Kerns, Jennifer L. MD, MPH*; Jones, Heidi E. PhD, MPH†; Pressman, Emilee J. MPH†; Fratarelli, Leigh Ann MD, MPH†; Garth, Janet MPH†; Westhoff, Carolyn L. MD, MSc†
Over 1.2 million chlamydia infections in the United States were reported to the Centers for Disease Control and Prevention (CDC) in 2008,1 although the estimated number of annual infections is much higher.2 Eight times as many infections are reported among women aged 15 to 24 years as compared with all women,1 and the prevalence among women aged 18 to 26 is estimated to be 4.2%.3 Untreated chlamydial infection can lead to pelvic inflammatory disease, chronic pelvic pain, and infertility,4–6 and among women aged 15 to 24 years, it accounts for nearly $250 million in direct medical costs each year.7 Most reinfections are the result of resuming relationships with untreated partners, and a number of studies have addressed the importance of effective partner treatment.8–11
Patient referral, providing the patient with information on where the partner can be tested and treated, is not a uniformly successful strategy, resulting in only 30% to 55% of male patients' partners12 and 14% to 31% of female patients' partners receiving treatment.13,14 Expedited partner therapy (EPT) involves prescribing medication to the partner without an intervening examination. Its effectiveness in decreasing reinfection from sexually transmitted infections has been evaluated in 6 randomized controlled trials,15–20 4 of which demonstrated fewer reinfections when EPT was used.16,17,19,20 Although a clinical visit by the partner remains the ideal way to deliver high-quality care, including treatment and testing for other infections, EPT is an appropriate alternative and is supported by the CDC, American College of Obstetricians and Gynecologists, and American Medical Association for treating the partners of patients with chlamydia.21
Although the legal status of EPT varies by state, it is expressly permitted or not expressly prohibited in three-quarters of states22 and is employed by many providers.23 New York State recently passed legislation that allows for EPT for the treatment of chlamydia (Measure A 8730-C). Although the efficacy of EPT has been shown in randomized controlled trials,16,17,19,20 its implementation and effectiveness outside the research setting are less described. We conducted a retrospective cohort study of all women testing positive for chlamydia at a New York City clinic that adopted this approach in 2002 to assess how often EPT was used, what patient-level factors were associated with provision of EPT, and the association between EPT and reinfection.
MATERIALS AND METHODS
The Family Planning Clinic is a part of the New York Presbyterian Hospital Ambulatory Care Network based at the Columbia University Medical Center and serves women in northern Manhattan and the Bronx. As part of the clinic's quality assurance program, the paper and electronic medical records of all women testing positive for chlamydia at the Family Planning Clinic between 2004 and 2005 were reviewed for appropriate treatment. These women were identified from a clinic log used for reporting chlamydia cases to the New York City Department of Health and Mental Hygiene (NYC DOHMH). The present analysis uses an anonymized version of the data and was deemed exempt from ethical review by Columbia University's institutional review board.
Given the evidence from randomized controlled trials that EPT could be employed as an effective partner treatment strategy, the Family Planning Clinic adopted EPT in 2002 as a treatment strategy for partners of women diagnosed with chlamydia. All providers at the clinic are trained to address partner treatment in the context of a suspected or confirmed case of chlamydia. Preprinted clinical forms help ensure that providers are utilizing a partner notification and/or treatment strategy. Providers routinely inquire about numbers of partners within the last 3 months. All patients are routinely offered “patient referral” as well as EPT. Although EPT combined with a partner clinic visit is the preferred strategy, the partner treatment approach is ultimately determined by the clinician after consultation with the patient. Thus, the strategies utilized include (1) patient referral with EPT, (2) patient referral only, (3) EPT only, and (4) nothing. The last strategy is employed only when patients refuse both referral and EPT, or when they have no contact with the partner(s). All women with chlamydial infection are counseled to return to the clinic for a test of reinfection in 3 months. The clinic has no active procedures in place to ensure the patients return.
