HIV-1-infectionETENCT06890988
Ending the Epidemic Interventions in the Dental Setting - UH3
A study testing Care Navigator and Multicomponent HIV Service Package in people with HIV-1-infection, run by Columbia University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Care Navigator and Multicomponent HIV Service Package
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Mar 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to provide written informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nadia Nguyen, PhD contact
United States3 sites, 3 recruiting
- Recruiting
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032
Michael Yin, MD, MS, 212-305-7185, mty4@cumc.columbia.edu
Nadia Nguyen, PhD, 212-304-6212, nn2442@cumc.columbia.edu
- Not yet recruiting
Weill Cornell Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10065
Ariel Blanchard, DMD, (212) 746-5175, aab9028@med.cornell.edu
Nadia Nguyen, PhD, 212-304-6212, nn2442@cumc.columbia.edu
- Not yet recruiting
NYP-Queens
Queens, New York, 11365
Marsha Rubin, DDS, Mer2009@med.cornell.edu
About this study
Official title: Effectiveness of Comprehensive Ending the Epidemic (ETE) Interventions in the Dental Setting
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.
Read the 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.
- Conditions
- HIV-1-infection
- Being tested
- Care Navigator, Multicomponent HIV Service Package
- Keywords
- clinical decision support, acceptability, feasibility, implementation science, HIV testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care NavigatorOther
The Care Navigator will be added to the dental team as an added resource to:
- 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.
- Provide technical assistance
- Provide logistical assistance ; and
- Support dental team in educating patients about HIV prevention and treatment options
Multicomponent HIV Service PackageOther
Multicomponent HIV Service Package consisting of:
- 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.
- Point-of-care HIV testing in the dental clinic.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Dental Care Team model | Placebo comparator | Multicomponent HIV Service Package delivered without a Care Navigator Receives: Other: Multicomponent HIV Service Package |
| Enhanced Dental Care Team model with a Care Navigator | Experimental | Multicomponent HIV Service Package delivered with a Care Navigator Receives: Other: Care Navigator; Other: Multicomponent HIV Service Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that complete point of care HIV testing out of patient encounters receiving clinical decision support (CDS) prompts for HIV testing
Proportion 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.
Measured: 10 months after start of each arm
Secondary outcomes (5)
Provider acceptability of multicomponent HIV service package in dental clinics
Provider 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.
Measured: 5-10 months after start of each arm
Provider feasibility of multicomponent HIV service package in dental clinics
Provider 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.
Measured: 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
Proportion 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.
Measured: Within 12 months following dental visit
Proportion of patients receiving CDS prompt for HIV testing with subsequent appointment at an HIV prevention clinic
Proportion of patients receiving CDS prompt for HIV testing with subsequent appointment at an HIV prevention clinic under the Enhanced versus Standard Dental Care Models.
Measured: Within 12 months following dental visit
Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication
Proportion of patients receiving CDS prompt for HIV testing subsequently prescribed pre-exposure prophylaxis (PrEP) medication under the Enhanced versus Standard Dental Care Models.
Measured: Within 12 months following dental visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start31 Mar 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Michael Yin, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890988
- Sponsor's protocol ID
- AAAT8854 - UH3
- Other IDs
- 4UH3DE031258
- Acronym
- ETE
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Comprehensive Ending the Epidemic (ETE) Interventions in the Dental Setting
- ClinicalTrials.gov ID
- NCT06890988
- Acronym / sponsor ID
- ETE / AAAT8854 - UH3
- Conditions
- HIV-1-infection
- Keywords
- clinical decision support, acceptability, feasibility, implementation science, HIV testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Dental Care Team model | Placebo comparator | Other: Multicomponent HIV Service PackageMulticomponent HIV Service Package delivered without a Care Navigator |
| Enhanced Dental Care Team model with a Care Navigator | Experimental | Other: Care Navigator, Other: Multicomponent HIV Service PackageMulticomponent HIV Service Package delivered with a Care Navigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care NavigatorThe 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 | Enhanced Dental Care Team model with a Care Navigator |
| Multicomponent HIV Service PackageMulticomponent 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. | Other | Enhanced Dental Care Team model with a Care Navigator, Standard Dental Care Team model |
Primary outcome
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
Proportion 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadia Nguyen, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Navigator and Multicomponent HIV Service Package in people with HIV-1-infection, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Yin, MD, MS (212-305-7185, mty4@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.