Added: Bejamin Garris - Date: 13.10.2021 07:33 - Views: 44748 - Clicks: 8073
The questions are depicted by linkages that relate interventions and outcomes. A dashed line indicates health outcomes that follow an intermediate outcome. HSV indicates herpes simplex virus. Importance Genital herpes simplex virus HSV infection is a prevalent sexually transmitted infection. Vertical transmission of HSV can lead to fetal morbidity and mortality. Objective To assess the evidence on serologic screening and preventive interventions for genital HSV infection in asymptomatic adults and adolescents to support the US Preventive Services Task Force for an updated recommendation statement.
Surveillance for new evidence in targeted publications was conducted through October 31, Study Seeking a woman hsv2 24 35 English-language randomized clinical trials RCTs comparing screening with no screening in persons without past or current symptoms of genital herpes; studies evaluating accuracy and harms of serologic screening tests for HSV-2; RCTs assessing preventive interventions in asymptomatic persons seropositive for HSV Data Extraction and Synthesis Dual review of abstracts, full-text articles, and study quality; pooled sensitivities and specificities of screening tests using a hierarchical summary receiver operating characteristic curve analysis when at least 3 similar studies were available.
Main Outcomes and Measures Accuracy of screening tests, benefits of screening, harms of screening, reduction in genital herpes outbreaks. No RCTs compared screening with no screening. Serologic screening for genital herpes was associated with psychosocial harms, including distress and anxiety related to positive test. in both populations were heterogeneous and inconsistent. Conclusions and Relevance Serologic screening for genital herpes is associated with a high rate of false-positive test and potential psychosocial harms. Evidence from RCTs does not establish whether preventive antiviral medication for asymptomatic HSV-2 infection has benefit.
Many patients experience s and symptoms during primary infection and recurrences, but some may have mild or Seeking a woman hsv2 24 35 symptoms. The true prevalence of asymptomatic HSV-2 infection is unknown; prevalence estimates rely on serologic test and are not confirmed with Western blot.
In theory, screening to identify unrecognized HSV-2 infection followed by counseling, antiviral treatment episodic or suppressiveor both could prevent transmission and reduce symptoms and shedding. The full evidence report also provides additional information about the proposed methods for key question KQ 7 focused on the association between subclinical genital HSV-2 viral shedding and health outcomesadditional background and contextual information about genital herpes in the United States, and a list of studies that were excluded during the full-text review phase of the literature search.
Figure 1 shows the analytic framework and KQs that guided the review. Search strategies are listed in eMethods in the Supplement.
We searched for unpublished literature in ClinicalTrials. To supplement electronic searches, Seeking a woman hsv2 24 35 lists of pertinent articles and suggested citations from reviewers were reviewed. We conducted ongoing surveillance after March through article alerts and targeted searches of high-impact journals to identify major studies published in the interim that may affect the conclusions or understanding of the evidence and related USPSTF recommendation.
The last surveillance was conducted on October 31, Two investigators independently reviewed titles, abstracts, and full-text articles to determine eligibility using prespecified criteria eTable 1 in the Supplement. Disagreements were resolved by discussion. English-language studies of immunocompetent adults or adolescents, including pregnant women, were included. Only studies rated as good or fair quality were included. For all KQs, studies of persons without symptoms or a clinical history of genital herpes were eligible, as were studies of asymptomatic partners of persons with known genital herpes ie, discordant couples.
For the overarching question on direct evidence that screening improves health outcomes KQ1only randomized clinical trials RCTs comparing groups that were screened with groups that were not screened were included. Quiz Ref ID For KQ2 accuracy of serologic testswe included studies of FDA-approved serologic tests Seeking a woman hsv2 24 35 HSV-2 that reported accuracy compared with the Western blot, which has been used as a reference standard in studies assessing commercially available serologic tests in the United States.
Eligible populations could be symptomatic, asymptomatic, or a combination of both. For KQ3 harms of screeningwe included trials, systematic reviews, and observational studies assessing the harms of screening in asymptomatic populations with no prior diagnosis of genital herpes, with or without a comparison group. For studies assessing benefits or harms of preventive medications in asymptomatic populations KQ4 through KQ6RCTs comparing FDA-approved oral antiviral medications for the suppression of recurrent genital herpes acyclovir, famciclovir, or valacyclovir with placebo were eligible.
RCTs of behavioral counseling interventions eg, education or counseling; partner notification; barrier protection; or combinations of these components were also eligible. For studies assessing the harms of antiviral medications in pregnant women KQ6bmulti-institution antiviral medication pregnancy exposure registries were eligible. Eligible outcomes included reduced rates of symptomatic episodes and transmission including measures of HSV-2 seroconversion.
For KQ5b effectiveness of interventions in pregnant womeneligible outcomes also included rates of neonatal HSV infection and reduced rates of symptomatic genital herpes at delivery. For KQ4 effects of antiviral medication on subclinical HSV-2 sheddingwe included any outcome measure of subclinical HSV-2 shedding eg, percentage of days with any shedding Seeking a woman hsv2 24 35.
