Chlamydia (caused by Chlamydia trachomatis) and gonorrhea (caused by Neisseria gonorrhoeae) are common sexually transmitted infections (STIs) that can result in significant sequelae, including pelvic inflammatory disease, male and female infertility, ectopic pregnancies, chronic pelvic pain, stillbirths, and death, if untreated.1 The Centers for Disease Control and Prevention (CDC) reported 1,758,668 new chlamydia cases and 583,405 new gonorrhea cases in the United States in 2018.2,3 Chlamydia and gonorrhea affect most areas of the United States in endemic proportions; therefore, further testing advancements are essential to improve timely diagnosis and accurate treatment.
The current testing method used most commonly to diagnose chlamydia and gonorrhea infections in the United States is a nucleic acid amplification test (NAAT). These tests are accurate with 80% to 90% sensitivity and >98% specificity rates; however, it takes, on average, more than 48 hours before these results can be obtained by the treating provider.4,5 Without a confirmed diagnosis at the time of the patient visit, patients may be treated based on presenting signs and symptoms, known as syndromic management, or leave without treatment.4
Point-of-care (POC) testing reduces the diagnostic turnaround time by providing actionable results in an abbreviated wait time, which in turn impacts infection management. Point-of-care tests allow for patients to attend one single visit to obtain testing, diagnosis, and treatment. This platform of testing offers high value in situations such as management of chlamydia and gonorrhea, where the initiation of treatment window is time sensitive and specific treatment regimens are dictated by test results.6,7 It is also beneficial in settings such as urgent care, where visits are meant to be abbreviated and patient follow-up may be limited. Patients are increasingly seeking care in urgent care settings owing to the availability, affordability, and convenience.8 Urgent care visits for chlamydia and gonorrhea testing has increased 2- and 3-fold by patients already diagnosed with STIs from 2010 to 2014.9 Accurate and sensitive POC testing in urgent care could facilitate rapid results, reduce the need for multiple patient follow-up visits, and reduce presumptive treatment to promote antibiotic stewardship.4,6 Furthermore, POC testing may improve public health reporting, as well as partner notification and treatment, thus facilitating disease containment.4,6 However, clinical practices will need data in support of changing practice from laboratory-based to on-site testing. This study served to retrospectively evaluate chlamydia and gonorrhea treatment accuracy of adults, men and women, 18 years and older in 4 urgent cares in Northeast Iowa, using standard NAAT in a 6-month time frame. Outcomes of interest were overtreatment of patients who would ultimately test negative and undertreatment of positive patients who were not treated empirically under syndromic management guidance.
MATERIALS AND METHODS
The research design for this study was a retrospective, descriptive analysis using data collected from 4 urgent care clinics within a single, large health care system in Northeast Iowa over a 6-month period from June 1, 2018, to December 31, 2018. Retrospective data were collected from the electronic medical record of adult patients, men and women, 18 years and older who were tested for chlamydia and gonorrhea infections at any of the 4 clinics. Exclusion criteria included patients younger than 18 years and were limited to data from urgent care clinics only. Data collected included demographic information, testing method used for chlamydia and gonorrhea detection, presenting symptoms, known exposures, test results, test turnaround time, if treatment was provided and when (at the initial visit or after), if the treatment provided during the visit (if applicable) was appropriate based on current guidelines, and length of time for patient return. Testing was done by NAAT (Aptima Combo 2; Hologic, San Diego, CA) via provider-collected endocervical or urethral swab, patient-collected vaginal swab, or patient-collected urine sample. Providers were nurse practitioners, physician assistants, and a physician.
Assessment of appropriate treatment provided during the clinic visit follows current CDC 2015 sexually transmitted disease treatment guidelines for the treatment of chlamydia and gonorrhea in adults. Undertreatment was defined as patients having chlamydia and/or gonorrhea and not receiving empiric treatment at the time of their visit. Overtreatment was defined as patients not having chlamydia and/or gonorrhea and receiving empiric treatment at the time of their visit. Patients were empirically treated at the time of the visit based on provider discretion after considering factors of sexual history, prior STI diagnosis, known exposure to chlamydia and/or gonorrhea, and current symptoms. For this study, women were considered symptomatic if they had abnormal vaginal discharge, irritation, or pain; burning with urination; abnormal vaginal bleeding; or pelvic pain or cramping. Men were considered symptomatic if they presented with penile discharge, burning with urination, or testicular swelling. Rectal and oral symptoms were not considered for this study.
Each of the 4 urgent care clinics carries azithromycin tablets and ceftriaxone injections for the treatment of these infections specifically to allow for treatment at the time of visit. If there are contraindications to either of these medications, such as an allergy, the patient is not eligible for treatment in the clinic and alternative treatment will be prescribed to an outside pharmacy per current guidelines. Treatment of chlamydia requires azithromycin 1 g by mouth in a single dose, and treatment of gonorrhea requires the same azithromycin dose with the addition of ceftriaxone 250 mL by intramuscular injection. This dual treatment of gonorrhea is due to emerging resistance and became an official recommendation by the CDC in 2010.3
Descriptive statistical analysis was performed, and groups were compared. Logistic regression analysis was performed using R Commander (version 3.5.1). Logistic regression analysis was performed using a stepwise model selection including sex, race, age, clinic location, symptoms, collection method, results, and treatment received in the clinic (Table 1).
