Note: This draft Recommendation Statement is not the final recommendation of the U.S. Preventive Services Task Force. This draft is distributed solely for the purpose of pre-release review. It has not been disseminated otherwise by the USPSTF. It does not represent and should not be interpreted to represent a USPSTF determination or policy.
This draft Recommendation Statement is based on an Evidence Report that is also available for public comment. To read the accompanying draft Evidence Report on Screening for Gonorrhea and Chlamydia and provide comments, go to http://www.uspreventiveservicestaskforce.org/draftrep2.htm
The USPSTF makes recommendations about the effectiveness of specific clinical preventive services for patients without related signs or symptoms.
It bases its recommendations on the evidence of both the benefits and harms of the service, and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.
The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decisionmaking to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.
This draft Recommendation Statement is available for comment from April 29 until May 26, 2014, at 5:00 PM ET. You may wish to read the entire Recommendation Statement before you comment. A fact sheet that explains the draft recommendations in plain language is available here.
Screening for Chlamydia and Gonorrhea: U.S. Preventive Services Task Force Recommendation Statement
Summary of Recommendation and Evidence
The U.S. Preventive Services Task Force (USPSTF) recommends screening for chlamydia and gonorrhea in sexually active women age 24 years and younger and in older women who are at increased risk for infection.
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men.
This is an I statement.
Go to the Clinical Considerations section for suggestions for practice regarding the I statement.
Chlamydia and gonorrhea are the most commonly reported sexually transmitted infections (STIs) in the United States. In 2011, more than 1.4 million cases of chlamydia were reported to the Centers for Disease Control and Prevention (CDC) (1). Although most identified cases of chlamydial infection are reported, disease incidence is difficult to estimate because most infections are asymptomatic and therefore never diagnosed. The CDC estimates that more than 800,000 persons are infected with gonorrhea in the United States each year, and less than half of these cases are reported (2).
Although chlamydial and gonococcal infections are often asymptomatic in women, these infections may cause cervicitis and complications related to pelvic inflammatory disease (PID) (e.g., ectopic pregnancy, infertility, and chronic pelvic pain). In men, chlamydial and gonococcal infections may lead to symptomatic urethritis and epididymitis. Both types of infection may facilitate HIV transmission (1, 3, 4).
The USPSTF found convincing evidence that screening tests can accurately detect chlamydia and gonorrhea.
Benefits of Early Detection and Intervention or Treatment
The USPSTF found adequate evidence that screening reduces complications of infection in women who are at increased risk for chlamydial or gonococcal infection, with moderate magnitude of benefit.
The USPSTF found inadequate evidence that screening for chlamydia or gonorrhea reduces complications of infection and transmission or acquisition of either disease or HIV in men. The magnitude of benefit is unknown.
Harms of Early Detection and Intervention or Treatment
The USPSTF found adequate evidence that the harms of screening for chlamydia or gonorrhea are small to none.
The USPSTF concludes with moderate certainty that screening for chlamydia and gonorrhea is associated with moderate net benefit in women who are at increased risk for infection, including women age 24 years or younger and older women who are at increased risk for infection.
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men.
Patient Population Under Consideration
This recommendation applies to all sexually active adolescents and adults, including pregnant women.
Assessment of Risk
Age is a strong predictor of risk for both chlamydial and gonococcal infections, with highest infection rates found in women ages 20 to 24 years, followed by women ages 15 to 19 years. Among men, infection rates are highest in those ages 20 to 24 years (1).
Other risk factors for infection include having a new sex partner, more than one sex partner, or a sex partner who has an STI infection; inconsistent condom use; history of previous or coexisting STIs; and exchanging sex for money or drugs. Increased prevalence rates are also found in incarcerated populations, military recruits, and patients receiving care at public STI clinics. There are also racial/ethnic differences in STI prevalence. In 2011, blacks and Hispanics had higher rates of infection compared with whites (1). Clinicians should consider the communities they serve and may wish to consult local public health authorities for guidance on identifying groups at increased risk.
Infection with Chlamydia trachomatis is diagnosed by nucleic acid amplification tests (NAATs), cell culture, direct immunofluorescence, and enzyme immunoassay. NAATs are recommended because their sensitivity and specificity are high and they are approved by the U.S. Food and Drug Administration (FDA) for use on urogenital sites, including male and female urine, as well as clinician-collected endocervical, vaginal, and male urethral specimens. Some NAATs are also approved for use on self-collected vaginal specimens in clinical settings. Rectal and pharyngeal swabs can be collected from persons who engage in receptive anal intercourse, although these sites of collection have not been approved by the FDA (5).
