Ending the Epidemic Interventions in the Dental Setting - UH3

NCT ID: NCT06890988

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV-1-infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard Dental Care Team model

Multicomponent HIV Service Package delivered without a Care Navigator

Group Type PLACEBO_COMPARATOR

Multicomponent HIV Service Package

Intervention Type OTHER

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.

Enhanced Dental Care Team model with a Care Navigator

Multicomponent HIV Service Package delivered with a Care Navigator

Group Type EXPERIMENTAL

Care Navigator

Intervention Type OTHER

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

Multicomponent HIV Service Package

Intervention Type OTHER

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.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Michael Yin

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, United States

Site Status RECRUITING

Weill Cornell Medical Center / NewYork-Presbyterian Hospital

New York, New York, United States

Site Status NOT_YET_RECRUITING

NYP-Queens

Queens, New York, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Michael Yin, MD, MS

Role: CONTACT

212-305-7185

Nadia Nguyen, PhD

Role: CONTACT

Facility Contacts

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Michael Yin, MD, MS

Role: primary

212-305-7185

Nadia Nguyen, PhD

Role: backup

212-304-6212

Ariel Blanchard, DMD

Role: primary

212-746-5175

Nadia Nguyen, PhD

Role: backup

212-304-6212

Marsha Rubin, DDS

Role: primary

Other Identifiers

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4UH3DE031258

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT8854 - UH3

Identifier Type: -

Identifier Source: org_study_id

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