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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Johns Hopkins University | OTHER |
| NYU Langone Health | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity using Western Blot as the Gold Standard test | Up to 4 months after initial testing |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Donna Felsenstein, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| Massachusetts General Hospital |
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| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Serum specimens
| Boston |
| Massachusetts |
| 02114 |
| United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D007154 | Immune System Diseases |