For each included study, one investigator extracted information about de, population, tests or treatments used, and outcomes, and a second investigator reviewed for completeness and accuracy. Two independent investigators assessed the quality of each study as good, fair, or poor, using predefined criteria developed by the USPSTF and adapted for this topic eTables in the Supplement.
Individual study quality ratings are provided in the Supplement eTables Findings for each question were summarized in tabular and narrative form. To determine whether meta-analyses were appropriate, the clinical and methodological heterogeneity of the studies was assessed following established guidance. For KQ2 the only KQ with sufficient s of similar studies for quantitative synthesespooled sensitivities and specificities for each type of serologic test were calculated using a hierarchical summary receiver operating characteristic HSROC curve analysis when at least 3 similar studies were available.
Separate models were developed for each type of serologic test, and separate analyses were conducted for HerpeSelect using the manufacturer-recommended Seeking a woman hsv2 24 35 for test positivity and for higher cutpoints reported in the literature to determine whether accuracy is improved with using higher cutpoints. The metandi program in Stata version 14 12 was used to conduct all quantitative analyses. Seventeen included studies with a total of participants range, and reported in 19 publications were identified Figure 2.
Key Question 1a. Does serologic screening for HSV-2 or combined testing for HSV-1 and HSV-2 in asymptomatic nonpregnant adults and adolescents reduce future symptomatic episodes and transmission of genital herpes? Key Question 1b.
Key Question 2. What is the accuracy of serologic screening for HSV-2 in asymptomatic adults, adolescents, and pregnant women? Most studies enrolled participants from 1 or more African countries; 3 were set in the United States, 131718 and 1 enrolled participants from multiple countries Argentina, Costa Rica, Korea, Mexico, Nigeria, Thailand, and Vietnam.
All 11 studies compared the Focus HerpeSelect HSV-2 enzyme-linked immunosorbent assay with Western blot and used a test cutpoint value of 1. Seven studies also assessed higher test cutpoints to boost specificity ranging from 2. Studies handled equivocal or indeterminate test in various ways, which may contribute to heterogeneity in estimates of test accuracy eTable 8 in the Supplement. Key Question 3a. Key Question 3b. Characteristics and outcomes of the 2 included fair-quality studies are shown in eTable 10 in the Supplement.
Participants were recruited from clinical settings STI, maternal and infant care, family medicine, and research clinics and completed in-depth interviews on their experience of HSV-2 diagnosis. The authors concluded that participants exhibited strong emotional and psychological responses to their serologic diagnoses of HSV-2, while observing that some of these responses were time limited. Key Question 4. How effective are oral antiviral medications in reducing genital HSV-2 viral shedding in asymptomatic adolescents, adults, and pregnant women? Study characteristics are shown in Table 3.
One RCT reported a statistically ificant reduction in viral shedding outcomes, and the other did not Table 3. In addition, the validity and reliability of daily self-swab to ascertain viral shedding is unclear, potentially contributing to measurement bias.
Key Question 5a. How effective are preventive medications and Seeking a woman hsv2 24 35 counseling interventions in reducing future symptomatic episodes and transmission of genital herpes in asymptomatic nonpregnant adults and adolescents? Key Question 5b. How effective are preventive medications and behavioral counseling interventions in reducing neonatal HSV infection and symptomatic episodes of genital herpes at delivery in pregnant women?
Two RCTs comparing daily suppressive antiviral medication with placebo also reported viral shedding outcomes and were described in KQ4. Both reported on incidence of genital herpes symptoms Table 3. Symptoms were ascertained by self-report not using a validated questionnaire over a relatively short duration weeks. One study enrolled participants who had HSV serologic testing as part of their clinical care 26 ; may not be applicable to those who screen positive but are not seeking testing for HSV infection. Two RCTs compared the benefit of daily suppressive antiviral medication with placebo for preventing genital herpes transmission between HSV-2—serodiscordant heterosexual couples; one measured outcomes at 8 months 2829 and the other at 12 to 24 months Table 3.
The 2 trials found conflicting Table 3. In the RCT assessing valacyclovir, fewer HSV-2—susceptible partners in the valacyclovir group had Seeking a woman hsv2 24 35 HSV-2 infection than partners randomized to placebo over 8 months 0. At follow-up median, 18 monthsthe of susceptible partners with seroconversions was not statistically different between the acyclovir group 40 and placebo group 28which indicated seroincidence of 5.
Key Question 6a. What are the harms of preventive medications and behavioral counseling interventions for reducing future symptomatic episodes and transmission of genital herpes in asymptomatic nonpregnant adults and adolescents? Key Question 6b. What are the harms of preventive medications and behavioral counseling interventions for reducing neonatal HSV infection and symptomatic episodes of genital herpes at delivery in asymptomatic pregnant women?
This review did not identify any eligible studies directly assessing the benefits or harms of serologic screening for HSV-2 compared with no screening. Therefore, the literature that might establish an indirect chain of evidence from multiple questions that link screening to health outcomes KQ2 through KQ7 was reviewed.
