Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Johns Hopkins University
New York University School of Medicine
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01112956
First received: October 13, 2009
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

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
Genital Herpes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Sensitivity and Specificity using Western Blot as the Gold Standard test [ Time Frame: Up to 4 months after initial testing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum specimens


Enrollment: 2500
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   16 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Massachusetts General Hospital
Johns Hopkins University
New York University School of Medicine
Investigators
Principal Investigator: Donna Felsenstein, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Fujie Xu/Epidemiologist, CDC
ClinicalTrials.gov Identifier: NCT01112956     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-1127
Study First Received: October 13, 2009
Last Updated: March 22, 2011
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 15, 2014