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NCT Number: NCT06890988

Ending the Epidemic Interventions in the Dental Setting - UH3

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.

Recruiting

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Care Navigator

Other

The Care Navigator will be added to the dental team as an added resource to:

  • 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.
  • Provide technical assistance
  • Provide logistical assistance ; and
  • Support dental team in educating patients about HIV prevention and treatment options

Multicomponent HIV Service Package

Other

Multicomponent HIV Service Package consisting of:

  • 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.
  • Point-of-care HIV testing in the dental clinic.
  • 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.

Primary outcomes

  1. Proportion of patients that complete point of care HIV testing out of patient encounters receiving clinical decision support (CDS) prompts for HIV testing

    Time frame: 10 months after start of each arm

    Proportion of patients receiving clinical decision support (CDS) prompts for HIV testing that complete point of care HIV testing over the intervention period under the Enhanced versus Standard Dental Care Models.

Secondary outcomes

  1. Provider acceptability of multicomponent HIV service package in dental clinics

    Time frame: 5-10 months after start of each arm

    Provider acceptability of multicomponent HIV service package in dental clinics under the Enhanced versus Standard Dental Care Models. Acceptability will be assessed using the validated Acceptability of Intervention Measure (AIM). AIM is a 4-item scale where respondents rate each item using a 5-point ordinal scale that ranges from "completely disagree=1" to "completely agree=5". The AIM is scored by averaging responses across the 4 items. A higher average score indicates greater acceptability, which is a better outcome.

  2. Provider feasibility of multicomponent HIV service package in dental clinics

    Time frame: 5-10 months after start of each arm

    Provider feasibility of multicomponent HIV service package in dental clinics under the Enhanced versus Standard Dental Care Models. Feasibility will be assessed using the validated Feasibility of Intervention Measure (FIM). FIM is a 4-item scale where respondents rate each item using a 5-point ordinal scale that ranges from "completely disagree=1" to "completely agree=5". The FIM is scored by averaging responses across the 4 items. A higher average score indicates greater acceptability, which is a better outcome.

  3. Proportion of patients receiving CDS prompt for HIV testing that complete subsequent HIV testing outside of the dental clinic

    Time frame: Within 12 months following dental visit

    Proportion of patients receiving CDS prompt for HIV testing that complete subsequent HIV testing outside of the dental clinic under the Enhanced versus Standard Dental Care Models.

  4. Proportion of patients receiving CDS prompt for HIV testing with subsequent appointment at an HIV prevention clinic

    Time frame: Within 12 months following dental visit

    Proportion of patients receiving CDS prompt for HIV testing with subsequent appointment at an HIV prevention clinic under the Enhanced versus Standard Dental Care Models.

  5. Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication

    Time frame: Within 12 months following dental visit

    Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication under the Enhanced versus Standard Dental Care Models.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Yin, MD, MS

CONTACT

[email protected]

212-305-7185

Nadia Nguyen, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Effectiveness of Comprehensive Ending the Epidemic (ETE) Interventions in the Dental Setting

Acronym: ETE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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