Draft Research Plan
Draft Research Plan for Chlamydial and Gonococcal Infections: Screening
This opportunity for public comment expired on March 6, 2019 at 8:00 PM EST
Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. 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.
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.
Draft: Proposed 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 and gonococcal infections in reducing complications of infection and transmission or acquisition of disease, including gonorrhea, chlamydia, and HIV?
- What is the effectiveness of risk stratification methods or alternative screening strategies for identifying persons who are at increased risk for chlamydial and gonococcal infections (such as those who are younger, men who have sex with men)? Screening strategies include cotesting for concurrent sexually transmitted infections, including HIV, or using different screening intervals.
- What is the diagnostic accuracy of anatomic site–specific testing and self-collected swabs for identifying persons with chlamydial and gonococcal infections?
- What are the harms of screening for chlamydial and gonococcal infections (such as labeling, anxiety, false-positive results, false-negative results/reassurance, change in risk behaviors or risk perception)?
Draft: Proposed Contextual Question
The contextual question will not be systematically reviewed and is not shown in the Analytic Framework.
- What is the effectiveness of partner management (such as traditional partner notification and management, expedited partner therapy) in reducing rates of reinfection or acquisition of chlamydial and gonococcal infections?
Draft: Proposed Research Approach
The Proposed 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 (ages ≥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 sexually transmitted infection, including HIV; children (age <13 years); studies in which the majority of participants was comprised of HIV-infected persons or HIV-uninfected persons currently using pre-exposure prophylaxis|
|Interventions||KQs 1, 4: Screening for chlamydial and gonococcal infections
KQ 2: Screening strategies to detect infection, including selective screening of high-risk groups (such as persons who are younger, men who have sex with men, persons with high-risk sexual behavior or high-risk sexual partners), cotesting for concurrent sexually transmitted infections, including HIV; and using different screening intervals
KQ 3: Test methods and approaches to detect chlamydial or gonococcal infections in biological specimens from various anatomical sites (urine, endocervix, urethra, vagina, anus, pharynx)
|No intervention; no screening|
|Comparisons||KQs 1, 2: Screening vs. no screening or alternate screening strategy or methods
KQ 3: Gold standard
|Outcomes||KQ 1: Complications of infection (pelvic inflammatory disease, ectopic pregnancy, infertility, chronic pelvic pain, epididymitis, other clinical outcomes); disease transmission; reproductive, pregnancy-related, and perinatal outcomes
KQ 2: Accuracy of screening strategies
KQ 3: Diagnostic accuracy of anatomic site–specific testing; accuracy of self-collected specimens
KQ 4: Harms from screening (such as labeling, false-negative results, false-positive results, change in risk perception or risk behaviors)
|Intermediate outcomes (outcomes that are not health outcomes, such as eradication of infection, laboratory studies)
|Setting||Primary care and primary care–referable settings (such as correctional settings and community care, such as schools and sexually transmitted infection clinics); emergency departments; military/college intake or entrance settings||Other settings not relevant or referable to primary care|
|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, 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.
Internet Citation: Draft Research Plan: Chlamydial and Gonococcal Infections: Screening. U.S. Preventive Services Task Force. February 2019.