Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2
This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Johns Hopkins University
New York University School of Medicine
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01112956
First received: October 13, 2009
Last updated: March 22, 2011
Last verified: March 2011
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Purpose
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.
| Condition |
|---|
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Genital Herpes |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies |
Resource links provided by NLM:
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- Sensitivity and Specificity using Western Blot as the Gold Standard test [ Time Frame: Up to 4 months after initial testing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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% [ Time Frame: Up to 4 months after initial testing ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Serum specimens
| Enrollment: | 2500 |
| Study Start Date: | July 2009 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
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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.
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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.
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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:
- STD clinic population
- Men who have sex with men, with high prevalence of HIV infection
- Pregnant women
The study will inform the development of testing strategies:
- Combine commercial tests to optimize positive predict value (PPV) and negative predict value (NPV)
- Increase cutoff values to increase PPV
- Understand factors associated with false positive results that may include HSV-1 infection, pregnancy status, HIV infection, and age/race etc.
Eligibility| Ages Eligible for Study: | 16 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| 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
Criteria
Inclusion Criteria:
- Men and women 16-55 years of age
Exclusion Criteria:
- Those who refuse to get tested for HIV
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112956
Locations
| United States, Maryland | |
| John Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New York | |
| New York University School of Medicine | |
| New York, New York, United States, 10016 | |
Sponsors and Collaborators
Massachusetts General Hospital
Johns Hopkins University
New York University School of Medicine
Investigators
| Principal Investigator: | Donna Felsenstein, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Fujie Xu/Epidemiologist, CDC |
| ClinicalTrials.gov Identifier: | NCT01112956 History of Changes |
| Other Study ID Numbers: | CDC-NCHHSTP-1127 |
| Study First Received: | October 13, 2009 |
| Last Updated: | March 22, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centers for Disease Control and Prevention:
|
HSV-2 HSV-1 Sensitivity |
Specificity Testing algorithm Test evaluation |
Additional relevant MeSH terms:
|
Herpes Genitalis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Genital Diseases, Male Genital Diseases, Female Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013