Ending the Epidemic Interventions in the Dental Setting - UH3 (ETE)

Columbia University

Status: Enrolling

Conditions: HIV-1-infection

Treatments: Other: Multicomponent HIV Service Package; Other: Care Navigator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06890988

4UH3DE031258 (U.S. NIH Grant/Contract)

AAAT8854 - UH3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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128 participants in 2 patient groups, including a placebo group

Standard Dental Care Team model

Placebo Comparator group

Description:

Multicomponent HIV Service Package delivered without a Care Navigator

Treatment:

Other: Multicomponent HIV Service Package

Enhanced Dental Care Team model with a Care Navigator

Experimental group

Description:

Multicomponent HIV Service Package delivered with a Care Navigator

Treatment:

Other: Care Navigator

Other: Multicomponent HIV Service Package