Infection with Neisseria gonorrhoeae can be detected by NAATs using male and female urine and clinician-collected endocervical, vaginal, and male urethral specimens. Some NAATs are also approved for use on self-collected vaginal specimens in clinical settings. Cotesting for chlamydia and gonorrhea can be done using the same specimen (5).
In the absence of studies on screening intervals, a reasonable approach would be to screen patients when risk factors change.
Treatment or Interventions
Chlamydial and gonococcal infections are responsive to treatment with antibiotics. CDC guidelines for sexually transmitted disease (STD) treatment and expedited partner therapy are available at www.cdc.gov/std/treatment/2010/default.htm and www.cdc.gov/std/ept/default.htm.
Posttest counseling is an integral part of management of patients with a newly diagnosed STI. The USPSTF recommends offering, or referral for, high-intensity behavioral counseling for patients with current or recent STIs (www.uspreventiveservicestaskforce.org/uspstf/uspsstds.htm). Posttest counseling can also serve as an educational opportunity for patients who present with STI concerns but test negative for infection. Posttest counseling should address safer sex practices that can reduce disease transmission or reinfection; motivational interviewing strategies can also promote risk-reducing behaviors.
To maximize compliance, the CDC recommends that drug treatment should be dispensed on site. The CDC recommends that all sex partners from the preceding 60 days be evaluated and treated for infection for all patients with chlamydial or gonococcal infection. The CDC also recommends that infected patients be instructed to abstain from sexual intercourse until after they and their sex partners have completed treatment and no longer have symptoms. In the case of a heterosexual partner that cannot be linked to care, the CDC suggests that clinicians consider expedited partner therapy, which allows for the delivery of a drug or drug prescription to the partner by the patient, a disease investigation specialist, or a pharmacy. Because of a high likelihood of reinfection, the CDC also recommends retesting all patients diagnosed with chlamydial or gonococcal infection 3 months after treatment, regardless of whether they believe their partners have been treated.
In pregnant women, retesting to document eradication 3 weeks after treatment is recommended. Pregnant women diagnosed with chlamydial infection in the first trimester should also be retested 3 months after treatment. Adverse outcomes of pregnancy, specifically neonatal ophthalmia, may be prevented with routine topical prophylaxis at delivery. However, prevention of neonatal pneumonia due to chlamydial infection requires prenatal detection and treatment.
Suggestions for Practice Regarding the I Statement
Potential Preventable Burden
Chlamydial infection in men may cause nongonoccal urethritis, epididymitis, and, in rare instances, urethral structures and reactive arthritis. However, asymptomatic urethritis is uncommon. Gonococcal infections in men may lead to symptomatic urethritis, epididymitis, and prostatitis. The majority of urethral infections are often symptomatic, resulting in timely treatment and prevention of serious complications. However, infections at extragenital sites (e.g., pharynx and rectum) are typically asymptomatic. Chlamydial and gonococcal infections may facilitate HIV transmission in men and women (1, 3, 4).
Potential harms of screening for chlamydia or gonorrhea include false-positive or false-negative results, as well as labeling and anxiety associated with positive results.
According to the CDC, STDs in the United States are associated with an annual cost of almost $16 billion (6). Among the nonviral STIs, chlamydia is the most costly infection, with total costs of $516.7 million (range, $258.3 to $775 million). Gonococcal infections are associated with total costs of $162.1 million (range, $81.1 to $243.2 million) (7).
In 2008, estimated direct lifetime costs per case of chlamydial infection were $30 (range, $15 to $45 [in 2010 U.S. dollars]) in men and $364 (range, $182 to $546) in women. Similarly, gonococcal infections were associated with direct costs of $79 (range, $40 to $119) in men and $354 (range, $182 to $546) in women (7).
A review of health care claims of 4,296 male and female patients presenting for general medical or gynecologic examinations from 2000 to 2003 found that a large proportion of patients with high-risk sexual behaviors did not receive STI/HIV testing during these clinic visits. According to one review of diagnostic billing codes for patients with high-risk sexual behaviors, men were significantly less likely than women to be tested for chlamydia (20.7% of men vs. 56.9% of women) and gonorrhea (20.7% of men vs. 50.9% of women), although they were more likely to be tested for HIV (79.3% of men vs. 38.8% of women) and syphilis (39.1% of men vs. 27.6% of women) (8).
