Clinical trial NCT06890988: Ending the Epidemic Interventions in the Dental Setting - UH3
Official title: Effectiveness of Comprehensive Ending the Epidemic (ETE) Interventions in the Dental Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV-1-infection
Keywords: clinical decision support
acceptability
feasibility
implementation science
HIV testing
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2025-03-24
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients that complete point of care HIV testing out of patient encounters receiving clinical decision support (CDS) prompts for HIV testing
timeFrame: 10 months after start of each arm
Secondary outcomes:
measure: Provider acceptability of multicomponent HIV service package in dental clinics
timeFrame: 5-10 months after start of each arm
measure: Provider feasibility of multicomponent HIV service package in dental clinics
timeFrame: 5-10 months after start of each arm
measure: Proportion of patients receiving CDS prompt for HIV testing that complete subsequent HIV testing outside of the dental clinic
timeFrame: Within 12 months following dental visit
measure: Proportion of patients receiving CDS prompt for HIV testing with subsequent appointment at an HIV prevention clinic
timeFrame: Within 12 months following dental visit
measure: Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication
timeFrame: Within 12 months following dental visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center / NewYork-Presbyterian Hospital
state: New York
city: Queens
country: United States
facility: NYP-Queens
state: New York
Study officials:
References: