Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

NCT01112956 | Completed

• 1 other identifier: CDC-NCHHSTP-1127
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 3

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.

Conditions

Genital Herpes

Keywords

HSV-2; HSV-1; Sensitivity; Specificity; Testing algorithm; Test evaluation

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity using Western Blot as the Gold Standard test

  Up to 4 months after initial testing

Secondary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Men and women 16-55 years of age

You may not qualify if:

• Those who refuse to get tested for HIV

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Massachusetts General Hospital: collaborator
• Johns Hopkins University: collaborator
• NYU Langone Health: collaborator

Study Sites (3)

John Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum specimens

MeSH Terms

Conditions

Herpes Genitalis; Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Donna Felsenstein, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: April 29, 2010
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: March 23, 2011

Record last verified: 2011-03

Locations

US (3)