Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

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.

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Key information

Conditions

Genital Herpes Communicable Diseases DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Herpes Genitalis Herpes Simplex Herpesviridae Infections Hypersensitivity Immune System Diseases Infections Male Urogenital Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

John Hopkins University, Baltimore, Maryland, United States

About this study

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:

STD clinic population
Men who have sex with men, with high prevalence of HIV infection
Pregnant women

The study will inform the development of testing strategies:

Combine commercial tests to optimize positive predict value (PPV) and negative predict value (NPV)
Increase cutoff values to increase PPV
Understand factors associated with false positive results that may include HSV-1 infection, pregnancy status, HIV infection, and age/race etc.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and women 16-55 years of age

Exclusion criteria

Those who refuse to get tested for HIV

Treatment and study plan

Primary outcomes

Sensitivity and Specificity using Western Blot as the Gold Standard test

Time frame: Up to 4 months after initial testing

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

Johns Hopkins University
Massachusetts General Hospital
NYU Langone Health

Registry information

Official study title

Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Apr 29, 2010
Registry last updated: Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed