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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Other: Multicomponent HIV Service Package; Other: Care Navigator

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Yin, MD, MS; Phone Number: 212-305-7185; Email: mty4@cumc.columbia.edu
• Study Contact Backup: Name: Nadia Nguyen, PhD; Email: nn2442@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
      • Contact: Michael Yin, MD, MS; Phone Number: 212-305-7185; Email: mty4@cumc.columbia.edu
      • Contact: Nadia Nguyen, PhD; Phone Number: 212-304-6212; Email: nn2442@cumc.columbia.edu
    • New York, New York, United States, 10065
      • Not yet recruiting
      • Weill Cornell Medical Center / NewYork-Presbyterian Hospital
      • Contact: Nadia Nguyen, PhD; Phone Number: 212-304-6212; Email: nn2442@cumc.columbia.edu
      • Contact: Ariel Blanchard, DMD; Phone Number: 212-746-5175; Email: aab9028@med.cornell.edu
    • Queens, New York, United States, 11365
      • Not yet recruiting
      • NYP-Queens
      • Contact: Marsha Rubin, DDS; Email: Mer2009@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard Dental Care Team model; Multicomponent HIV Service Package delivered without a Care Navigator	Other: Multicomponent HIV Service Package; 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.
Experimental: Enhanced Dental Care Team model with a Care Navigator; Multicomponent HIV Service Package delivered with a Care Navigator	Other: Multicomponent HIV Service Package; 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.; Other: Care Navigator; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients that complete point of care HIV testing out of patient encounters receiving clinical decision support (CDS) prompts for HIV testing	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.	10 months after start of each arm

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider acceptability of multicomponent HIV service package in dental clinics	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.	5-10 months after start of each arm
Provider feasibility of multicomponent HIV service package in dental clinics	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.	5-10 months after start of each arm
Proportion of patients receiving CDS prompt for HIV testing that complete subsequent HIV testing outside of the dental clinic	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.	Within 12 months following dental visit
Proportion of patients receiving CDS prompt for HIV testing with subsequent appointment at an HIV prevention clinic	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.	Within 12 months following dental visit
Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication	Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication under the Enhanced versus Standard Dental Care Models.	Within 12 months following dental visit

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: feasibility; implementation science; HIV testing; clinical decision support; acceptability
• Other Study ID Numbers: AAAT8854 - UH3; 4UH3DE031258 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data may be shared with other researchers within Columbia University at the discretion of the Principal Investigator, and only when the Institutional Review Board (IRB) approval has been granted to allow for the sharing of such data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No