Seven hundred twenty-two records matching inclusion criteria were reviewed. There were 667 unique patients, with 23 patients returning for 2 visits and 3 patients returning 3 times during the 6-month time frame. Of the 722 patient visits, 14.1% (n = 102/722) tested positive for chlamydia (9.1%; n = 66/722), gonorrhea (3.7%; n = 27/722), or both (1.2%; n = 9/722). Women (n = 487) presented with symptoms 85.2% (n = 415/487) of the time, whereas men (n = 235) presented with symptoms 46.8% (n = 110/235) of the time. Positive results were obtained from 21.3% (n = 50/235) and 10.7% (n = 52/487) men and women, respectively.
During the initial clinic visit, 25.8% of patients (n = 186/722) were treated: 68.8% (n = 128/186) overtreated and 8.2% (n = 44/536) undertreated. In comparison, those treated based on laboratory results were inappropriately treated only if the patient could not be reached to receive treatment (Table 2).
Variables that showed statistical significance to patient receiving appropriate treatment were whether treatment was prescribed at the time of the visit and the patient-collected vaginal swab method of testing. Patients who were treated in the clinic were significantly less likely to be treated appropriately compared with patients who received treatment based on laboratory results (odds ratio, 0.04; confidence interval, 0.02–0.06). Women who self-collected vaginal swabs had significantly lower odds of being treated appropriately than did the reference group of patients who had provider-collected endocervical swabs (odds ratio, 0.04; confidence interval, 0.09–0.80). Although only 22 patients self-collected vaginal swabs during their visit, 22.7% (n = 5/22) had positive results. Zero of the 5 positive patients were treated in the clinic resulting in undertreatment. Three patients were treated in the clinic, but they had negative results (i.e., were overtreated).
This study demonstrated inappropriate treatment as evidenced by undertreatment and overtreatment of chlamydia and gonorrhea in an urgent care setting at the time of the patient's visit. The appropriate management of STIs, such as chlamydia and gonorrhea, in an urgent care setting can be challenging without diagnostic test result guidance, often leading the provider to decide whether to prescribe empiric treatment before the patient leaves. If empiric treatment is not prescribed, yet the patients test positive for chlamydia or gonorrhea with NAAT, there are concerns that the patients have continued to have sex with one or multiple partners, they cannot be reached with the results, or they do not follow up as directed for treatment. These possibilities allow for forward disease transmission. The results from standard NAAT in this study had an average turnaround time of 3 to 4 days. Although there is a lack of literature regarding chlamydia and gonorrhea treatment accuracy in urgent cares, there are similar studies that have been done in emergency department (ED) settings and they face similar challenges.4,10–12
In a chart review study of adolescents and adults aged 13 to 24 years screened in an ED for chlamydia and gonorrhea, an overtreatment rate of 21.6% and an undertreatment rate of 43.4% were identified.12 Factors influencing overtreatment in this study were known STI exposure and presenting genitourinary symptoms, concluding that syndromic management does not lead to accurate treatment.12 Women's symptoms can be explained by other confounding vaginal conditions, such as bacterial vaginosis, trichomonas, vaginal candidiasis, or leukorrhea, which were not evaluated as part of the current study. In addition, undertreatment was found to be problematic in the current study. Fifteen patients were required to return to the clinic for treatment of gonorrhea, as they did not receive empiric treatment at the time of the visit and 2.9% (n = 3/15) were lost to follow-up. Also, in the current study, there is concern that there might not be accurate treatment outcomes equally across sexes based on their presenting symptoms. Because sex was not identified by the logistical regression analysis as a factor to receiving appropriate care, it was not investigated further but would be an area for future research.
