Clinical Decision Support System for HIV Prevention

(PrEDICT Trial)

Recruiting at 2 trial locations

Overseen By Amanda Isaacs, MSPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Pilgrim Health Care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

4 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Clinical Decision Support for PrEP?

Research shows that clinical decision support systems (CDSS) can help increase the knowledge of healthcare providers about HIV prevention and improve the likelihood of prescribing pre-exposure prophylaxis (PrEP) to those at risk. These systems can also address barriers like lack of training and time constraints, making it easier for providers to offer PrEP to patients who need it. ^{1 2 3 4 5}

How is the Clinical Decision Support for PrEP treatment different from other HIV prevention treatments?

The Clinical Decision Support for PrEP is unique because it uses a system to help healthcare providers make informed decisions about prescribing PrEP, addressing barriers like lack of training and time constraints. This approach aims to increase the use of PrEP by integrating alerts and guidance into electronic health records, making it easier for providers to offer this preventive treatment. ^{1 3 4 5 6}

What is the purpose of this trial?

Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the federal initiative to end the HIV epidemic. However, healthcare providers lack tools to identify patients who are at increased risk for HIV infection and thus likely to benefit from PrEP. This pilot study will test the hypothesis that an electronic health record (EHR)-based clinical decision support system that incorporates an HIV risk prediction model can help providers identify patients at increased risk for HIV infection and improve PrEP prescribing in safety-net community health centers. The clinical decision support system will be implemented in the EHR at 2-3intervention clinics, while 2 control clinics will receive standard of care. The primary outcome is PrEP prescriptions. Other key metrics of PrEP-related care to be assessed include medication persistence, adherence to monitoring guidelines for PrEP, and rates of HIV/STI testing and diagnoses. The expected outcome is the foundation for a large-scale cluster randomized trial to test whether EHR-based clinical decision support tools for PrEP can improve PrEP prescribing and prevent new HIV infections in a national network of community health centers.

Research Team

Julia Marcus, PhD

Principal Investigator

Harvard Pilgrim Health Care Institute

Douglas Krakower, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for primary care providers at selected clinics who are licensed to prescribe HIV prevention medication known as PrEP. There are no specific exclusion criteria mentioned, so it appears open to all eligible healthcare professionals in the participating locations.

Inclusion Criteria

I am a licensed provider who can prescribe PrEP at a participating clinic.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of EHR-based clinical decision support system in intervention clinics

9 months

Follow-up

Participants are monitored for PrEP prescriptions, medication persistence, adherence to monitoring guidelines, and rates of HIV/STI testing and diagnoses

6 months

Treatment Details

Interventions

• Clinical Decision Support for PrEP

Trial Overview The study is testing an electronic tool designed to help doctors identify patients at higher risk of HIV and decide if they should be offered PrEP. It compares usual practices with using this new decision support system in community health centers.

Participant Groups

Group I: Arm 1 - Standard of care Active Control 1 Intervention

Standard of care

Group II: Arm 2 - Clinical decision support for PrEP Active Control 1 Intervention

EHR-based decision support tools to support PrEP discussions and prescribing for patients who have increased predicted HIV risk

Who Is Running the Clinical Trial?

Harvard Pilgrim Health Care

Lead Sponsor

Trials

61

Recruited

27,990,000+

OCHIN, Inc.

Collaborator

Trials

24

Recruited

9,964,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Findings from Research

HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV, yet many eligible individuals are not receiving it, highlighting a gap in access to this important preventive measure.

Recommendations from PrEP Coordinators in San Francisco emphasize the need for better training, integration of PrEP into routine care, and proactive strategies to improve patient retention and communication, particularly for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. Shrestha, I., Ming, K., Jimenez, V., et al.[2023]

Healthcare providers in Alabama identified several barriers to prescribing PrEP, including insufficient training, time constraints, and concerns about side effects, which contribute to its underuse in a high HIV incidence area.

Implementing clinical decision support (CDS) tools, along with comprehensive training for all clinic staff, could enhance PrEP prescribing practices and address these barriers effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Health Care Professionals' Perspectives to Refine a Clinical Decision Support Implementation Strategy for Increasing the Prescribing of HIV Preexposure Prophylaxis (PrEP) in Alabama. Humphries, DL., Rhodes, EC., Simon, CL., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Usability and Utility of Human Immunodeficiency Virus Pre-exposure Prophylaxis Clinical Decision Support to Increase Knowledge and Pre-exposure Prophylaxis Initiations among Pediatric Providers. [2023]

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

Primary Care Providers' Perspectives on Using Automated HIV Risk Prediction Models to Identify Potential Candidates for Pre-exposure Prophylaxis. [2022]

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

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. [2023]

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

Using Health Care Professionals' Perspectives to Refine a Clinical Decision Support Implementation Strategy for Increasing the Prescribing of HIV Preexposure Prophylaxis (PrEP) in Alabama. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Provider perspectives on clinical decision support to improve HIV prevention in pediatric primary care: a multiple methods study. [2023]

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

To switch or not to switch: Intentions to switch to injectable PrEP among gay and bisexual men with at least twelve months oral PrEP experience. [2023]