An interventional study of Care Navigator and Health Information Supported Ending the HIV Epidemic (ETE) Activities in Dental Setting in HIV Infections, sponsored by Columbia University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Columbia University · Not applicable, Interventional, and Health services research
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.
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.
4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 153 is above the median of 83 across 3,250 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
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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:
Exclusion Criteria:
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
ETE activity implementation with additional Care Navigator resource
Other: Care Navigator · Other: Health Information Supported Ending the HIV Epidemic (ETE) Activities in Dental Setting
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Within 9 months from baseline
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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