Chart Review: Baseline and Treatment Characteristics
As part of the quality assurance process, we abstracted information on patient characteristics and clinical services rendered at the index visit. For most patients, the index visit was the day of the positive chlamydia test. A few patients had tested positive for chlamydia in the days before the visit at an outside location (emergency room, outside clinic), and had been told to seek treatment at the clinic. Demographic and reproductive characteristics included age, gravity, parity, contraceptive use, and condom use. Partner characteristics included the number of current partners (defined as partners in the last 3 months), number of partners in the past 12 months, and time with the main partner. Other clinical information included presenting symptoms, presence or absence of pelvic inflammatory disease, and whether the patient was tested for human immunodeficiency virus and syphilis. The routine use of standard templates in the medical record led to substantially complete data for the variables of interest. Patient treatment and partner treatment strategies were obtained from the treatment visit. Providers are prompted by a template to indicate what method of partner treatment they are utilizing.
Electronic Record: Reinfection
An electronic database captures and reports all laboratory tests and logs all visits anywhere within the Columbia University Medical Center system, including inpatient, emergency room, and outpatient visits. The date of the initial infection was confirmed using this electronic record. Each woman's electronic record was searched from the date of the original infection until December 15, 2007 to identify dates and results of all subsequent chlamydia tests. To validate reinfection rates, we sent a list of patients stratified by partner treatment plan to the NYC DOHMH in order to identify repeat positive chlamydia cases within 4 months of the index test (allowing 1 extra month for reporting). The NYC DOHMH reported aggregate data on the number of reinfections reported in each of the partner treatment groups. All chlamydia testing was done with a nucleic acid amplification test, Aptima Combo 2 Assay (Gen-Probe Inc., San Diego, CA). All cases of chlamydial infection that were accompanied by either gonorrheal infection or pelvic inflammatory disease were excluded from the analysis.
As part of the quality assurance objective, provision of EPT to women treated for chlamydia from 2004 to 2005 was assessed as the first outcome. We described demographic, reproductive, relationship, and clinical characteristics associated with receiving EPT. Age and time with current partner were analyzed as continuous variables. Age was also analyzed as a dichotomous variable to explore whether teens (<19) were more or less likely than their older counterparts to receive EPT. Other patient characteristics were analyzed as dichotomous variables, and unadjusted odds ratios (ORs) with 95% confidence intervals (CIs) are reported.
We used multivariable logistic regression to analyze factors associated with provision of EPT. We made the a priori decision to include age and number of current partners (dichotomized to 1 or more than 1) in the model because providers may have altered their decision to provide EPT to women on the basis of these characteristics. We included any other variables significantly associated with EPT provision in the unadjusted analysis. We also analyzed factors associated with reinfection at 3 months and 1 year after treatment among women who were retested within that time period. Because of small numbers, we report only unadjusted analysis.
The largest decrease in reinfection reported in the literature with EPT is 23% to 13% for gonorrhea and chlamydia combined.17 Schillinger et al.19 reported a more modest decrease in reinfection from 15% to 12% for chlamydial reinfection only. With an α of 0.05 and a sample size of 473, we had 89% power to detect a difference of 10%, but only 18% power to detect a difference of 3%. The data were analyzed with Statistical Package for Social Sciences version 16.0 (SPSS Inc, Chicago, IL).
In 2004 and 2005, 499 women were diagnosed with chlamydia at the Family Planning Clinic. All but 8 were cotested for gonorrhea. Fourteen charts were unable to be located and 12 subjects were coinfected with gonorrhea or were diagnosed with pelvic inflammatory disease. Our analysis reflects the 473 subjects with only chlamydia and for whom data were available. Of the 473 patients who tested positive for chlamydia, 466 (99%) were seen and treated (median time to treatment, 12 days; interquartile range, 7–19 days). Nearly two thirds were treated within 2 weeks and 88% were treated within 4 weeks. A minority reported experiencing any symptoms of discharge, pruritus, vaginitis, or dyspareunia (105/466 or 22.5%) at the index visit.
