Skip to content

Ending the Epidemic Interventions in the Dental Setting - UH3

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06890988
Acronym
ETE
Enrollment
128
Registered
2025-03-24
Start date
2025-03-31
Completion date
2027-09-01
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

Keywords

clinical decision support, acceptability, feasibility, implementation science, HIV testing

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.

Interventions

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

OTHERMulticomponent 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.

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients that complete point of care HIV testing out of patient encounters receiving clinical decision support (CDS) prompts for HIV testing10 months after start of each armProportion 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

MeasureTime frameDescription
Provider acceptability of multicomponent HIV service package in dental clinics5-10 months after start of each armProvider 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 clinics5-10 months after start of each armProvider 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 clinicWithin 12 months following dental visitProportion 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 clinicWithin 12 months following dental visitProportion 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) medicationWithin 12 months following dental visitProportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication under the Enhanced versus Standard Dental Care Models.

Countries

United States

Contacts

Primary ContactMichael Yin, MD, MS
mty4@cumc.columbia.edu212-305-7185
Backup ContactNadia Nguyen, PhD
nn2442@cumc.columbia.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026