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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the HIV Service Package treatment?

Research shows that using patient navigators and support services, like those in the HIV Service Package, can improve housing stability and lead to better HIV-related outcomes, such as higher rates of medication adherence and viral suppression. Additionally, case management and outreach interventions have been linked to improved medical and economic outcomes for people living with HIV. ^{1 2 3 4 5}

How is the HIV Service Package treatment different from other HIV treatments?

The HIV Service Package treatment is unique because it includes a Care Navigator who helps link patients to HIV care and supportive services, improving engagement and retention in care. This approach is different from standard treatments as it focuses on personalized care management and support, rather than just medication. ^{4 5 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Organization of care for persons with HIV-infection: a systematic review. [2019]

2. United States 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. [2020]

3. England pubmed.ncbi.nlm.nih.gov

PROMISE (Program Refinements to Optimize Model Impact and Scalability based on Evidence): a cluster-randomised, stepped-wedge trial assessing effectiveness of the revised versus original Ryan White Part A HIV Care Coordination Programme for patients with barriers to treatment in the USA. [2021]

4. England pubmed.ncbi.nlm.nih.gov

HIV multidisciplinary teams work: support services improve access to and retention in HIV primary care. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

HIV Nurse Navigation: Charting the Course to Improve Engagement in Care and HIV Virologic Suppression. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Results and Implications of Routine HIV Testing in the Inpatient Setting: A Descriptive Analysis. [2018]

7. England pubmed.ncbi.nlm.nih.gov

A type II implementation-effectiveness hybrid quasi-experimental pilot study of a clinical intervention to re-engage people living with HIV into care, 'Lost & Found': an implementation science protocol. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Health Communication Interventions Within a Combination Intervention Strategy for Improving Linkage and Retention in HIV Care in Mozambique. [2020]