Patients who were presumptively treated received treatment for their infection(s) an average of 9.9 (SD, 5.2) days earlier than patients who were treated based on test results regardless of clinic type. There were no notable variations in the average days to treatment when stratified by patient characteristics (data not shown). For the 4660 patients with positive tests who were not presumptively treated, 31.9% received appropriate treatment within 7 days, 63.8% within 14 days, and 73.6% within 30 days. Thus, 26.4% of patients with positive tests who were not presumptively treated remained without evidence of treatment after 30 days; 31.0% of males and 23.4% of females in STD clinics, and 73.8% of males and 22.6% of females in FP clinics.
Appropriate follow-up treatment within 30 days varied by patient characteristics (Tables 1-2). Patients younger than 19 years had lower levels of appropriate follow-up treatment within 30 days than those in any other age group in both STD clinics and FP clinics. While comprised of relatively small numbers, men with positive tests who attended FP clinics were the least likely to receive appropriate treatment within 30 days. Fifty-nine of 110 men with positive tests had no record of treatment within 30 days (aPR, 0.7; 95% CI, 0.6–0.8). Patients diagnosed at larger volume (≥1360 visits per year) STD clinics were treated presumptively more frequently (57.1% vs. 48.8%), but were equally likely to have been treated within 30 days (87.8% vs. 87.5%). In contrast, patients diagnosed at larger volume FP clinics were slightly less likely to be treated presumptively (8.1% vs. 11.0%), and they remained less likely to have a record of treatment within 30 days (71.4% vs. 81.2%; aPR, 0.96; 95% CI, 0.9–1.0).
A subanalysis of 13 of the largest volume clinics found that test positivity ranged from 10% to 22%. Of patients with positive test results, 51% were treated presumptively (range, 28–62%), and 13% of patients with negative test results were treated presumptively (range, 6–19%). In STD clinics, 57% of patients with positive tests were presumptively treated compared to only 8% in FP clinics (16% and 3% of patients with negative tests were presumptively treated in these two settings respectively). After stratifying by clinic type, the frequency of presumptive treatment was not correlated with patient volume, clinic geographic region, or CT/GC test positivity rate (data not shown).
The average CT/GC positivity rate in our clinic population, based on patient visits, was 13% (17% in STD clinics, 7% in FP clinics). We found that just over half (54%) of all persons with positive CT/GC test results were treated presumptively with an appropriate antibiotic therapy in STD clinics, which is on the lower end of the range reported by previous studies conducted in emergency departments (54%–68%).6,9,10 Only 10% of persons testing positive in FP clinics were presumptively treated, possibly reflecting differences in the characteristics of patients presenting to these settings. Similar to previous research, we found that men were more likely than women to be treated presumptively for CT/GC in both STD and FP clinics, possibly because of a propensity for infected men to present with symptoms.9–11,13
Although only 10% of the patients with negative laboratory tests for CT/GC were treated presumptively in our study (15% in STD clinics, 3% in FP clinics), our estimate of the number of people presumptively treated for CT/GC who ended up having negative test results was 66% (57% in STD clinics, 81% in FP clinics), similar to the 68% observed in the other recent study of presumptive treatment in a public STD clinic in Florida.12 We chose not to focus on overtreatment in this analysis, as it was impossible to determine based on the data available. For example, our “over-treated” category would include patients treated for recent STD exposure who tested negative but had incubating infections. Furthermore, as only CT/GC test results were available, we were not able to account for other symptomatic urogenital infections such as atypical urethritis which may be treated with the same antibiotics as CT. A study in a Washington, DC, STD clinic found 31.2% of men had atypical urethritis.14 This may partly explain why males were treated presumptively more often than females in our study.
There is some concern that presumptive treatment for CT/GC may result in over-treatment and potentially lead to antibiotic resistance, adverse effects, and waste of limited health department resources. Although presumptive treatment for CT/GC in this clinic population resulted in some apparent over-treatment, it may be warranted as untreated patients did not always return quickly, or at all, for follow-up treatment, thus increasing the risk of under-treatment, potential for medical complications, and further transmission of infection. Among infected patients not presumptively treated, 26% remained untreated after 30 days (23% of females and 33% of males). Our findings are comparable to previous studies, in which 20% of STD clinic patients15 and 8% to 32% of ED patients remained untreated.8
We believe that the threat of antibiotic resistance due specifically to presumptive treatment is small, particularly when applied to public health department settings which dispense only a fraction of these very common antibiotics. One recent ecological study did not find an association between population-level prescribing rates of clinically relevant antibiotics and Neisseria gonorrhoeae antimicrobial drug susceptibility.16 There is limited evidence suggesting that frequent azithromycin use might play a role in decreasing susceptibility to azithromycin (as measured by an increase in minimum inhibitory concentrations),17 but the same has not been demonstrated for ceftriaxone. Overall, evidence for an association between antimicrobial drug use and gonococcal susceptibility is lacking at this time, and while this is an important consideration in the provision of presumptive treatment, more research is needed.
The financial cost of presumptive treatment in Virginia's health department clinics was just US $2 per patient for dual therapy with ceftriaxone and azithromycin in 2016. The cost of treating uninfected patients is far outweighed by the benefit from prompt treatment and the reduced need for follow-up clinic visits. Indeed, several previous studies have suggested that mass treatment may be an economically and medically feasible approach in selected clinic settings.5,18,19
Further research is needed to see if presumptive treatment reduces the likelihood of partner notification. Patients may be less likely to tell a partner about a presumed infection than a diagnosed infection. Bowen20 reported that patients treated presumptively were less likely to receive their test results than patients who were not treated presumptively at an STD clinic (46% vs. 83%).
This study has some limitations. The lack of information about patient symptoms and exposure (ie, sexual history) status in our administrative dataset is a major limitation of this study, as we were missing key information about provider rationale in deciding whether to treat presumptively. All procedures performed during the clinic visits were captured by this data system, but results of physical examinations and other medical observations were not. Similarly, we defined presumptive treatment as treatment administered on the same day as specimen collection for CT/GC laboratory testing, not based on actual clinician documentation. In terms of our measurement of under-treatment, we did not look beyond a 30 day window after testing, and it is possible that patients received treatment at other (non–health department) facilities. However, we believe this scenario to be unlikely, as treatment services were provided at no cost for patients who returned to health department clinics. The main exception might be clients who subsequently developed symptoms prompting immediate medical care.
The emergence of reliable rapid assays for CT/GC screening would dramatically change the current presumptive treatment dynamic for many patients, although it would not influence presumptive treatment decisions for recently exposed partners who may be incubating infections. Some such rapid tests already exist, but long test completion times (about 90 minutes) and high costs still limit their utility in acute care settings.21–24 As new more efficient rapid tests are developed, our ability to accurately diagnose and treat STDs in real time will be greatly improved. Until then, we need to carefully consider both the positive and negative implications of presumptive treatment for sexually transmitted infections in various clinical settings, especially considering the high fraction of patients visiting health department clinics in this study that appear to have gone untreated. Promoting presumptive treatment for CT/GC at the time of testing may help reduce this occurrence among clinic populations with a high likelihood of loss to follow-up.
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