Table 4 provides a summary of findings in this evidence review. Estimates for specificity varied and were imprecise, without a clear explanation for the observed heterogeneity. Potential explanations for false-positive serologic test include cross-reactivity with HSV-1 or other virusesrecent seroconversion, geographic variability in HSV-2 strain variants, and laboratory error.
At higher cutpoints, estimates of sensitivity and specificity from 8 studies in Africa were still imprecise. Quiz Ref ID There was evidence from 2 uncontrolled observational studies that detection of unexpected HSV-2 by screening is associated with potential Seeking a woman hsv2 24 35 harms, including anxiety, worry, and distress. Other potential harms of serologic screening include false-positive that lead to psychosocial distress and costs of confirmatory testing.
Quiz Ref ID The estimates of the accuracy of serologic tests are generally applicable to populations with a higher prevalence of HSV-2 infection than general primary care populations in the United States. Use of HerpeSelect in a population with lower prevalence, similar to that of US adults, would greatly increase the of false-positive test .
If sensitivity were unchanged, screening a lower-prevalence population would Seeking a woman hsv2 24 35 the of false-negative testalthough the negative predictive value would change little. It is possible, however, that the sensitivity of the screening tests could be lower in a lower-prevalence population, owing to such factors as lower antibody levels, thus increasing the of false-negative per persons tested. The direction of these changes with prevalence would be similar regardless of which cutpoints were used.
There was limited evidence evaluating preventive interventions for asymptomatic adults who screen positive for HSV No studies enrolled pregnant women or adolescents, and none assessed behavioral counseling interventions. Two RCTs total of participants assessed the benefit of preventive antiviral medications for reducing HSV-2 viral shedding and symptomatic occurrences among adults seropositive for HSV-2 who reported no prior genital herpes symptoms.
Evidence from these 2 trials does not allow an accurate estimate of the benefit of preventive antiviral medications for improving health outcomes. The 2 trials differed in several ways. They assessed different medications valacyclovir and acyclovirrecruited from different sources, and used different tests to establish HSV-2 infection. Both assessed outcomes over a short time weeks and relied on self-report to ascertain symptom occurrence.
This duration is likely inadequate to evaluate whether antiviral medications reduce symptom incidence among populations who have been asymptomatic. were inconsistent and imprecise; 1 trial found benefit for valacyclovir compared with placebo for reducing viral shedding and symptom occurrences, 26 and the other found no statistically ificant differences between groups. Similarly, the 2 RCTs assessing preventive antiviral medications for reducing HSV-2 transmission between serodiscordant partners were heterogeneous and found inconsistent.
One enrolled immunocompetent couples from primarily industrialized countries, 28 while the other enrolled couples discordant for both human immunodeficiency virus and HSV-2 from sub-Saharan Africa. One trial found benefit for valacyclovir compared with placebo for reducing symptomatic HSV-2 infection and HSV-2 seroconversion in the susceptible partner; however, the magnitude of benefit for symptom reduction was modest, and were imprecise 0.
One trial assessed harms of medications; adverse events were similar between groups randomized to valacyclovir and placebo. This review had limitations. Studies were required to compare an FDA-approved currently available serologic screening test with Western blot. We did not evaluate other comparisons, such as a serologic test compared with a viral polymerase chain reaction swab or culture or with another commercially available serologic test, to determine concordance. We limited the assessment to studies enrolling people with no current or prior symptoms and found only 2 trials.
For people with frequent symptomatic recurrences of genital herpes more than 4 episodes per yearantiviral medications have been shown to reduce the frequency of recurrences; however, the magnitude of effect is uncertain, and the quality of evidence is low. A Cochrane review published in evaluated the efficacy of antiviral medications acyclovir, famciclovir, and valacyclovir to suppress genital herpes outbreaks in nonpregnant adults 34 ; 22 trials were included, and the risk of bias was considered high for half of the studies and unclear for the other half. Serologic screening for genital herpes is associated with a high rate of false-positive test and potential psychosocial harms.
Author Contributions: Dr Feltner had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Critical revision of Seeking a woman hsv2 24 35 manuscript for important intellectual content: Feltner, Grodensky, Ebel, Harris, Ashok, Jonas. Statistical analysis: Feltner. Obtained funding: Feltner, Jonas. Administrative, technical, or material support: Grodensky, Ebel, Middleton, Jonas.
Supervision: Feltner, Jonas. AHRQ had no role in study selection, quality assessment, or synthesis. AHRQ staff provided project oversight; reviewed the report to ensure that the analysis met methodological standards, and distributed the draft for peer review. Otherwise, AHRQ had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript findings. Additional Information: A draft version of the full Seeking a woman hsv2 24 35 report underwent external peer review from 4 content experts Rhoda A.
Comments from reviewers were presented to the USPSTF during its deliberation of the evidence and were considered in preparing the final evidence review. It did not undergo additional peer review after submission to JAMA.Seeking a woman hsv2 24 35
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Genital Herpes - CDC Fact Sheet (Detailed)