Other Approaches to Prevention
The USPSTF has issued recommendations on screening for other STIs, including hepatitis B, genital herpes, HIV, and syphilis. The USPSTF has also issued recommendations on behavioral counseling to prevent STIs. These recommendations can be found at www.uspreventiveservicestaskforce.org.
The CDC provides information about STDs, including chlamydia and gonorrhea (available at www.cdc.gov/std/default.htm).
The CDC's recommendations for STD prevention include clinical prevention guidance (available at www.cdc.gov/std/treatment/2010/clinical.htm) and patient prevention information (available at www.cdc.gov/std/prevention/default.htm).
Canadian guidelines on STIs are available at www.phac-aspc.gc.ca/std-mts/sti-its/cgsti-ldcits/index-eng.php#toc.
The USPSTF suggests cotesting for chlamydia and gonorrhea, which can be done using the same test specimen
Research Needs and Gaps
Studies evaluating the effectiveness of different screening strategies for identifying individuals at increased risk for infection, cotesting for concurrent STIs, and different screening intervals are needed to inform practice guidelines. Studies evaluating the effectiveness of screening asymptomatic men to reduce the consequences infection and transmission to sexual partners are needed. Identification of subgroups for whom screening may be effective is a high priority. Possibilities include men who have sex with men, sexually active males younger than age 24 years, and males from high prevalence communities. No studies provided data about potential adverse effects of screening for any of the population groups.
Burden of Disease
Chlamydia and gonorrhea are the most commonly reported STIs in the United States (1). In 2011, more than 1.4 million cases of chlamydial infection were reported to the CDC, corresponding to a rate of 457.6 cases per 100,000 persons (1). However, the true incidence of chlamydial infection is difficult to accurately estimate because most infections are asymptomatic and therefore undetected. In 2011, the rate of chlamydial infection in women (648.9 cases per 100,000 females) was more than double the rate in men (256.9 cases per 100,000 males), with the majority of cases occurring in women ages 15 to 24 years (1).
In 2011, more than 300,000 cases of gonococcal infection were reported to the CDC, corresponding to a rate of 104.2 cases per 100,000 persons (1). The majority of infections occurred in women ages 15 to 24 years and men ages 20 to 24 years. The infection rate was higher in women than men (108.9 cases per 100,000 females vs. 98.7 cases per 100,000 males) (1).
Scope of Review
The USPSTF commissioned a systematic review (5, 9) that included studies published since previous USPSTF reviews of these topics (10, 11). Included studies had to be applicable to clinical settings and practices in the United States, as determined by the similarity of participants, health care services, and available screening tests. Conditions of interest included chlamydial and gonococcal infections in asymptomatic patients. The key questions are described in the systematic review (5, 9).The USPSTF also considered evidence from its previous recommendations and reviews.
Accuracy of Screening Tests
The USPSTF found convincing evidence that available screening tests can accurately diagnose chlamydial and gonococcal infections. Eight fair-quality (12–19) and two good-quality (20, 21) diagnostic accuracy studies indicate that screening for chlamydia and gonorrhea with NAATs is highly accurate for specimens from various anatomical sites for women and men (5).
For chlamydia, sensitivity for NAAT specimens collected from genitourinary sites ranged from 86% to 100% in studies without major limitations. In women, NAATs showed little variation in sensitivity across endocervical and clinician- or self-collected vaginal and urine specimens. In men, testing of urine specimens was slightly more sensitive than testing of urethral specimens. For gonorrhea, NAAT sensitivity ranged from 91% to 100% in studies without major limitations. NAATs performed slightly better in male samples than female samples. For both chlamydia and gonorrhea, specificity was high across all specimens and tests (5).
Effectiveness of Early Detection and Treatment
Previous USPSTF reviews identified two randomized, controlled trials (RCTs) of the effectiveness of screening for chlamydia for the prevention of PID in nonpregnant women at increased risk for infection. In one RCT, a strategy of identifying, testing, and treating women at increased risk for cervical chlamydial infection was associated with reduced incidence of PID (relative risk [RR], 0.44 [95% CI, 0.20 to 0.90]) (22). In another RCT, one-time home-based screening was associated with lower incidence of chlamydial infection (RR, 0.45 [95% CI, 0.24 to 0.84]) and PID (RR, 0.50 [95% CI, 0.23 to 1.08]) compared with physician-based screening after 1 year of followup (23). This study was conducted in 1,761 female high school students in Denmark. Although this study rated as poor-quality because of significant loss to followup, it was retained in the previous review because its findings were consistent with the other study.
