ETE Interventions in the Dental Setting

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05584501
Collaborator
National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
153
2
2
8.1
76.5
9.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Care Navigator
  • Other: Health Information Supported Ending the HIV Epidemic (ETE) Activities in Dental Setting
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
153 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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)
Primary Purpose:
Health Services Research
Official Title:
Effectiveness of Comprehensive Ending the Epidemic (ETE) Interventions in the Dental Setting
Actual Study Start Date :
Sep 26, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Dental Team

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

Other: Health Information Supported Ending the HIV Epidemic (ETE) Activities in Dental Setting
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.

Active Comparator: Care Navigator

ETE activity implementation with additional Care Navigator resource

Other: Care Navigator
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.

Other: Health Information Supported Ending the HIV Epidemic (ETE) Activities in Dental Setting
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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability among Patients [Within 2 weeks after the patient's dental visit]

    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.

  2. Acceptability among Providers [Within 2 weeks after the patient's dental visit]

    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.

  3. Feasibility among Providers [Within 9 months from baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Irving Medical Center / NewYork-Presbyterian Hospital New York New York United States 10032
2 Weill Cornell Medical Center / NewYork-Presbyterian Hospital New York New York United States 10065

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Michael Yin, MD, MS, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Columbia University
ClinicalTrials.gov Identifier:
NCT05584501
Other Study ID Numbers:
  • AAAT8854
  • 1UG3DE031258
First Posted:
Oct 18, 2022
Last Update Posted:
Oct 18, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Columbia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2022