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Final Research Plan

Final Research Plan for Chlamydial and Gonococcal Infections: Screening

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from February 7 until March 6, 2019 at 5:00 p.m., ET.

Analytic Framework

The analytic framework depicts the relationship between the populations, interventions, outcomes, and harms of screening for chlamydia and gonorrhea. The far left of the framework describes the target population as asymptomatic adolescents and adults, including those who are pregnant. To the right of the population is an arrow that represents chlamydia or gonorrhea screening, including screening strategies for populations at increased risk (key question 2) and test methods at specific anatomic sites (key question 3), that leads to the population with chlamydial or gonococcal infection. An arrow below key questions 2 and 3 represents harms or adverse effects of screening for chlamydia or gonorrhea (key question 4). To the right of the population with chlamydial or gonorrheal infection a dotted line arrow represents treatment and leads to the three clinical health outcomes, including reduced complications of chlamydial or gonococcal infection; reduced transmission or acquisition of infection; and reduced adverse maternal, fetal, or infant outcomes. The clinical health outcome of reduced transmission or acquisition of infection is an intermediate outcome, as noted by the rounded edges of the box. A dotted line arrow to the right of reduced transmission or acquisition of infection leads to reduced adverse maternal, fetal, or infant outcomes, depicting an association. Arrows with dotted lines acknowledge the relationship between infection and outcomes, but will not be directly addressed in this systematic review. An overarching arrow that extends from the screened population to the clinical health outcomes symbolizes the effectiveness of screening (key question 1).

Key Questions to Be Systematically Reviewed

  1. In sexually active, asymptomatic adolescents and adults, including those who are pregnant, what is the effectiveness of screening for chlamydial or gonococcal infections in reducing complications of infection and transmission or acquisition of disease, including gonorrhea, chlamydia, and HIV?
  2. What is the accuracy of risk stratification methods or alternative screening strategies for identifying persons at increased risk for chlamydial or gonococcal infections (such as younger persons or men who have sex with men)? Screening strategies include testing for concurrent sexually transmitted infections, including HIV, or using different screening intervals.
  3. What is the diagnostic accuracy of anatomic site–specific testing and collection methods for identifying persons with chlamydial or gonococcal infections?
  4. What are the harms of screening for chlamydial or gonococcal infections (such as labeling, anxiety, false-positive results, false-negative results/reassurance, or changes in risk behaviors or risk perception)?

Contextual Questions

The contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the prevalence rate of chlamydial or gonococcal infections (and concurrent HIV infection) in partners of patients who test positive for chlamydial or gonococcal infections?
  2. What is the effectiveness of partner services (such as traditional partner services or expedited partner therapy) in reducing rates of reinfection or acquisition of chlamydial or gonococcal infections in the index patient?

Research Approach

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).

  Included Excluded
Populations Asymptomatic adults (age ≥18 years) and adolescents (ages 13 to <18 years); pregnant persons Patients with symptoms of chlamydial or gonococcal infections; patients with current or recent diagnosis of any acute sexually transmitted infection; patients undergoing management for HIV infection; children (age <13 years); studies in which the majority of participants is comprised of persons infected with HIV or persons not infected with HIV and currently using pre-exposure prophylaxis
Interventions KQs 1, 4: Screening for chlamydial or gonococcal infections

KQ 2: Screening strategies to detect infection, including selective screening of high-risk groups (such as younger persons, men who have sex with men, persons with high-risk sexual behaviors, or persons with high-risk sexual partners); testing for concurrent sexually transmitted infections, including HIV; using different screening intervals

KQ 3: Test methods and approaches (such as self- vs. clinician-collected) to detect chlamydial or gonococcal infections in biological specimens from various anatomical sites (such as urine specimens and samples from the endocervix, urethra, vagina, anus, or pharynx)

No intervention; no screening
Comparisons KQs 1, 2: Screening vs. no screening or alternate screening strategies or methods

KQ 3: Gold standard (nucleic acid amplification testing) or other reference standard (if study does not use nucleic acid amplification testing), specific to anatomic site or sites where gold standard sample is collected, when reported

No comparison; testing methods not cleared or approved by the U.S. Food and Drug Administration
Outcomes KQ 1: Complications of infection (such as pelvic inflammatory disease, ectopic pregnancy, infertility, chronic pelvic pain, or epididymitis); infection transmission or acquisition, including gonorrhea, chlamydia, and HIV; reproductive, pregnancy-related, and perinatal outcomes

KQ 2: Accuracy of screening strategies

KQ 3: Diagnostic accuracy of testing at a specific anatomic site; accuracy of self- vs. clinician-collected specimens

KQ 4: Harms from screening or not screening (such as labeling, false-negative results, false-positive results, or changes in risk perception or risk behaviors)

Intermediate outcomes (outcomes that are not health outcomes, such as eradication of infection or laboratory studies)
Settings U.S.-relevant primary care and primary care–referable settings (such as correctional settings, community care, schools, sexually transmitted infection clinics, and family planning settings); emergency departments; military or college intake or entrance settings Other settings not relevant or referable to primary care in the United States
Study Design All KQs: Good-quality systematic reviews

Benefits: Randomized, controlled trials; controlled observational trials

Harms: Randomized, controlled trials; controlled observational trials; uncontrolled observational trials

Uncontrolled observational trials (except for evidence on screening harms), case reports, small uncontrolled observational trials, and case studies
Study Quality Fair- and good-quality studies based on USPSTF criteria Poor-quality studies

Abbreviations: HIV = human immunodeficiency virus, KQ = key question, USPSTF = U.S. Preventive Services Task Force.

Response to Public Comment

The draft Research Plan was posted on the USPSTF Web site from February 7, 2019 to March 6, 2019. Recurrent themes from comments included the public health and population effects of screening; issues around stratification and identification of risk and risk behavior; screening strategies, including targeted vs. universal screening; and cotesting or coinfection. In response to these comments, the USPSTF clarified terminology around diagnostic accuracy, anatomic site–specific testing, and the included risk groups and risk behaviors; clarified the gold standard for testing as nucleic acid amplification testing (or other standards reported by studies if nucleic acid amplification testing is not used); and clarified the inclusion of all persons age 13 years and older, including those who are pregnant, and the exclusion of persons infected with HIV or persons not infected with HIV and currently using pre-exposure prophylaxis. The USPSTF made no changes to the scope of the review. Evidence for chlamydial and gonorrheal infection will be presented separately and each will have separate recommendation grades.

Current as of: May 2019

Internet Citation: Final Research Plan: Chlamydial and Gonococcal Infections: Screening. U.S. Preventive Services Task Force. May 2019.
https://www.uspreventiveservicestaskforce.org/Page/Document/final-research-plan/chlamydial-and-gonococcal-infections-screening

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