HIV Service Package for HIV

(ETE Trial)

Recruiting at 2 trial locations

Overseen By Michael Yin, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Inability to provide consent

Compensation: Varies

Number of Visits: Unknown

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how information technology can enhance HIV prevention and care in dental offices. It compares two approaches: one where the dental team independently uses a multicomponent HIV service package, and another where a Care Navigator assists the team. The goal is to determine if a Care Navigator improves the efficiency of HIV care delivery. Dental team members with direct patient contact who can provide written consent are eligible to participate. As an unphased trial, this study offers a unique opportunity to contribute to innovative HIV care solutions in dental settings.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this IT-supported HIV service package is safe for use in dental care settings?

Research has shown that using a Care Navigator as part of an HIV Service Package is generally safe. In a study with 700 people living with HIV, patient navigation helped many participants find more stable housing, suggesting the program is well-received and beneficial.

The Care Navigator serves as an additional resource to guide patients through HIV prevention and care in dental settings. The aim is to improve health without causing harm. No major side effects have been reported with this approach, offering reassurance to potential participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HIV Service Package because it introduces a Care Navigator into the HIV treatment process. Unlike the traditional approach that often involves standard medical care, this package focuses on providing comprehensive support with a personal touch. The Care Navigator works closely with individuals to guide them through various health services, potentially improving adherence to treatment and overall health outcomes. This personalized assistance could bridge gaps in care and offer more holistic support, which is an exciting development in managing HIV.

What evidence suggests that this trial's treatments could be effective for HIV?

Research has shown that including a Care Navigator in an HIV support program can improve health outcomes for people with HIV. In this trial, one group will receive the Multicomponent HIV Service Package with a Care Navigator, while another group will receive the package without one. One study found that 59.6% of participants improved their housing situation after working with a patient navigator. Patient navigators help individuals stay connected to healthcare by facilitating communication with doctors and finding resources. Overall, evidence suggests that patient navigation is a promising method to enhance care for people with HIV. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for dental team members (providers, hygienists, dental assistants, care navigators) at selected sites who have direct contact with patients and can give written consent. It's not open to those unable to consent.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive clinical decision support prompts for HIV testing in dental settings, with or without a Care Navigator

10 months

Regular dental visits with CDS prompts

Follow-up

Participants are monitored for completion of HIV testing and subsequent healthcare actions

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Care Navigator
• Multicomponent HIV Service Package

Trial Overview The study tests a multicomponent HIV service package delivered through information technology in the dental setting, along with the support of a Care Navigator.

How Is the Trial Designed?

Group I: Enhanced Dental Care Team model with a Care Navigator Experimental Treatment 2 Interventions

Multicomponent HIV Service Package delivered with a Care Navigator

Group II: Standard Dental Care Team model Placebo Group 1 Intervention

Multicomponent HIV Service Package delivered without a Care Navigator

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Published Research Related to This Trial

In a study involving 700 people living with HIV over four years, 59.6% of participants transitioned to more stable housing after receiving patient navigation support.

Those who achieved stable housing had significantly better HIV outcomes, including higher rates of retention in care, increased likelihood of being prescribed antiretroviral therapy, and improved viral suppression rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Housing Status on the HIV Continuum of Care: Results From a Multisite Study of Patient Navigation Models to Build a Medical Home for People Living With HIV Experiencing Homelessness. Rajabiun, S., Tryon, J., Feaster, M., et al.[2020]

Case management interventions were most consistently linked to improvements in immunological outcomes for people living with HIV/AIDS, although they did not show clear benefits for other health measures.

Outreach interventions demonstrated significant improvements in mortality rates, access to antiretroviral medications, and overall healthcare utilization, suggesting they are effective strategies for enhancing care for HIV/AIDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organization of care for persons with HIV-infection: a systematic review. Handford, CD., Tynan, AM., Agha, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06890988?intr=%22Dental%20Care%22&aggFilters=status:not%20rec&rank=10

Study Details | NCT06890988 | Ending the Epidemic ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12009800/

results from the IMPROVE clustered randomized study The “Integrated Management Team to Improve Maternal-Child Outcomes” (IMPROVE) study measured the effect of a package of facility-based interventions on PVT and ...

3. withpower.com withpower.com/trial/phase-human-immunodeficiency-virus-type-1-hiv-1-infection-2-2025-dd58f

HIV Service Package for HIV (ETE Trial) In a study involving 700 people living with HIV over four years, 59.6% of participants transitioned to more stable housing after receiving patient navigation ...

4. amidacareny.org amidacareny.org/wp-content/uploads/Patient-Navigation-Final.pdf

An HIV health plan patient navigation program Navigators assist HIV patients to make better use of available resources, develop effective communication with providers, sustain. HIV care over ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6724743/

Is HIV patient navigation associated with HIV care ... Conclusions: Available evidence suggests that patient navigation is a potentially effective strategy to enhance engagement in care among persons with HIV (PWH).

6. hptn.org hptn.org/sites/default/files/inline-files/HPTN_091_Protocol_Final_Version_1.0_13Apr2020.pdf

HPTN 091 Integrating HIV Prevention, Gender-Affirmative ... Intervention to be Provided: Multi-component HIV Prevention Care Package. Intervention Component. Description. Theoretical. Foundation.