Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing (PrEDICT)

Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing in Community Health Centers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV
• Intervention / Treatment: Other: Predictive Analytics and Clinical Decision Support

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Bay Area Community Health Liberty Clinic
    • Oakland, California, United States, 94605
      • Lifelong East Oakland Health Center
    • Oceanside, California, United States, 92054
      • TrueCare Oceanside Family Medicine
    • Palm Springs, California, United States, 92262
      • DAP Legacy
    • Sacramento, California, United States, 95811
      • One Community Health Midtown Campus
  • Connecticut
    • Bridgeport, Connecticut, United States, 06605
      • Southwest Community Health Center 968 Fairfield Avenue
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Mercy Care Decatur Street
  • Iowa
    • Sioux City, Iowa, United States, 51105
      • Siouxland Community Health Center Sioux City
  • Massachusetts
    • Lynn, Massachusetts, United States, 01901
      • Lynn Community Health Center 269 Union
    • Mattapan, Massachusetts, United States, 02126
      • Mattapan Community Health Center Blue Hill
  • Ohio
    • Cleveland, Ohio, United States, 44102
      • Neighborhood Family Practice Ridge Community Health Center
    • Painesville, Ohio, United States, 44077
      • Signature Health Painesville
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Variety Care Sequoyah
  • Oregon
    • Portland, Oregon, United States, 97214
      • Prism Belmont
  • Texas
    • Houston, Texas, United States, 77031
      • Bee Busy Wellness Center Bray Oaks
  • Washington
    • Seattle, Washington, United States, 98122
      • Seattle Roots Community Health Carolyn Downs Community Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Delivery site specializing in HIV or STI care
• Correctional facilities
• Mobile sites
• School-based health center sites

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Data will be extracted from EHRs of control clinics as a comparison, and those clinics will not actively participate in study activities
Active Comparator: Predictive analytics and clinical decision support; Providers 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	Other: Predictive Analytics and Clinical Decision Support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP persistence	Proportion of patients prescribed PrEP who persist on PrEP for 6 and 12 months, as measured by prescription refills ordered.	30 months

Collaborators and Investigators

• Sponsor: Harvard Pilgrim Health Care
• Collaborators: National Institute of Mental Health (NIMH); Oregon Health and Science University; OCHIN, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: HIV; PrEP; prevention; clinical decision support; prediction model; pre-exposure prophylaxis
• Other Study ID Numbers: PH001008; R01MH133515 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No