The current USPSTF review identified another good-quality RCT of 2,529 sexually active young women recruited from universities and colleges in the United Kingdom (24). Women who were screened and treated for chlamydial infection were less likely to develop PID after 1 year of followup than women whose testing was deferred (RR, 0.65 [95% CI, 0.34 to 1.22]). Among asymptomatic women, 0.6% in the screening group versus 1.6% in the deferred group developed PID during followup (RR, 0.39 [95% CI, 0.14 to 1.08]) (5, 9).
The USPSTF previously found fair evidence that treatment of chlamydial infection during pregnancy is associated with improved outcomes for both infants and mothers (25). The USPSTF previously reviewed large cohort studies of screening at the first prenatal visit in pregnant women at increased risk for infection (26, 27). These studies found that treatment of chlamydial infection, when compared to lack of treatment or treatment failure, was associated with significantly lower rates of preterm delivery, early rupture of membranes, and infants with low birth weight. No subsequent studies met inclusion criteria for the current or most recent USPSTF review (5, 9).
The USPSTF found little direct evidence on the effectiveness of screening for chlamydial infection in men or low-risk women. The USPSTF found that the overall prevalence of chlamydial infection in the general population varies widely, depending on age and other risk factors (28). In men, chlamydial infection may cause epididymitis, but serious complications are uncommon. Screening and treating young men at increased risk for infection may reduce the incidence of chlamydial infection; however, the USPSTF found no published prospective trials of the effect of routine screening in men, or comparison with the strategy of screening women and treating their male partners (5, 9, 25, 29). The USPSTF found no studies on the benefits of screening women, including pregnant women, who are not at increased risk for infection. The optimal criteria for screening women who are not at increased risk for infection depend on local disease burden and available resources.
The USPSTF found no studies of the effectiveness of screening for gonorrhea in either the current or previous USPSTF reviews (5). The USPSTF previously found indirect evidence of the benefits of early detection and treatment, including the substantial prevalence of asymptomatic infection, availability of accurate screening tests and effective treatments, and high morbidity of untreated gonorrhea in women (26). Gonococcal infections in women are frequently asymptomatic (30). Asymptomatic men and women comprise an important reservoir of new infection. In women, 10% to 20% of untreated infections lead to PID (31), which may lead to hospitalization, surgery, chronic pelvic pain, ectopic pregnancy, and/or infertility.
Though untested in controlled trials, early detection and treatment of gonorrhea in pregnant women at increased risk for infection may decrease morbidity from infection-related obstetric complications. The primary rationale for screening all pregnant women is prevention of ophthalmia neonatorum. However, the USPSTF recognizes the low infection prevalence in pregnant women who are not at increased risk for infection and the effectiveness of universal ocular prophylaxis in newborns. Accordingly, the USPSTF found small net benefit of screening for gonorrhea in pregnant women who are not at increased risk for infection.
The USPSTF found little direct evidence on the effectiveness of screening for gonorrhea in men or low-risk women (5, 9, 26, 32). The USPSTF previously found that screening for gonorrhea in all sexually active adults is inefficient because of the low infection prevalence in these groups (26, 32). Moreover, the majority of genital gonococcal infections in men are symptomatic, resulting in potentially more timely clinical presentation and leading to diagnosis and treatment that prevents serious complications (33).
For both chlamydia and gonorrhea, the USPSTF found no studies that compared the effectiveness of different screening strategies in asymptomatic individuals, or the effectiveness of sampling from various anatomic sites, cotesting for concurrent STIs, or using different screening intervals (5).
Potential Harms of Screening and Treatment
Eight fair-quality (12–19) and two good-quality (20, 21) diagnostic accuracy studies (described earlier) indicated that screening tests for chlamydia and gonorrhea had low false-positive and false-negative results across all NAATs and specimen types. The current USPSTF review (5) identified several published studies that describe testing-related psychosocial harms (e.g., anxiety). However, these studies did not meet inclusion criteria because they included symptomatic individuals and focused on reactions to positive test results, rather than screening. No studies that addressed other harms met inclusion criteria (e.g., labeling or screening-related anxiety).
Estimate of Magnitude of Net Benefit
The USPSTF found direct evidence that screening for chlamydia in women at increased risk for infection is associated with moderate benefit, including reduced incidence of PID in nonpregnant women and improved infant and maternal outcomes in pregnant women. The USPSTF noted the existence of shared risk factors for both gonococcal and chlamydial infections, as well as the availability of effective methods for the detection and treatment of both infections. Based on these factors, the USPSTF found indirect evidence of moderate benefit of screening for gonorrhea in women at increased risk for infection. The USPSTF found that screening for chlamydia and gonorrhea is associated with harms that are small to none. Accordingly, the USPSTF concluded with moderate certainty that screening for chlamydial and gonococcal infections is associated with moderate net benefit in this population.
