Recruiting

HIV Prevention

Sponsor:

Columbia University

Code:

NCT06890988

Conditions

HIV-1-infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Care Navigator

Multicomponent HIV Service Package

Study Details

Brief 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.

Conditions

HIV-1-infection

Study ID

NCT06890988

Start date

Mar 31, 2025

Status verified date

Jul, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

placebo comparator: Standard Dental Care Team model

Multicomponent HIV Service Package delivered without a Care Navigator

experimental: Enhanced Dental Care Team model with a Care Navigator

Multicomponent HIV Service Package delivered with a Care Navigator

Interventions

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

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 HIV care) options.

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 ]

Central Contacts and Locations

Central contacts

Michael Yin, MD, MS

212-305-7185mty4@cumc.columbia.edu

Nadia Nguyen, PhD

nn2442@cumc.columbia.edu

Locations

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Michael Yin, MD, MS

212-305-7185mty4@cumc.columbia.edu

Nadia Nguyen, PhD

212-304-6212nn2442@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Jul 23, 2025

Last verified

Jul, 2025

Keywords

  • clinical decision support
  • acceptability
  • feasibility
  • implementation science
  • HIV testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-07-23.