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.
Key Questions to Be Systematically Reviewed
- 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?
- 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.
- What is the diagnostic accuracy of anatomic site–specific testing and collection methods for identifying persons with chlamydial or gonococcal infections?
- 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)?
The contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- 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?
- 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?
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).
|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.
Internet Citation: Final Research Plan: Chlamydial and Gonococcal Infections: Screening. U.S. Preventive Services Task Force. May 2019.