Clinical Decision Support System for HIV Prevention

(PrEDICT Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool designed to help doctors identify patients who might benefit from the HIV prevention medication PrEP. Known as Clinical Decision Support for PrEP, the tool operates within electronic health records to flag patients at higher risk of HIV, aiming to increase PrEP prescriptions. Two groups of clinics are involved: one will use this new tool, while the other will continue with standard care for comparison. The trial seeks primary care providers licensed to prescribe PrEP to participate. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions that could enhance patient outcomes.

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 prior data suggests that this clinical decision support system is safe for use in HIV prevention?

Research has shown that clinical decision support systems, such as the one being tested for HIV prevention, are generally safe. These systems are computer tools that assist doctors by providing crucial information at the right time.

Studies have found that these tools can enhance how doctors prescribe treatments like PrEP (pre-exposure prophylaxis), which helps prevent HIV. Reports have not indicated any harm or negative effects from using these systems. Instead, they are viewed as beneficial in ensuring patients receive appropriate care.

Overall, the goal is to improve healthcare without causing harm. The tool being tested in the trial is expected to be safe and well-tolerated in clinics. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial for HIV prevention because it explores the use of a Clinical Decision Support System (CDSS) specifically for pre-exposure prophylaxis (PrEP). Unlike traditional methods that rely on healthcare providers independently identifying candidates for PrEP, this system integrates with electronic health records to proactively pinpoint individuals at higher risk of HIV. This innovative approach aims to facilitate more timely and personalized PrEP discussions and prescriptions, potentially increasing access and adherence to preventive measures. By streamlining the decision-making process, the CDSS offers a promising avenue for enhancing HIV prevention strategies.

What evidence suggests that this clinical decision support system is effective for improving PrEP prescribing?

Studies have shown that clinical decision support (CDS) systems can increase the number of people tested for HIV and starting pre-exposure prophylaxis (PrEP). These systems use electronic health records (EHR) to identify patients who might benefit from PrEP, simplifying the prescription process for doctors. In this trial, one group will receive standard care, while another will use a clinical decision support tool for PrEP. Research indicates that decision support tools can enhance doctors' decision-making and discussions about PrEP, particularly with individuals at higher risk of HIV. Initial findings suggest a small increase in starting PrEP care when these tools are used. This approach shows promise in boosting HIV prevention efforts by helping healthcare providers more easily identify and support at-risk patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Julia Marcus, PhD

Principal Investigator

Harvard Pilgrim Health Care Institute

Douglas Krakower, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

academic.oup.com

academic.oup.com/ofid/article/12/9/ofaf539/8246006

HIV Oral Pre-exposure Prophylaxis Effectiveness, Adherence ...

A temporary discontinuation occurred in 106/1489 users (7.1%), who returned to the PrEP program after 12 months of interruption, while the other ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05245201?locStr=United+States&country=United+States&aggFilters=status%3A

Clinical Decision Support for PrEP (PrEDICT)

This pilot study will test the hypothesis that an electronic health record (EHR)-based clinical decision support system that incorporates an HIV risk prediction ...

3.

formative.jmir.org

formative.jmir.org/2024/1/e57348

Decision Support Tool to Improve Decision-Making for HIV Pre ...

Our study aimed to develop a DST to improve PrEP decision-making for Black clients and to evaluate the tool's acceptability and usability.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9945664/

Provider perspectives on clinical decision support to ...

Clinical decision support (CDS) is a promising intervention for improving uptake of HIV testing and pre-exposure prophylaxis (PrEP).

5.

divisionofresearch.kaiserpermanente.org

divisionofresearch.kaiserpermanente.org/trial-reflects-challenges-of-expanding-hiv-prevention/

Decision support trial reflects challenges of expanding HIV ...

They found a slight but statistically insignificant increase in PrEP care initiation among doctors receiving the email prompts (6% vs. 4.5%).

6.

clinicalinfo.hiv.gov

clinicalinfo.hiv.gov/en/guidelines/perinatal/pre-exposure-prophylaxis-prep-prevent-hiv

Pre-exposure Prophylaxis (PrEP) to Prevent HIV During ...

In women with detectable drug levels (or taking PrEP), PrEP protected against 90% of incident transmissions.32,61 Newer observational data from ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9731791/

Usability and Utility of Human Immunodeficiency Virus Pre ...

Our findings suggest that an interruptive PrEP CDSS attached to HIV test orders can be an effective tool to increase knowledge and likelihood to initiate PrEP ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06805877

Study Details | NCT06805877 | Predictive Analytics and ...

The intervention will include automated EHR notifications to clinicians at 16 OCHIN community health centers about patients who are likely to benefit from PrEP.