Health TrialsbyHealthPanel

Ending the Epidemic Interventions in the Dental Setting - UH3

ConditionHIV-1-infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Care Navigator

    Other intervention

    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

    Other intervention

    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.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Standard Dental Care Team modelPlacebo comparator 1 intervention
Group B: Enhanced Dental Care Team model with a Care NavigatorExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
10 months after start of each arm

Secondary outcomes

1

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.

Time frame
5-10 months after start of each arm
2

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.

Time frame
5-10 months after start of each arm
3

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.

Time frame
Within 12 months following dental visit
4

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.

Time frame
Within 12 months following dental visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Source ClinicalTrials.gov
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