Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing
PrEDICT
2 other identifiers
interventional
16
1 country
16
Brief Summary
Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the U.S. initiative to end the HIV epidemic, but healthcare providers lack tools to support PrEP discussions and prescribing for patients likely to benefit. This research will evaluate whether integrating automated tools into electronic health records to help providers efficiently and equitably identify potential candidates for PrEP, discuss PrEP, and prescribe PrEP can improve PrEP initiation and persistence in safety-net community health centers. It will achieve this by conducting a stepped-wedge trial of a decision support tool with an embedded HIV prediction model to identify patients likely to benefit from PrEP. The intervention will be delivered to healthcare providers in 16 community health centers within the national OCHIN network.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Apr 2025
Longer than P75 for not_applicable hiv
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2025
CompletedFirst Posted
Study publicly available on registry
February 3, 2025
CompletedStudy Start
First participant enrolled
April 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
April 24, 2025
April 1, 2025
4.2 years
January 28, 2025
April 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PrEP initation
Proportion of patients above the prediction model risk threshold without a recently active PrEP prescription (within the prior 6 months) or prior HIV diagnosis who are prescribed PrEP during the study period.
30 months
Secondary Outcomes (1)
PrEP persistence
30 months
Study Arms (2)
Standard of Care
NO INTERVENTIONData will be extracted from EHRs of control clinics as a comparison, and those clinics will not actively participate in study activities
Predictive analytics and clinical decision support
ACTIVE COMPARATORProviders in enrolled intervention clinics will receive point-of-care notifications via the EHR-embedded decision support tool about patients who are at increased predicted HIV risk and therefore likely to benefit from PrEP
Interventions
The intervention will include automated EHR notifications to clinicians at 16 OCHIN community health centers about patients who are likely to benefit from PrEP. These patients will be identified by an HIV prediction model that was developed and validated during the pilot phase of this study using historical OCHIN EHR data. For patients above a preselected threshold of predicted HIV risk, clinicians will be notified at the point of care that the patient may benefit from PrEP and will be provided with EHR-based tools to support discussions and prescribing. The intervention will also include coaching on PrEP and the decision support tool, as well as project team support during the trial period.
Eligibility Criteria
You may qualify if:
- Delivery site saw at least 500 distinct patients in 2024 during in-person or telehealth visits
- Delivery site had at least 10 new HIV diagnoses or positive HIV screening tests in 2023
- Delivery site provides primary care other than pediatrics, and the primary care department(s) were active on OCHIN Epic as of 1/1/2023
You may not qualify if:
- Delivery site specializing in HIV or STI care
- Correctional facilities
- Mobile sites
- School-based health center sites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard Pilgrim Health Carelead
- National Institute of Mental Health (NIMH)collaborator
- OCHIN, Inc.collaborator
- Oregon Health and Science Universitycollaborator
Study Sites (16)
Bay Area Community Health Liberty Clinic
Fremont, California, 94538, United States
Lifelong East Oakland Health Center
Oakland, California, 94605, United States
TrueCare Oceanside Family Medicine
Oceanside, California, 92054, United States
DAP Legacy
Palm Springs, California, 92262, United States
One Community Health Midtown Campus
Sacramento, California, 95811, United States
Southwest Community Health Center 968 Fairfield Avenue
Bridgeport, Connecticut, 06605, United States
Mercy Care Decatur Street
Atlanta, Georgia, 30312, United States
Siouxland Community Health Center Sioux City
Sioux City, Iowa, 51105, United States
Lynn Community Health Center 269 Union
Lynn, Massachusetts, 01901, United States
Mattapan Community Health Center Blue Hill
Mattapan, Massachusetts, 02126, United States
Neighborhood Family Practice Ridge Community Health Center
Cleveland, Ohio, 44102, United States
Signature Health Painesville
Painesville, Ohio, 44077, United States
Variety Care Sequoyah
Oklahoma City, Oklahoma, 73112, United States
Prism Belmont
Portland, Oregon, 97214, United States
Bee Busy Wellness Center Bray Oaks
Houston, Texas, 77031, United States
Seattle Roots Community Health Carolyn Downs Community Clinic
Seattle, Washington, 98122, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 28, 2025
First Posted
February 3, 2025
Study Start
April 21, 2025
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2030
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share