Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2
NCT ID: NCT01112956
Last Updated: 2011-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2500 participants
OBSERVATIONAL
2009-07-31
2011-02-28
Brief Summary
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* To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2);
* To assess the sensitivity and specificity of the commerical assays using HSV-2 western blot as the "gold standard" in a diverse patient population;
* To develop testing strategies and recommendations for screening asymptomatic populations for HSV-2.
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Detailed Description
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* To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2);
* To assess the sensitivity and specificity of the commerical assays using HSV-2 western blot as the "gold standard" in a diverse patient population;
* To develop testing strategies and recommendations for screening asymptomatic populations for HSV-2.
We will evaluate the assays in diverse populations:
1. STD clinic population
2. Men who have sex with men, with high prevalence of HIV infection
3. Pregnant women
The study will inform the development of testing strategies:
1. Combine commercial tests to optimize positive predict value (PPV) and negative predict value (NPV)
2. Increase cutoff values to increase PPV
3. Understand factors associated with false positive results that may include HSV-1 infection, pregnancy status, HIV infection, and age/race etc.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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STD clinic patients
Patients attending sexually transmitted Disease clinics. If the initial testing result reported to the patient is confirmed by the Western Blot test, no follow-up specimens will be collected. If the initial testing result reported to the patient is different from the result by the Western Blot test, patients will be asked to provide a follow-up specimen 3-4 months after initial testing.
No interventions assigned to this group
Pregnant women
Women recruited from prenatal clinic. A follow-up visit may or may not needed depending on results from the initial test and Western blot test.
No interventions assigned to this group
Men who have Sex with men (MSM)
Men recruited from a clinic for MSM with high risk for HIV infection. A follow-up visit may or may not needed depending on results from the initial test and Western blot test.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
55 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Johns Hopkins University
OTHER
NYU Langone Health
OTHER
Centers for Disease Control and Prevention
FED
Responsible Party
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CDC
Principal Investigators
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Donna Felsenstein, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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John Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
New York University School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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CDC-NCHHSTP-1127
Identifier Type: -
Identifier Source: org_study_id
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