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Recruiting NCT06890988

Ending the Epidemic Interventions in the Dental Setting - UH3

No phase Interventional HIV-1-infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Care Navigator, Multicomponent HIV Service Package.
Who it may be relevant to
Registry conditions: HIV-1-infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Care Navigator
    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
  • Other Multicomponent 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 HI

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Provider acceptability 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 [Time frame: 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 [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 [Time frame: Within 12 months following dental visit]
  • Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication [Time frame: Within 12 months following dental visit]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 3 centers
  • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital — New York
  • Weill Cornell Medical Center / NewYork-Presbyterian Hospital — New York
  • NYP-Queens — Queens

Identifiers

NCT: NCT06890988 · AAAT8854 - UH3 · 4UH3DE031258

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