford N, Ingold H. To thine own test be true: HIV self-testing and the global reach for the undiagnosed. J Int AIDS Soc. 2019;22(Suppl 1):e25256.

7. Sexton ME, Baker JJ, Nakagawa K, et al. How reliable is self-testing for gonorrhea and chlamydia among men who have sex with men? J Fam Pract. 2013;62(2):70-78.8.

8. Habel MA, Brookmeyer KA, Oliver-Veronesi R, Haffner MM. Creating innovative sexually transmitted infection testing options for university students: the impact of an sti self-testing program. Sex Transm Dis. 2018;45(4):272-277.