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Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

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ClinicalTrials.gov Identifier: NCT01112956
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : March 23, 2011
Sponsor:
Collaborators:
Massachusetts General Hospital
Johns Hopkins University
New York University School of Medicine
Information provided by:
Centers for Disease Control and Prevention

Study Description
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Brief Summary:

The purposes of this study are:

  • 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.

Condition or disease
Genital Herpes

Detailed Description:

The purposes of this study are:

  • 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.

Study Design
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Study Type : Observational
Actual Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies
Study Start Date : July 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex

Groups and Cohorts
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Group/Cohort
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.
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and Specificity using Western Blot as the Gold Standard test [ Time Frame: Up to 4 months after initial testing ]

Secondary Outcome Measures :
  1. In population with relative low prevalence of HSV-2 infection (e.g. persons <=25 years), whether a combination of tests (i.e. testing algorithm(s)) can increase the positive predictive value to the level of >= 95% [ Time Frame: Up to 4 months after initial testing ]

Biospecimen Retention:   Samples Without DNA
Serum specimens

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will comprise of diverse ethnic and racial populations derived from 3 Health and Human Services Regions and recruited from different type of clinics: 1) STD clinics 2) Prenatal clinic 3) Health clinic for gay men
Criteria

Inclusion Criteria:

  • Men and women 16-55 years of age

Exclusion Criteria:

  • Those who refuse to get tested for HIV
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112956


Locations
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Centers for Disease Control and Prevention
Massachusetts General Hospital
Johns Hopkins University
New York University School of Medicine
Investigators
Principal Investigator: Donna Felsenstein, MD Massachusetts General Hospital
More Information
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Responsible Party: Fujie Xu/Epidemiologist, CDC
ClinicalTrials.gov Identifier: NCT01112956     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-1127
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011

Keywords provided by Centers for Disease Control and Prevention:
HSV-2
HSV-1
Sensitivity
 Specificity
Testing algorithm
Test evaluation

Additional relevant MeSH terms:
Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
 Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female