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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AI161943-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of this study is to evaluate infection detection and treatment initiation rates for syphilis and HIV before and after integration of the Chembio DPP® HIV-Syphilis rapid POC test into an ongoing Emergency Department (ED) testing program and to determine whether dual rapid testing improves early initiation of HIV therapy in pregnant patients with newly identified HIV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chembio HIV/Syphilis rapid POC test plus standard of care lab based HIV/Syphilis testing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chembio HIV/Syphilis rapid Point of Care (POC) test | Diagnostic Test | Participants will undergo dual rapid HIV/syphilis testing by fingerstick using the Chembio DPP® HIV-Syphilis System. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that tested for HIV | Baseline | |
| Number of participants that tested for syphilis | Baseline | |
| Number of participants that tested positive for syphilis and who receive same-visit treatment initiation with Benzathine Penicillin G according to the Centers for Disease Control and Prevention (CDC) 2021 Guidelines. | about 15 minutes after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that tested positive for HIV who start antiretroviral therapy (bictegravir/emtricitabine/tenofovir alafenamide) | about 15 minutes after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Stafford, M.D., M.S., M.P.H. | Contact | (713) 500-6412 | Irene.Stafford@uth.tmc.edu | |
| Robin L Beach | Contact | (713) 500-5940 | Robin.L.Beach@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Irene Stafford, M.D., M.S., M.P.H. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| Laboratory-based HIV and syphilis testing | Diagnostic Test | Laboratory-based HIV and syphilis testing |
|
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013588 | Syphilis Serodiagnosis |
| ID | Term |
|---|---|
| D012698 | Serologic Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
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