Clinical Decision Support for PrEP (PrEDICT)
Primary Purpose
HIV Infections, Preexposure Prophylaxis (PrEP)
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of care
Clinical decision support for PrEP
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, preexposure prophylaxis (PrEP), risk prediction, clinical decision support, electronic health records
Eligibility Criteria
Inclusion Criteria:
- Primary care providers at participating clinics who are licensed to prescribe PrEP
Exclusion Criteria:
- N/A
Sites / Locations
- Saban Community Clinic
- Roanoke Chowan Community Health Center
- Kintegra Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1 - Standard of care
Arm 2 - Clinical decision support for PrEP
Arm Description
Standard of care
EHR-based decision support tools to support PrEP discussions and prescribing for patients who have increased predicted HIV risk
Outcomes
Primary Outcome Measures
PrEP prescriptions
Number of patients with increased predicted HIV risk who are prescribed PrEP
Secondary Outcome Measures
Feasibility of clinical decision support system
Rates at which providers view alerts about patients with increased predicted HIV risk and rates at which providers access the EHR-based decision support tools using Epic date-time stamps
Acceptability of clinical decision support system
One-on-one feedback interviews with clinic administrators and 3-5 providers at intervention clinics
Full Information
NCT ID
NCT05245201
First Posted
January 19, 2022
Last Updated
August 15, 2023
Sponsor
Harvard Pilgrim Health Care
Collaborators
OCHIN, Inc., Oregon Health and Science University, National Institute of Mental Health (NIMH), Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05245201
Brief Title
Clinical Decision Support for PrEP
Acronym
PrEDICT
Official Title
Optimizing EHR-Based Prediction Models to Improve HIV Preexposure Prophylaxis Use in Community Health Centers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Harvard Pilgrim Health Care
Collaborators
OCHIN, Inc., Oregon Health and Science University, National Institute of Mental Health (NIMH), Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Preexposure Prophylaxis (PrEP)
Keywords
HIV, preexposure prophylaxis (PrEP), risk prediction, clinical decision support, electronic health records
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention will be implemented in 2-3 clinics, with 2-3 control clinics receiving standard of care. Eligible community health centers will be those with at least 500 patients and a minimum of 10 HIV diagnoses. Clinics located in counties identified as HIV hotspots will be prioritized. Clinics specializing in HIV or sexual health care, where providers may have less need for PrEP decision support, will be excluded. Overall, 26 clinics are expected to meet these eligibility criteria, with a total of 831 incident HIV diagnoses in 2018. Of eligible clinics, 2-3 will be recruited to receive the intervention. Using a covariate-constrained matching procedure with EHR data on important covariates (e.g., urbanity and the sex, race, and age distributions of the patient population), 2-3matched control clinics will be selected.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - Standard of care
Arm Type
Active Comparator
Arm Description
Standard of care
Arm Title
Arm 2 - Clinical decision support for PrEP
Arm Type
Active Comparator
Arm Description
EHR-based decision support tools to support PrEP discussions and prescribing for patients who have increased predicted HIV risk
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Two control clinics will be selected based on a set of matching criteria, e.g., urbanity and the sex, race, and age distributions of the patient population. Control clinics will not participate in study activities.
Intervention Type
Other
Intervention Name(s)
Clinical decision support for PrEP
Intervention Description
Healthcare providers at 2 intervention clinics (total of approximately 60 providers anticipated) will be prompted by an EHR-based tool to discuss PrEP with patients whose demographics and clinical history indicate increased predicted HIV risk. Providers will be offered clinical decision support tools to guide sexual health discussions and support PrEP prescribing.
Primary Outcome Measure Information:
Title
PrEP prescriptions
Description
Number of patients with increased predicted HIV risk who are prescribed PrEP
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Feasibility of clinical decision support system
Description
Rates at which providers view alerts about patients with increased predicted HIV risk and rates at which providers access the EHR-based decision support tools using Epic date-time stamps
Time Frame
6 months
Title
Acceptability of clinical decision support system
Description
One-on-one feedback interviews with clinic administrators and 3-5 providers at intervention clinics
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primary care providers at participating clinics who are licensed to prescribe PrEP
Exclusion Criteria:
N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Marcus, PhD
Organizational Affiliation
Harvard Pilgrim Health Care Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas Krakower, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saban Community Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90038
Country
United States
Facility Name
Roanoke Chowan Community Health Center
City
Ahoskie
State/Province
North Carolina
ZIP/Postal Code
27910
Country
United States
Facility Name
Kintegra Health
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28052
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Decision Support for PrEP
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