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| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3DE031258 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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The purpose of this study is to use information technology (IT) to support the efficient delivery of HIV prevention and care best practices in the dental care setting.
Routine preventative HIV screening in all health care settings is considered a best practice by the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) Ending the Epidemic (ETE) Initiative, the New York State Blueprint to End the AIDS Epidemic. Despite this, many patients are not screened for HIV during routine care, including in dental care settings, resulting in missed opportunities for identifying undiagnosed HIV infections and providing education for pre-exposure prophylaxis (PrEP). This study will use information technology to support the delivery of HIV prevention and care best practices in the dental care setting. Dental residents will receive a Best Practice (BPA) alert whenever they have a patient who should be offered HIV screening. This BPA is linked to an order set to simplify ordering HIV tests and reporting results.
A critical knowledge gap for implementing these ETE activities in the dental setting is whether comprehensive ETE efforts could be integrated into existing dental teams consisting of practitioners, dental assistants and hygienists or require augmentation by a dedicated care navigator. To evaluate these two models, the investigators will conduct a crossover clinical trial in 3 urban general dentistry programs (NYP-Columbia, NYP-Cornell, NYP-Queens) randomized to one of 2 arms: (AB) Standard Dental Care Team model followed by crossover to an Enhanced Dental Care Team model with a Care Navigator, or (BA) Enhanced Dental Care Team model with a Care Navigator followed by crossover to a Standard Dental Care Team model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dental Care Team model | Placebo Comparator | Multicomponent HIV Service Package delivered without a Care Navigator |
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| Enhanced Dental Care Team model with a Care Navigator | Experimental | Multicomponent HIV Service Package delivered with a Care Navigator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care Navigator | Other | The Care Navigator will be added to the dental team as an added resource to:
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients that complete point of care HIV testing out of patient encounters receiving clinical decision support (CDS) prompts for HIV testing | Proportion of patients receiving clinical decision support (CDS) prompts for HIV testing that complete point of care HIV testing over the intervention period under the Enhanced versus Standard Dental Care Models. | 10 months after start of each arm |
| Measure | Description | Time Frame |
|---|---|---|
| Provider acceptability of multicomponent HIV service package in dental clinics | Provider acceptability of multicomponent HIV service package in dental clinics under the Enhanced versus Standard Dental Care Models. Acceptability will be assessed using the validated Acceptability of Intervention Measure (AIM). AIM is a 4-item scale where respondents rate each item using a 5-point ordinal scale that ranges from "completely disagree=1" to "completely agree=5". The AIM is scored by averaging responses across the 4 items. A higher average score indicates greater acceptability, which is a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
- Inability to provide written informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Yin, MD, MS | Contact | 212-305-7185 | mty4@cumc.columbia.edu | |
| Nadia Nguyen, PhD | Contact | nn2442@cumc.columbia.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center / NewYork-Presbyterian Hospital | Recruiting | New York | New York | 10032 | United States |
De-identified participant data may be shared with other researchers within Columbia University at the discretion of the Principal Investigator, and only when the Institutional Review Board (IRB) approval has been granted to allow for the sharing of such data.
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Sites will be randomized to one of 2 arms: (AB) Standard Dental Care Team model followed by crossover to an Enhanced Dental Care Team model with a Care Navigator, or (BA) Enhanced Dental Care Team model with a Care Navigator followed by crossover to a Standard Dental Care Team model.
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| Multicomponent HIV Service Package | Other | Multicomponent HIV Service Package consisting of:
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| 5-10 months after start of each arm |
| Provider feasibility of multicomponent HIV service package in dental clinics | Provider feasibility of multicomponent HIV service package in dental clinics under the Enhanced versus Standard Dental Care Models. Feasibility will be assessed using the validated Feasibility of Intervention Measure (FIM). FIM is a 4-item scale where respondents rate each item using a 5-point ordinal scale that ranges from "completely disagree=1" to "completely agree=5". The FIM is scored by averaging responses across the 4 items. A higher average score indicates greater acceptability, which is a better outcome. | 5-10 months after start of each arm |
| Proportion of patients receiving CDS prompt for HIV testing that complete subsequent HIV testing outside of the dental clinic | Proportion of patients receiving CDS prompt for HIV testing that complete subsequent HIV testing outside of the dental clinic under the Enhanced versus Standard Dental Care Models. | Within 12 months following dental visit |
| Proportion of patients receiving CDS prompt for HIV testing with subsequent appointment at an HIV prevention clinic | Proportion of patients receiving CDS prompt for HIV testing with subsequent appointment at an HIV prevention clinic under the Enhanced versus Standard Dental Care Models. | Within 12 months following dental visit |
| Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication | Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication under the Enhanced versus Standard Dental Care Models. | Within 12 months following dental visit |
| Weill Cornell Medical Center / NewYork-Presbyterian Hospital | Not yet recruiting | New York | New York | 10065 | United States |
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| NYP-Queens | Not yet recruiting | Queens | New York | 11365 | United States |
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