Treatable sexually transmitted infections (STI) such as Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) remain highly prevalent in the United States and worldwide.1,2 Despite routine STI screening recommendations in many countries, case rates continue to increase. For example, chlamydia rates increased by 6.9% while gonorrhea rates increased by 18.6% in the United States from 2016 to 2017, the last year for which we have surveillance data.2 One potential contributor to our lack of success in reducing the number of cases is the lack of access to and utilization of screening services.3 Access to screening is limited by the number of clinical venues that offer routine screening while utilization is likely impacted by convenience, cost, and stigma.4 Point-of-care (POC) testing has the potential to increase access to screening while at the same time reducing stigma as the process of screening becomes routine. Any patient regardless of gender, sexual orientation, or behavior could be screened by self-collected samples during a healthcare visit in a variety of settings, thereby reducing any embarrassment that may have prevented them from seeking testing at a specialty clinic (e.g., a sexually transmitted disease clinic).
Currently, nucleic acid amplification tests are performed predominantly in reference laboratories, and despite the reduction in total test time as assays have improved, results are often not available for 1 to 2 weeks after sample collection due to transport of samples, batching of test runs, and result communications. Because of this delay, patients with positive results may be left untreated for extended periods. Point-of-care testing creates the potential for same-visit results, allowing for treatment before patients leave the clinic. We have long known that even with sensitivity as low as 65%, a POC test actually can actually increase the number of treated STI cases when compared with culture and laboratory-based molecular testing because of same-day treatment.5 With a sensitivity of 92%, we can assume that the POC used in this study would allow for even larger increases in the number of treated cases.6 In addition to same-visit treatment, rapid test result delivery can improve the appropriateness of treatment over treatment based on epidemiologic or empiric data.7,8
Numerous studies have described clients' and clinicians' endorsement of hypothetical wait times, typically up to 30 minutes.9,10 Other studies have shown that in remote settings, wait times in excess of 90 minutes are acceptable,11 but these data are not likely generalizable to young people (those at highest risk for chlamydia) in the United States. Further, despite the rapid availability of results, many people utilizing clinics with a 90-minute test do not receive their results during the actual visit but return for treatment which can be delayed by a day or two.12,13 Limited research has been performed to assess the willingness of patients to wait for results based on the actual time until results were available using more rapid tests in real-world clinical settings in the United States. Further, there have been limited data that demonstrate whether such testing would disrupt clinic flow in real clinical settings.
We collected data from patients attending a university student health clinic in Birmingham, AL, from whom we sought to determine the acceptability of wait times using a 30-minute POC assay for detection of CT and NG. We also surveyed the clinic and site laboratory staff to determine their perspective on the feasibility of implementing such a test. The study protocol was reviewed and approved by the University of Alabama at Birmingham Institutional Review Board. Consent was obtained from each participant before any study activities.
During routine clinic visits, patients checking in at a computer kiosk were asked by a research assistant whether they were electing to undergo STI screening during that office visit and whether they would be interested in participating in a research project. Patients who were willing to learn more were consented once they were called into an examination room, but before any interaction with a health care provider. Consenting participants were asked to provide a vaginal swab or a urine specimen (men only) for the study. Participants were then requested to see the research staff at the completion of their routine visit. All participants were informed that they would not receive test results from the experimental assay since the assay had not been cleared by the Food & Drug Administration at that time. All participants were provided with standard of care CT/NG test results when they became available (within 1 week). Research staff (who were not laboratory trained) performed CT/NG testing using the binx Health io assay [io] (binx Health Ltd., Trowbridge, UK). This assay has been described under the name Atlas Genetics io CT/NG assay.6 At the completion of the office visit, participants were told the time remaining on the 30-minute experimental assay and the following data were collected in the order shown below:
- How satisfied are you with the sexual health component of today's visit? (1—very dissatisfied, 10—very satisfied).
- If your test result were available now, what level of satisfaction would you have with today's visit? (1—very dissatisfied, 10—very satisfied).
- Your test will be available in X [actual time remaining provided to each participant] minutes. Although we do not have actual results today, would you have been willing to wait that long to get your results?
We reviewed patient charts to determine the date at which results of the standard of care test became available and when those results were communicated to the patient.
Finally, at the end of the study, clinic staff were asked to respond to two questions.
- Did you find that the POC test interfered with normal clinic flow?
- If this POC test were available in your clinic, would you implement it?
Overall 108 patients were enrolled in the study of which 83% responded that they would have waited for their results. For 24 (22.2%) participants, the experimental assay was completed by the end of the clinic visit, and no wait would have been required. The remainder of wait times ranged from 2 to 68 minutes. Although the assay requires only 30 minutes to complete, if samples were provided by more than one participant in close succession, a longer wait time occurred since only a single instrument was available for this study; 15 patients waited more than 30 minutes. All 52 (100%) patients for whom the wait time was less than 10 minutes stated that they would have waited for the results (Fig. 1A). Of the 20 whose wait time ranged from 11 to 20 minutes, 80% agreed to wait; of the 18 people with 21 to 30 minutes remaining, 72% agreed to wait; and, for the 16 people with wait times in excess of 30 minutes, 44% agreed to wait. There was no difference in willingness to wait based on gender (Fig. 1B). Overall, for participants who did not have to wait for the instrument to be available (93/108), the additional time they would have needed to wait for results ranged from 0 to 30 minutes with a mean time of 10.7 minutes (SD ± 10.7 min) (Fig. 2).
Patient satisfaction scores were subject to a ceiling effect because most patients were highly satisfied before being asked about the impact of the availability of CT/NG test results with a mean score of 9.8 (SD ± .55). Nonetheless, there was a measurable increase in satisfaction when the concept of receiving results during the clinic visit was introduced resulting in a mean satisfaction score of 10.0 (SD ± .17 P < 0.01). The mean time until the clinic received the results of the standard of care test was 7.9 days (SD ± 4.0), and the total time until the patient received results/treatment after their clinic visit was 10.4 days (sd ± 5.2). Finally, both the clinical and laboratory staff felt that collection of samples before interacting with a clinician and adding the performance of this POC assay to on-site activities did not disrupt clinic flow. Clinical staff universally endorsed implementation of this assay, or something similar, when it becomes commercially available. They responded that they change in patient flow required for sample self-collection before clinician interaction was not disruptive and that the space utilization was appropriate in the on-site laboratory. The laboratory staff felt that the assay would be easy to incorporate into their routine testing process.
The implementation of a rapid POC test in a clinical setting proved acceptable because 108 of the 109 patients that were approached participated in the study, collected their own samples, and met with research staff after the completion of their visit. The approach was feasible because the vast majority, nearly 90%, of students were willing to wait up to 20 minutes, and the mean time added to the clinic visit was less than 11 minutes. In the survey performed by Widdice et al,6 61% of the participants said that they would, hypothetically, wait 20 minutes for the results. Our study demonstrates that an even higher proportion of patients are willing to wait in a real clinical setting when presented with the possibility of rapid results. By changing clinic flow to allow collection of samples before engagement with a clinician, the wait times were predominantly in an acceptable range. However, extended wait times still occurred because of the utilization of only a single instrument. With multiple instruments, a significantly higher percentage of the wait times would be expected to be less than 30 minutes. In this clinic, having 2 to 3 instruments would have alleviated any unnecessary wait times.
Since the conclusion of this study, the io CT/NG assay has received clearance from the FDA. Access to this rapid, easy to use test could result in testing and treatment during the same visit which would have reduced the time to treatment in this study population by more than 10 days. Such rapid treatment has the potential to substantially impact the probability of both transmission and long-term consequences of untreated infections.
Our findings suggest the characteristics of a POC test are important for maximizing the potential for the technology to meet the needs of the staff and clients. In one physician survey, the time frame required was singled out as the most significant barrier to implementing POC testing in a clinical setting.10 With a well-designed clinic flow process, a 30-minute test will often allow for acceptable waiting times that would facilitate treatment before the end of the visit. However, because the number of patients willing to wait beyond 30 minutes declines substantially,14 a POC test with an extended run-time may only be useful in settings with a long patient visit process (e.g., emergency departments), in very remote settings where the wait time is less than the travel time, or in cases where patients are willing to return later in the day for treatment. Regardless of the wait time, POC tests offer very real advantages in terms of the number of cases treated and the accuracy with which specific infections are managed and their adoption should be encouraged where feasible. Although the sample size in this study is small, these findings are reflective of real world practice and thus of important consideration by STI control programs and clinics that would like to offer access to innovative sexual health care.
1. Newman L, Rowley J, Vander Hoorn S, et al. Global estimates of the prevalence and incidence of four curable sexually transmitted infections in 2012 based on systematic review and global reporting. PLoS One 2015; 10:e0143304.
2. Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017. Atlanta: Department of Health and Human Services, 2018.
3. Roth A, Van Der Pol B, Dodge B, et al. Future chlamydia screening preferences of men attending a sexually transmissible infection clinic. Sex Health 2011; 8:419–426.
4. Hood JE, Friedman AL. Unveiling the hidden epidemic: A review of stigma associated with sexually transmissible infections. Sex Health 2011; 8:159–170.
5. Gift TL, Pate MS, Hook EW 3rd, et al. The rapid test paradox: When fewer cases detected lead to more cases treated: A decision analysis of tests for chlamydia trachomatis. Sex Transm Dis 1999; 26:232–240.
6. Widdice LE, Hsieh Y-H, Silver B, et al. Performance of the atlas rapid test for Chlamydia trachomatis
and women's attitudes toward point-of-care testing. Sex Transm Dis 2018; 45:723–727.
7. Rivard KR, Dumkow LE, Draper HM, et al. Impact of rapid diagnostic testing for chlamydia and gonorrhea on appropriate antimicrobial utilization in the emergency department. Diagn Microbiol Infect Dis 2017; 87:175–179.
8. Wilson SP, Vohra T, Knych M, et al. Gonorrhea and chlamydia in the emergency department: Continued need for more focused treatment for men, women and pregnant women. Am J Emerg Med 2017; 35:701–703.
9. Gaydos C, Hardick J. Point of care diagnostics for sexually transmitted infections: Perspectives and advances. Expert Rev Anti Infect Ther 2014; 12:657–672.
10. Hsieh YH, Gaydos CA, Hogan MT, et al. What qualities are most important to making a point of care test desirable for clinicians and others offering sexually transmitted infection testing? PLoS One 2011; 6:e19263.
11. Natoli L, Guy RJ, Shephard M, et al. “I do feel like a scientist at times”: A qualitative study of the acceptability of molecular point-of-care testing for chlamydia and gonorrhoea to primary care professionals in a remote high STI burden setting. PLoS One 2015; 10:e0145993.
12. Whitlock GG, Gibbons DC, Longford N, et al. Rapid testing and treatment for sexually transmitted infections improve patient care and yield public health benefits. Int J STD AIDS 2018; 29:474–482.
13. Wingrove I, McOwan A, Nwokolo N, et al. Diagnostics within the clinic to test for gonorrhoea and chlamydia reduces the time to treatment: A service evaluation. Sex Transm Infect 2014; 90:474.
14. Hsieh Y-H, Hogan MT, Barnes M, et al. Perceptions of an ideal point-of-care test for sexually transmitted infections—a qualitative study of focus group discussions with medical providers. PLoS One 2010; 5:e14144.