Genital HerpesNCT01112956
Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2
An observational study of Genital Herpes, run by Centers for Disease Control and Prevention at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Genital Herpes
- How many people
- 2,500 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Men and women 16-55 years of age
Who cannot join
- Those who refuse to get tested for HIV
Trial locations and contacts
3 sites in 1 country.
United States3 sites
John Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
New York University School of Medicine
New York, New York, 10016
About this study
Official title: 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.
Read the 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.
- Conditions
- Genital Herpes
- Keywords
- HSV-2, HSV-1, Sensitivity, Specificity, Testing algorithm, Test evaluation
- Medical subject headings
- Herpes Genitalis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity using Western Blot as the Gold Standard test
Measured: 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%
Measured: Up to 4 months after initial testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital HerpesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Donna Felsenstein, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112956
- Sponsor's protocol ID
- CDC-NCHHSTP-1127
- Status last verified
- Mar 2011
- First submitted
- 13 Oct 2009
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2: Development of Testing Strategies
- ClinicalTrials.gov ID
- NCT01112956
- Acronym / sponsor ID
- CDC-NCHHSTP-1127
- Conditions
- Genital Herpes
- Keywords
- HSV-2, HSV-1, Sensitivity, Specificity, Testing algorithm, Test evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Massachusetts General Hospital, Johns Hopkins University, NYU Langone Health
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Men and women 16-55 years of age
Key exclusion criteria (1 listed)
- Those who refuse to get tested for HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and Specificity using Western Blot as the Gold Standard test
Time frame: Up to 4 months after initial testing
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Felsenstein, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Herpes, run by Centers for Disease Control and Prevention at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity using Western Blot as the Gold Standard test (time frame: Up to 4 months after initial testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2011.