ETE Interventions in the Dental Setting
Effectiveness of Comprehensive Ending the Epidemic (ETE) Interventions in the Dental Setting
2 other identifiers
interventional
153
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Sep 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2022
CompletedFirst Submitted
Initial submission to the registry
October 14, 2022
CompletedFirst Posted
Study publicly available on registry
October 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedMay 13, 2024
May 1, 2024
2 years
October 14, 2022
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Within 2 weeks after the patient's dental visit
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.
Within 2 weeks after the patient's dental visit
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.
Within 9 months from baseline
Study Arms (2)
Dental Team
PLACEBO COMPARATORETE activity implementation with existing Dental Team only (i.e. practitioners, dental assistants, hygienists)
Care Navigator
ACTIVE COMPARATORETE activity implementation with additional Care Navigator resource
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032, United States
Weill Cornell Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Yin, MD, MS
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2022
First Posted
October 18, 2022
Study Start
September 26, 2022
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
May 13, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- 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.
- 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.
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.