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Serological Screening for Genital Herpes
Evidence Syntheses, No. 149
Investigators: Cynthia Feltner, MD, MPH, Catherine Grodensky, MPH, Charles Ebel, BA, Jennifer Cook Middleton, PhD, Russell P Harris, MD, MPH, Mahima Ashok, PhD, MS, and Daniel E Jonas, MD, MPH.
Author Information and AffiliationsStructured Abstract
Purpose:
To assess the benefits and harms of serologic screening and preventive interventions for genital herpes simplex virus (HSV) infection in asymptomatic adults, adolescents, and pregnant women.
Data Sources:
PubMed/MEDLINE, the Cochrane Library, EMBASE, and trial registries through March 31, 2016 and reference lists of retrieved articles; outside experts; reviewers; and surveillance of literature through October 31, 2016.
Study Selection:
Two investigators independently selected English-language studies using a priori criteria. Eligible studies included randomized, controlled trials (RCTs) of screening or preventive interventions for genital HSV infection, RCTs assessing the benefits or harms of preventive interventions aimed at reducing transmission or future symptomatic episodes of genital herpes, studies evaluating accuracy of serologic screening tests for HSV-2, systematic reviews (and studies published after eligible systematic reviews) evaluating the accuracy of serologic tests or harms of screening, multi-institution antiviral medication pregnancy exposure registries, and trials or observational studies assessing the harms of serologic screening.
Data Extraction:
One investigator extracted data and a second checked accuracy. Two reviewers independently rated quality for all included studies using predefined criteria.
Data Synthesis:
We included 17 studies. No RCTs compared screening with no screening. Eleven studies assessed the accuracy of one or more serologic tests for HSV-2; most of these 11 studies enrolled populations with a high prevalence of HSV-2 (>40%) and did not describe whether participants had current or past symptoms consistent with genital herpes. Ten studies assessing the accuracy of the HerpeSelect® HSV-2 test (n=6,537 participants) provided sufficient data to estimate sensitivity and specificity at the manufacturer’s cutpoint (1.1); pooled estimates of sensitivity and specificity were 99 percent (95% CI, 97 to 100) and 81 percent (95% CI, 68 to 90), respectively. Seven studies (n=5,516 participants) also assessed the accuracy of HerpeSelect at higher cutpoints (ranging from 2.2 to 3.5); pooled estimates of sensitivity and specificity were 95 percent (95% CI, 91 to 97) and 89 percent (95% CI, 82 to 93), respectively. Four studies (n=1,512 participants) evaluated the accuracy of the Biokit HSV-2 Rapid Test; pooled estimates of sensitivity and specificity were 84 percent (95% CI, 73 to 91) and 95 percent (95% CI, 93 to 97), respectively. Use of HerpeSelect at the manufacturer’s cutpoint in a population of 100,000 with a HSV-2 prevalence of 16 percent (the seroprevalence in the general U.S. adult population with unknown symptom status) would result in 15,840 true-positive tests and 15,960 false-positive tests (positive predictive value, 50%). Serologic screening for genital herpes is associated with psychosocial harms, including distress and anxiety related to positive test results. Two RCTs compared preventive antiviral medications with placebo in nonpregnant adults who were HSV-2 seropositive and reported on symptoms consistent with genital herpes over 6 to 8 weeks; these studies found inconsistent results. Two RCTs compared preventive antiviral medications with placebo among serodiscordant couples to prevent HSV-2 transmission; these studies were heterogeneous and found inconsistent results.
Limitations:
Most studies assessing the accuracy of serologic screening tests were conducted in African countries where the prevalence of HSV-2 is much higher than in the United States. The true prevalence of asymptomatic HSV-2 infection in the United States is unknown. We identified no eligible studies that assessed behavioral counseling interventions in adults, adolescents, or pregnant women with asymptomatic or unrecognized genital herpes. Two RCTs assessing preventive antiviral medications in populations with asymptomatic HSV-2 were heterogeneous and followed participants over a short time (6 to 8 weeks). Two RCTs assessing preventive antiviral medications in serodiscordant couples were heterogeneous; one enrolled generally healthy couples who were serodiscordant for both HSV-2 and HIV from African countries.
Conclusions:
Serologic screening tests are associated with a high rate of false-positive results in populations with a HSV-2 prevalence similar to that in the U.S. adult population. Serologic screening for genital herpes is associated with potential psychosocial harms, including distress and anxiety. Current evidence from controlled trials does not establish whether or not preventive antiviral medication for asymptomatic HSV-2 infection has benefit.
Contents
Suggested citation:
Feltner C, Grodensky C, Ebel C, Cook Middleton J, Harris RP, Ashok M, Jonas DE. Serological Screening for Genital Herpes: An Evidence Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 149. AHRQ Publication No. 15-05223-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2016
This report is based on research conducted by the RTI International–University of North Carolina Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (HHSA-290-2012-00015-I, Task Order No. 6). The findings and conclusions in this document are those of the authors, who are responsible for its contents, and do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, (i.e., in the context of available resources and circumstances presented by individual patients).
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
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