Trials Today

Ending the Epidemic Interventions in the Dental Setting - UH3

Purpose

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.

Condition

HIV-1-infection

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Member of the Dental Team (Provider, Hygienist, Dental Assistant, Care Navigator) at one of the randomized sites with direct patient contact - Able to provide written informed consent.

Exclusion Criteria

Inability to provide written informed consent.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Primary Purpose: Health Services Research
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator Standard Dental Care Team model	Multicomponent HIV Service Package delivered without a Care Navigator	Other: Multicomponent HIV Service Package Multicomponent HIV Service Package consisting of: 1. Clinical Decision Support (CDS) within electronic medical record (EMR) system to help providers identify patients who would benefit from HIV screening or re-engagement in HIV care. 2. Point-of-care HIV testing in the dental clinic. 3. Patient and provider-facing educational materials to support providers in discussing HIV prevention options (for patients who test HIV negative) and treatment (for patients who test HIV positive or are out of HIV care) options.
Experimental Enhanced Dental Care Team model with a Care Navigator	Multicomponent HIV Service Package delivered with a Care Navigator	Other: Care Navigator The Care Navigator will be added to the dental team as an added resource to: 1. Champion the use of the multicomponent HIV intervention in the dental clinic among clinic administrators, residents, dental hygienists, dental assistants, and other dental team staff. 2. Provide technical assistance 3. Provide logistical assistance ; and 4. Support dental team in educating patients about HIV prevention and treatment options Other: Multicomponent HIV Service Package Multicomponent HIV Service Package consisting of: 1. Clinical Decision Support (CDS) within electronic medical record (EMR) system to help providers identify patients who would benefit from HIV screening or re-engagement in HIV care. 2. Point-of-care HIV testing in the dental clinic. 3. Patient and provider-facing educational materials to support providers in discussing HIV prevention options (for patients who test HIV negative) and treatment (for patients who test HIV positive or are out of HIV care) options.

Recruiting Locations

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York 5128581, New York 5128638 10032

Contact:
Michael Yin, MD, MS
212-305-7185
mty4@cumc.columbia.edu

More Details

NCT ID: NCT06890988
Status: Recruiting
Sponsor: Columbia University

Study Contact

Michael Yin, MD, MS
212-305-7185
mty4@cumc.columbia.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.