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ETE Interventions in the Dental Setting

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Navigator
Health Information Supported Ending the HIV Epidemic (ETE) Activities in Dental Setting
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections focused on measuring Health Information Technology, Care Navigation, Acceptability, Feasibility, Dental Setting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Dental Team/Patient Navigator:

To be eligible, members of the Dental Team or Patient Navigator need to have direct contact with patients at a participating dental clinic site during the months of the pilot study.

Patient:

To be eligible, patients must:

  • Be 18 years or older
  • Have at least one visit during the months of the pilot study at a participating dental clinic

Exclusion Criteria:

  • Not meeting inclusion criteria

Sites / Locations

  • Columbia University Irving Medical Center / NewYork-Presbyterian HospitalRecruiting
  • Weill Cornell Medical Center / NewYork-Presbyterian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Dental Team

Care Navigator

Arm Description

ETE activity implementation with existing Dental Team only (i.e. practitioners, dental assistants, hygienists)

ETE activity implementation with additional Care Navigator resource

Outcomes

Primary Outcome Measures

Acceptability among Patients
Acceptability of the intervention under the two arms 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.
Acceptability among Providers
Acceptability of the intervention under the two arms 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.
Feasibility among Providers
Feasibility of the intervention under the two arms 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 feasibility, which is a better outcome.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2022
Last Updated
October 14, 2022
Sponsor
Columbia University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT05584501
Brief Title
ETE Interventions in the Dental Setting
Official Title
Effectiveness of Comprehensive Ending the Epidemic (ETE) Interventions in the Dental Setting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to use information technology (IT) to support the delivery of HIV prevention and care best practices in the dental care setting to meet the Department of Health and Human Services (DHHS) Ending the HIV Epidemic (ETE) goals.
Detailed Description
Routine HIV screening in all health care settings is considered a best practice by the Centers for Disease Control and Prevention (CDC), DHHS Ending the Epidemic Initiative, the New York State Blueprint to End the AIDS Epidemic, and is mandated by law in New York for all individuals over the age of 13 who receive hospital or primary care. 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, providing education for and linkage to PrEP, and linking and re-engaging HIV-positive patients into HIV care. The investigators will use information technology in the following two ways to support the delivery of HIV prevention and care best practices in the dental care setting to meet the DHHS Ending the HIV Epidemic (ETE) goals. First, Dental Teams will receive a Best Practice (BPA) alert whenever they have a patient who should be offered HIV testing. This BPA is linked to an order set to simplify ordering HIV tests and reporting results. Second, Dental teams will be contacted whenever they have a patient who is known to have HIV and is out of HIV care. 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. Therefore the investigators will pilot the Dental Team and Care Navigator models at two different dental sites (NYP-Columbia and NYP-Weill Cornell) using a cross-over design to evaluate acceptability and feasibility of providing HIV prevention and treatment services supported by these health IT strategies in the dental setting under these two care delivery models. If the strategies are found to be acceptable and feasible for both dental care patients and providers, then the study will expand to 4 sites and examine the effectiveness of these strategies for delivering HIV prevention and care best practices in the dental setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Health Information Technology, Care Navigation, Acceptability, Feasibility, Dental Setting

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each site will experience a care delivery model for 3 months, followed by a 1 month washout period, and then 3 months with the alternative care delivery model.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
153 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dental Team
Arm Type
Placebo Comparator
Arm Description
ETE activity implementation with existing Dental Team only (i.e. practitioners, dental assistants, hygienists)
Arm Title
Care Navigator
Arm Type
Active Comparator
Arm Description
ETE activity implementation with additional Care Navigator resource
Intervention Type
Other
Intervention Name(s)
Care Navigator
Intervention Description
The Dental Team will have a Care Navigator as an added resource to assist with offering, implementing, and counseling for HIV testing; providing PrEP education and linkage; and providing linkage and re-linkage to HIV care.
Intervention Type
Other
Intervention Name(s)
Health Information Supported Ending the HIV Epidemic (ETE) Activities in Dental Setting
Intervention Description
Dental Teams will receive a Best Practice Alert (BPA) when they have a patient who should be offered HIV testing. Dental Teams will also be notified when they have a patient known to be HIV positive but out of HIV care.
Primary Outcome Measure Information:
Title
Acceptability among Patients
Description
Acceptability of the intervention under the two arms 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.
Time Frame
Within 2 weeks after the patient's dental visit
Title
Acceptability among Providers
Description
Acceptability of the intervention under the two arms 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.
Time Frame
Within 2 weeks after the patient's dental visit
Title
Feasibility among Providers
Description
Feasibility of the intervention under the two arms 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 feasibility, which is a better outcome.
Time Frame
Within 9 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Dental Team/Patient Navigator: To be eligible, members of the Dental Team or Patient Navigator need to have direct contact with patients at a participating dental clinic site during the months of the pilot study. Patient: To be eligible, patients must: Be 18 years or older Have at least one visit during the months of the pilot study at a participating dental clinic Exclusion Criteria: Not meeting inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Yin, MD, MS
Phone
212-305-7185
Email
mty4@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Yin, MD, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Yin, MD, MS
Phone
212-305-7185
Email
mty4@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Nadia Nguyen, PhD
Phone
212-304-6212
Email
nn2442@cumc.columbia.edu
Facility Name
Weill Cornell Medical Center / NewYork-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel Blanchard, DMD
Phone
212-746-5175
Email
aab9028@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Nadia Nguyen, PhD
Phone
212-304-6212
Email
nn2442@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data and supporting information will be made available no later than the acceptance for publication of the main findings from the final dataset.
IPD Sharing Access Criteria
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.

Learn more about this trial

ETE Interventions in the Dental Setting

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