Clinical trial NCT01112956: Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2
Official title: Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genital Herpes
Keywords: HSV-2
HSV-1
Sensitivity
Specificity
Testing algorithm
Test evaluation
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Massachusetts General Hospital
name: Johns Hopkins University
name: NYU Langone Health
First posted: 2010-04-29
Enrollment: 2500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

* Men and women 16-55 years of age

Exclusion Criteria:

* Those who refuse to get tested for HIV

Primary outcomes:
measure: Sensitivity and Specificity using Western Blot as the Gold Standard test
timeFrame: Up to 4 months after initial testing
Secondary outcomes:
measure: 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%
timeFrame: Up to 4 months after initial testing
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: Massachusetts General Hospital
name: Donna Felsenstein, MD
role: PRINCIPAL_INVESTIGATOR
References: