An observational study in Genital Herpes, sponsored by Centers for Disease Control and Prevention. Completed at 3 sites in United States. Open to participants aged 16 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-23.
Sponsored by Centers for Disease Control and Prevention · Observational
The purposes of this study are:
The purposes of this study are:
We will evaluate the assays in diverse populations:
The study will inform the development of testing strategies:
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's enrollment of 2,500 is above the median of 180 across 55 observational studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
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 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.
Sensitivity and Specificity using Western Blot as the Gold Standard test
Time frame: Up to 4 months after initial testing
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
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centers for Disease Control and Prevention