Ending the Epidemic Interventions in the Dental Setting - UH3

Not Applicable

Not yet recruiting

• Conditions: HIV-1-infection

• Registration Number: NCT06890988
• Lead Sponsor: Columbia University

Brief Summary

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

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-24
• Last Update Posted: 2025-03-24
• Study Start: 2025-03-31
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Proportion of patients that complete point of care HIV testing out of patient encounters receiving clinical decision support (CDS) prompts for HIV testing	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 Outcome Measures

Name	Time	Method
Provider acceptability of multicomponent HIV service package in dental clinics	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.
Provider feasibility of multicomponent HIV service package in dental clinics	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.
Proportion of patients receiving CDS prompt for HIV testing that complete subsequent HIV testing outside of the dental clinic	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.
Proportion of patients receiving CDS prompt for HIV testing with subsequent appointment at an HIV prevention clinic	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.
Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication	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.

Trial Locations

Locations (3)

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

Weill Cornell Medical Center / NewYork-Presbyterian Hospital; 🇺🇸 New York, New York, United States

NYP-Queens; 🇺🇸 Queens, New York, United States