Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2
- Conditions
- Genital Herpes
- Registration Number
- NCT01112956
- Lead Sponsor
- Centers for Disease Control and Prevention
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2500
- Men and women 16-55 years of age
- Those who refuse to get tested for HIV
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity using Western Blot as the Gold Standard test Up to 4 months after initial testing
- Secondary Outcome Measures
Name Time Method 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% Up to 4 months after initial testing
Trial Locations
- Locations (3)
John Hopkins University
🇺🇸Baltimore, Maryland, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States