Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 2500

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • John Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• Men and women 16-55 years of age

Exclusion Criteria:

• Those who refuse to get tested for HIV

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and Specificity using Western Blot as the Gold Standard test	Up to 4 months after initial testing

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Collaborators: Johns Hopkins University; Massachusetts General Hospital; NYU Langone Health
• Investigators: Principal Investigator: Donna Felsenstein, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: October 13, 2009
• First Submitted That Met QC Criteria: April 28, 2010
• First Posted (Estimate): April 29, 2010

Study Record Updates

• Last Update Posted (Estimate): March 23, 2011
• Last Update Submitted That Met QC Criteria: March 22, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Sensitivity; Specificity; HSV-2; HSV-1; Testing algorithm; Test evaluation
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Herpes Simplex; Herpes Genitalis
• Other Study ID Numbers: CDC-NCHHSTP-1127