ETE Interventions in the Dental Setting

NCT ID: NCT05584501

Last Updated: 2024-05-13

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

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2024-10-31

Brief Summary

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The purpose of this study is to use information technology (IT) to support the delivery of HIV prevention and care best practices in the dental care setting to meet the Department of Health and Human Services (DHHS) Ending the HIV Epidemic (ETE) goals.

Detailed Description

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Routine HIV screening in all health care settings is considered a best practice by the Centers for Disease Control and Prevention (CDC), DHHS Ending the Epidemic Initiative, the New York State Blueprint to End the AIDS Epidemic, and is mandated by law in New York for all individuals over the age of 13 who receive hospital or primary care. 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, providing education for and linkage to PrEP, and linking and re-engaging HIV-positive patients into HIV care. The investigators will use information technology in the following two ways to support the delivery of HIV prevention and care best practices in the dental care setting to meet the DHHS Ending the HIV Epidemic (ETE) goals. First, Dental Teams will receive a Best Practice (BPA) alert whenever they have a patient who should be offered HIV testing. This BPA is linked to an order set to simplify ordering HIV tests and reporting results. Second, Dental teams will be contacted whenever they have a patient who is known to have HIV and is out of HIV care. 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. Therefore the investigators will pilot the Dental Team and Care Navigator models at two different dental sites (NYP-Columbia and NYP-Weill Cornell) using a cross-over design to evaluate acceptability and feasibility of providing HIV prevention and treatment services supported by these health IT strategies in the dental setting under these two care delivery models. If the strategies are found to be acceptable and feasible for both dental care patients and providers, then the study will expand to 4 sites and examine the effectiveness of these strategies for delivering HIV prevention and care best practices in the dental setting.

Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Each site will experience a care delivery model for 3 months, followed by a 1 month washout period, and then 3 months with the alternative care delivery model.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Dental Team

ETE activity implementation with existing Dental Team only (i.e. practitioners, dental assistants, hygienists)

Group Type PLACEBO_COMPARATOR

Health Information Supported Ending the HIV Epidemic (ETE) Activities in Dental Setting

Intervention Type OTHER

Dental Teams will receive a Best Practice Alert (BPA) when they have a patient who should be offered HIV testing. Dental Teams will also be notified when they have a patient known to be HIV positive but out of HIV care.

Care Navigator

ETE activity implementation with additional Care Navigator resource

Group Type ACTIVE_COMPARATOR

Care Navigator

Intervention Type OTHER

The Dental Team will have a Care Navigator as an added resource to assist with offering, implementing, and counseling for HIV testing; providing PrEP education and linkage; and providing linkage and re-linkage to HIV care.

Health Information Supported Ending the HIV Epidemic (ETE) Activities in Dental Setting

Intervention Type OTHER

Dental Teams will receive a Best Practice Alert (BPA) when they have a patient who should be offered HIV testing. Dental Teams will also be notified when they have a patient known to be HIV positive but out of HIV care.

Interventions

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Care Navigator

The Dental Team will have a Care Navigator as an added resource to assist with offering, implementing, and counseling for HIV testing; providing PrEP education and linkage; and providing linkage and re-linkage to HIV care.

Intervention Type OTHER

Health Information Supported Ending the HIV Epidemic (ETE) Activities in Dental Setting

Dental Teams will receive a Best Practice Alert (BPA) when they have a patient who should be offered HIV testing. Dental Teams will also be notified when they have a patient known to be HIV positive but out of HIV care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Dental Team/Patient Navigator:

To be eligible, members of the Dental Team or Patient Navigator need to have direct contact with patients at a participating dental clinic site during the months of the pilot study.

Patient:

To be eligible, patients must:

* Be 18 years or older
* Have at least one visit during the months of the pilot study at a participating dental clinic
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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Responsibility Role SPONSOR

Principal Investigators

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Michael Yin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

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 RECRUITING

Countries

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United States

Central Contacts

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Michael Yin, MD, MS

Role: CONTACT

212-305-7185

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

Other Identifiers

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1UG3DE031258

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT8854

Identifier Type: -

Identifier Source: org_study_id

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