Another study found inappropriate treatment of chlamydia and gonorrhea to be problematic at the time of the patient visit, but with implantation of a rapid test in the ED, improvement in clinical management was demonstrated.10 With their rapid test group, there were 0% undertreatment and 23.1% overtreatment of both chlamydia and gonorrhea as compared with 43.8% and 46.7%, respectively, using standard NAAT.10 Having results available during the patient's visit was imperative in reducing antibiotic overuse and ensuring accurate treatment.10 Similarly, a second study showed that POC tests would increase appropriate gonorrhea treatment when compared with NAAT in an ED setting.11 They found, similar to this study, that STI management based on symptoms and clinical judgment alone resulted in 50% of the patients receiving unnecessary treatment.11 Reducing inaccurate treatment through improved diagnostics in ambulatory settings, like urgent care and ED, will not only reduce potential health complications for the patient but also promote antibiotic stewardship.4,10
The CDC has warned of antibiotic resistance among the most common STIs. Gonorrhea has the strongest resistance history, and guidelines are constantly evolving to keep up with this trend. The most recent gonorrhea treatment guideline from the CDC is from 2015 and recommends dual treatment with injectable ceftriaxone plus oral azithromycin, the last remaining treatment option. The dual treatment is important because it ensures cure and prevention of future resistance.3 As recent as 2006, the CDC still had 5 treatment options for gonorrhea; now it has 1.3 The CDC reports that 30% of new gonorrhea infections each year are resistant to at least 1 antibiotic and, in a 2013 report, lists gonorrhea as a top 3 antibiotic resistance threat in the United States.3
The current study also identified that patients who self-collected vaginal swabs at the time of their visit were less likely to be treated appropriately as compared with the reference group of provider-collected endocervical swabs. Only 22 patients had this type of testing collection, which is a small proportion, but the finding was nevertheless significant. The small number is related to only asymptomatic women being allowed to self-collect, thus reflecting a lack of clinical data to drive empiric treatment. Another consideration for the low number of patient-collected vaginal swabs could be lack of provider awareness that vaginal swab specimens, patient or provider collected, are the preferred sample type for chlamydia and gonorrhea testing according to the CDC 2015 sexually transmitted disease treatment guidelines; therefore, they are not offering this collection method to asymptomatic women.13 Specifically, patient-collected vaginal swabs are equivalent in sensitivity and specificity to swabs collected by the provider.13,14 According to the findings from the current study, providers were less likely to treat empirically in the clinic if a patient-collected vaginal swab was obtained. Rationale may be providers are hesitant to treat empirically without a pelvic examination or if they do not collect the swab themselves. This finding has identified a possible gap in knowledge, and education is needed to change this practice.
Limitations existed during this study. The study was done with 4 urgent care clinics within one health system in the Midwest, so generalizability of the study would be limited. It is assumed that testing and infection rates would differ between practice specialties and geographical regions. Data collection was limited to documented information within the patient chart. Patients' symptoms and exposure may have been inconsistently documented. History of STI was not specifically collected and may have been helpful; however, documentation of this may also have been inconsistent.
Chlamydia and gonorrhea are 2 of the most common STIs, and patients are increasingly seeking care for them in urgent care settings; however, with emerging antibiotic resistance and levels of these infections continuing to rise throughout the United States, treatment accuracy is of the utmost importance. Syndromic management leads to inaccurate treatment of chlamydia and gonorrhea at the time of the patient visit. Access to rapid results through POC testing could improve treatment accuracy by promoting antibiotic stewardship and decreasing forward disease transmission.
1. Konz N. IDPH reports rare gonorrhea fatality in Iowa patient. KCIM News
. June 12, 2019: Available at: https://www.1380kcim.com/news/2019/idph-reports-rare-gonorrhea-fatality-in-iowa-patient/
. Accessed October 24, 2019.
2. Centers for Disease Control and Prevention. Chlamydia. Sexually Transmitted Diseases Surveillance 2018. Available at: https://www.cdc.gov/std/stats18/chlamydia.htm
. Updated September 30, 2019. Accessed October 1, 2019.
3. Centers for Disease Control and Prevention. Gonorrhea. Sexually Transmitted Diseases Surveillance 2018. Available at: https://www.cdc.gov/std/stats18/gonorrhea.htm
. Updated July 30, 2019. Accessed October 1, 2019.
4. 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.
5. Abu Raya B, Bamberger E, Kerem NC, et al. Beyond “safe sex”—Can we fight adolescent pelvic inflammatory disease?Eur J Pediatr 2013; 172:581–590.
6. Kozel TR, Burnham-Marusich AR. Point-of-care testing for infectious diseases: Past, present, and future. J Clin Microbiol 2017; 55:2313–2320.
7. Natoli L, Maher L, Shephard M, et al; TTANGO Investigators. Point-of-care testing for chlamydia and gonorrhoea: Implications for clinical practice. PLoS One 2014; 9:e100518.
8. Williams SP, Kinsey J, Carry MG, et al. Get in, get tested, get care: STD services in urban urgent care centers. Sex Transm Dis 2019; 46:648–653.
9. Pearson WS, Tao G, Kroeger K, et al. Increase in urgent care center visits for sexually transmitted infections, United States, 2010–2014. Emerg Infect Dis 2017; 23:367–369.
10. Gaydos CA, Ako MC, Lewis M, et al. Use of a rapid diagnostic for Chlamydia trachomatis
and Neisseria gonorrhoeae
for women in the emergency department can improve clinical management: Report of a randomized clinical trial. Ann Emerg Med 2019; 74:36–44.
11. Huppert JS, Taylor RG, St Cyr S, et al. Point-of-care testing improves accuracy of STI care in an emergency department. Sex Transm Infect 2013; 89:489–494.
12. Anaene M, Soyemi K, Caskey R. Factors associated with the overtreatment and under-treatment of gonorrhea and chlamydia in adolescents presenting to a public hospital emergency department. Int J Infect Dis 2016; 53:34–38.
13. Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 2015; 64(RR-03):1–137.
14. Lunny C, Taylor D, Hoang L, et al. Self-collected versus clinician-collected sampling for chlamydia and gonorrhea screening: A systemic review and meta-analysis. PLoS One 2015; 10:e0132776.