Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

Centers for Disease Control and Prevention (CDC)

Status: Completed

Conditions: Genital Herpes

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01112956

CDC-NCHHSTP-1127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 patients

Sex: All

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women 16-55 years of age

Exclusion criteria

• Those who refuse to get tested for HIV

Trial design

2,500 participants in 3 patient groups

STD clinic patients

Description:

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

Description:

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)

Description:

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.