The USPSTF found inadequate evidence of benefit of screening for chlamydial or gonococcal infection in men, though harms from screening are small to none. The USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydial and gonococcal infection in men.
How Does Evidence Fit With Biological Understanding?
Chlamydial and gonococcal infections are often asymptomatic in women. Untreated infections may progress to PID-related complications, such as chronic pelvic pain, ectopic pregnancy, or infertility. Infections may also be transmitted to sex partners and unborn children. Accurate screening tests and effective antibiotic treatments are available for both chlamydia and gonorrhea.
Chlamydial and gonococcal infections in men are more likely to cause symptoms that lead to diagnosis and treatment, and serious complications are less common. In the absence of empiric evidence that screening in men reduces disease transmission to women, the USPSTF concluded that the benefits of screening men are unknown.
Update of Previous USPSTF Recommendations
This updated recommendation combines, reaffirms, and simplifies the USPSTF's previous recommendations on screening for chlamydia and gonorrhea.
In 2007, the USPSTF recommended screening for chlamydia in all sexually active women age 24 years or younger, as well as in older women who are at increased risk for infection. The USPSTF recommended against screening for chlamydia in women age 25 years or older who are not at increased risk. The USPSTF found insufficient evidence to assess the balance of benefits and harms of screening for chlamydia in men.
In 2005, the USPSTF recommended screening for gonorrhea in all sexually active women (including pregnant women) who are at increased risk for infection. The USPSTF found insufficient evidence to recommend for or against routine screening for gonorrhea in men who are at increased risk and pregnant women who are not at increased risk. The USPSTF also recommended against routine screening for gonorrhea in men and women who are at low risk for infection.
Recommendations of Others
The CDC recommends annual screening for chlamydia in all sexually active women age 25 years or younger and in older women with specific risk factors (e.g., a new sex partner or multiple sex partners), as well as screening for gonorrhea in sexually active women at increased risk for infection (e.g., younger than age 25 years). The CDC does not recommend routine screening for chlamydia and gonorrhea in the general population. It recommends that clinicians consider screening for chlamydia in sexually active young men in high-prevalence settings (33).
The CDC recommends annual screening for chlamydia and gonorrhea in men who have sex with men, based on exposure history, with more frequent screening in populations at highest risk. The CDC recommends screening for chlamydia and gonorrhea upon intake in juvenile detention or jail facilities in adolescent and adult women age 35 years and younger. It also recommends screening for gonorrhea in high-risk pregnant women and screening for chlamydia in all pregnant women at the first prenatal visit. The CDC recommends retesting in the third trimester in pregnant women with continued risk for infection and in those who test positive at their first prenatal visit (33).
The American Congress of Obstetricians and Gynecologists (ACOG) recommends testing for chlamydia and gonorrhea in sexually active women age 25 years or younger (34). It also recommends testing for chlamydia in women older than age 25 years who have risk factors (e.g., a new sex partner or multiple sex partners). ACOG recommends testing for gonorrhea in asymptomatic women at high risk for infection (e.g., women with prior gonorrhea infection, other STIs, new or multiple sex partners, inconsistent condom use, commercial sex work, or illicit drug use).
The American Academy of Pediatrics and the American Academy of Family Physicians are currently updating their recommendations.
The Canadian guidelines on STIs recommend screening for chlamydia in all sexually active males and females younger than age 25 years, with retesting at 6 months after treatment in infected patients. Canadian guidelines recommend screening for chlamydia and gonorrhea at the first prenatal visit and again during the third trimester in pregnant women who test positive or are at increased risk for infection (35).
Table 1: What the Grades Mean and Suggestions for Practice
Table 2: Levels of Certainty Regarding Net Benefit
|Level of Certainty*||Description|
|High||The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies.|
|Moderate||The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by factors such as:
As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.
|Low||The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of:
More information may allow an estimation of effects on health outcomes.
*The U.S. Preventive Services Task Force defines certainty as "likelihood that the USPSTF assessment of the net benefit of a preventive service is correct." The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.
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AHRQ Publication No. 13-05184-EF-2
Current as of April 2014
U.S. Preventive Services Task Force. Screening for Chlamydia and Gonorrhea: Draft Recommendation Statement. AHRQ Publication No. 13-05184-EF-2. http://www.uspreventiveservicestaskforce.org/draftrec2.htm