Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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