The average age of the population of women testing positive for chlamydia was 21.8 years (Table 1). Less than half were parous. Over half of the women reported only one sexual partner in the past year, and nearly all reported having only one current partner. At the index visit, just under one-quarter received emergency contraception and over half were tested for human immunodeficiency virus.
Of the 466 women who were treated, 36 (7.7%) had no information recorded on partner treatment and 18 (3.9%) reported that their partner had already been treated. EPT was provided to 323 women (69.3%). Nearly half of them were given instructions for patient referral (n = 226). Of the 89 women who did not receive EPT, nearly two-thirds received partner referral (n = 58).
In the unadjusted analysis, gravid and parous women were more likely to have received EPT (OR, 1.8; 95% CI, 1.1–2.9 and OR, 1.9; 95% CI, 1.1–3.1; respectively) (Table 1). Being age 20 or above was associated with 1.6 times higher odds of receiving EPT (95% CI, 1.0–2.5). After adjusting for age and number of current partners, no variables were significantly associated with receiving EPT. Parity was not included in the model as it was highly correlated with age.
Retesting and Reinfection
Most women had at least 1 follow-up test within the study period (85%, n = 397). A total of 40% (n = 189) were retested within 3 months and 74% (n = 343) were retested within 1 year after treatment. Of the 397 women who had a follow-up test, 67 (17%) had a reinfection with chlamydia by the end of follow-up. Among those who were retested within 3 months, 9 (4.8%) reinfections occurred, and among those retested within 1 year, 39 (11.4%) reinfections occurred. An additional 19 reinfections occurred after 1 year.
The proportions of women who were retested at 3 months and 1 year differed according to whether they had received EPT. Those receiving EPT were more likely to be retested at 3 months (58.8% vs. 46.0%, P = 0.09) and at 1 year (75.9% vs. 70.8%, P = 0.3). When women were followed for the duration of the study period, that difference became minimal (86.1% vs. 84.3%, P = 0.7). No baseline characteristics were significantly associated with reinfection at 3 months (Table 2). EPT was associated with slightly higher odds of being reinfected within 3 months (OR, 1.6; 95% CI, 0.2–13.7). Condom use was significantly associated with decreased odds of reinfection at 1 year (OR, 0.5; 95% CI, 0.2–0.9).
Validating Reinfection Rates With the DOHMH
The DOHMH reported slightly more reinfections than were identified by searching the electronic Columbia University Medical Center database. Of the 323 subjects who received EPT, 8 reinfections were identified at 3 months after treatment using electronic records, compared to 12 reinfections identified by the DOHMH. Among women who did not receive EPT (n = 89), 1 reinfection at 3 months was identified using electronic records, compared to 3 identified by the DOHMH. Using DOHMH measures of reinfections, women who received EPT had virtually the same odds of being reinfected at 3 months as women who did not receive EPT (OR, 1.1; 95% CI, 0.3–5.1).
In this observational study of EPT implementation for chlamydial infection among women, we found that most women received EPT (69%). Although providers in the Family Planning Clinic are encouraged to provide EPT, the decision of how to treat the partner is a clinical decision. None of the patient-level characteristics that we were able to abstract from the medical charts emerged as predictors of EPT provision. At least 2 possible reasons may explain this finding. First, EPT provision may have been determined by characteristics that were not recorded in the charts. No data were available on type of relationship (casual or serious) or marital status. Patients with casual partners may have little to no contact with the partner, a situation in which providers would likely not use EPT. Willingness to take the medication may also be related to relationship type, and would potentially sway the provider's decision to offer EPT. Second, the data recorded may not have been accurate. In this study, very few women reported having multiple partners. As our population may be more monogamous than others, it is also possible that women underreported current and past partners. Underreporting could have been the result of patients providing socially desirable answers during the clinical encounter or having a different understanding of the term “partner.” We also were not able to evaluate characteristics of patients who were offered EPT but refused to accept it.
The overall risk of reinfection in this study, 14% (n = 67), is similar to that reported in a recent systematic review that found a median of 13.9% chlamydial reinfections.24 Our reinfection risk at 3 months and 1 year were slightly lower than those reported in the systematic review, i.e., 4.8% and 11.4% versus 8.4% and 14.7%, respectively.24 Our lower risks may be attributable to not all patients being retested, or not retested within the same medical system. However, the systematic review also found that risk of reinfection did not vary by proportion retested.24
Younger age is consistently associated with higher risk of reinfection in the literature, though that was not observed in this study. No clear trend emerged between age and risk of reinfection. Differential retesting of older women does not explain our results as the mean age of those retested and the whole population are the same. Condom use was the only characteristic associated with a lower risk of reinfection. No difference in chlamydia reinfection was seen between women who received EPT and those who did not. Our lack of an association differs from that seen in randomized controlled trials16,17,19,20 and is likely attributable to the observational nature of the study. Only 40% of women were retested within 3 months after treatment, and although they did not differ by characteristics we measured (other than likelihood to have received EPT), they may have differed by characteristics that we were not able to measure. Relationship status, interim partners between treatment and retesting, and patient and partner compliance with treatment and abstinence recommendations are some potential confounders that were not measured. It is possible that those in less stable relationships were more likely to receive EPT, which could explain in part why EPT did not decrease reinfection. However, our limited data and small numbers preclude us from making this conclusion.
The strengths of this study include abstracting data from a clinic where templates are routinely used to record information from the patient encounter. As a result, the data we sought were substantially available through those templates. Another strength is our effort to validate our outcome by cross-checking reinfection at 3 months with the DOHMH records. We found that we captured only 60% (9 of 15) of the reinfections reported to the DOHMH; that is to say, 40% of subjects were retested outside of the medical center system and had their results reported to the DOHMH.
These 2 strengths also illustrate 3 of the limitations of the study. First, because we were limited to data in the medical record, we were not able to measure all variables that may have been related to both EPT provision and risk of reinfection. Partner and relationship characteristics, patient treatment compliance, and partner treatment compliance are all important characteristics that may have acted as confounders. By not measuring them, we cannot know the extent of the bias in how and why patients were given and/or accepted EPT versus another partner treatment strategy. Just as important, we cannot know the extent of the bias introduced by differential retesting. Furthermore, by not controlling for these unmeasured characteristics, we may have missed an association between EPT and reinfection. Given the limitations of this study, the findings may not be generalizable to other sexually transmitted disease clinics.
Nearly all women diagnosed with chlamydia at this clinic were successfully treated and most women received EPT as a partner treatment strategy. However, compliance with the recommendation to be retested in 3 months was poor (40%). EPT did not appear to dissuade patients from being retested, as those retested within 3 months were more likely to have received EPT than those not retested (76% vs. 65%, P < 0.01). Given the evidence for persistently high reinfection rates after chlamydial infection, clinics should focus efforts on how to increase the proportion of patients retested at 3 months. The ideal strategy for increasing follow-up within 3 months is unclear, and may differ on the basis of clinic type, patient population, and available resources. Sending a reminder postcard is one such intervention that has been studied in a New York City sexually transmitted disease clinic.25 The authors concluded that while retesting increased, there was no decrease in detecting reinfections, though a lower background rate of reinfection was observed at the same time. Moreover, they concluded that sending reminder postcards is resource intensive and have not adopted it as a strategy. Although this study found no decrease in reinfection with EPT, EPT remains an important strategy for treating partners. Further efforts to address the high reinfection rate after initial chlamydial infection should address strategies to improve compliance with the recommendation for retesting within 3 months.
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