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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
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The proposed research hypothesizes that point-of-care testing (POCT) for sexually transmitted infections (STIs) gonorrhea and chlamydia will be a feasible, acceptable, and appropriate implementation strategy for improving HIV testing and Pre-exposure prophylaxis (PrEP) delivery in youth, by increasing opportunities for clinician-patient counseling, decreasing loss to follow up, and allowing for same-day HIV prevention service provision. This hypothesis will be tested in a pragmatic non-randomized trial comparing clinical (HIV testing and PrEP counseling and prescription) and implementation (feasibility, acceptability, and appropriateness) outcomes between adolescents receiving POCT compared to laboratory-based testing at three clinics within a large pediatric health system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Point-of-Care Tested | Experimental | Participants in the intervention arm have received point-of-care testing for sexually transmitted infections. |
|
| Lab Tested | No Intervention | Participants in the control arm have received lab-based testing for sexually transmitted infections. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gonorrhea/chlamydia Point-of-Care Testing | Behavioral | Point-of-care testing for sexually transmitted infections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of HIV Test Completion | Rates of HIV test completion on the day of gonorrhea/chlamydia testing will be compared between those who receive point-of-care vs. lab-based STI testing. | Day 1 - Measured on date of STI testing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who received PrEP counseling | PrEP counseling will be measured using visit note data from the date of the STI testing encounter | Day 1 - Same day as STI testing encounter |
| Time to STI treatment |
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Inclusion Criteria:
- Patients age 16-24 years receiving POCT or lab-based GC/CT testing
Exclusion Criteria:
- Patients with known HIV or active PrEP prescriptions.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naomi Pressman, MS, RD | Contact | (212) 731-7810 | naomi.pressman@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Wood, MD, MSHP | Mount Sinai Adolescent Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
All of the individual participant data collected during the trial, after deidentification.
Specify Other Time Frame After the end of the award period. No end date.
Researchers who provide a methodologically sound proposal. Any purpose. Data will be findable for the research community through the NIHM Data Archive Collection.
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| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| D002690 | Chlamydia Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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Days between STI test order and delivery of antibiotics for STI treatment, measured using EHR data
| Time from STI diagnosis to treatment, up to 9 months |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D002694 | Chlamydiaceae Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |