Clinical Decision Support for PrEP (PrEDICT)

Optimizing EHR-Based Prediction Models to Improve HIV Preexposure Prophylaxis Use in Community Health Centers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections; Preexposure Prophylaxis (PrEP)
• Intervention / Treatment: Other: Standard of care; Other: Clinical decision support for PrEP

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90038
      • Saban Community Clinic
  • North Carolina
    • Ahoskie, North Carolina, United States, 27910
      • Roanoke Chowan Community Health Center
    • Gastonia, North Carolina, United States, 28052
      • Kintegra Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Primary care providers at participating clinics who are licensed to prescribe PrEP

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 - Standard of care; Standard of care	Other: Standard of care; 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.
Active Comparator: Arm 2 - Clinical decision support for PrEP; EHR-based decision support tools to support PrEP discussions and prescribing for patients who have increased predicted HIV risk	Other: Clinical decision support for PrEP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP prescriptions	Number of patients with increased predicted HIV risk who are prescribed PrEP	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
Acceptability of clinical decision support system	One-on-one feedback interviews with clinic administrators and 3-5 providers at intervention clinics	6 months

Collaborators and Investigators

• Sponsor: Harvard Pilgrim Health Care
• Collaborators: National Institute of Mental Health (NIMH); Beth Israel Deaconess Medical Center; Oregon Health and Science University; OCHIN, Inc.
• Investigators: Principal Investigator: Julia Marcus, PhD, Harvard Pilgrim Health Care Institute; Principal Investigator: Douglas Krakower, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: HIV; clinical decision support; electronic health records; risk prediction; preexposure prophylaxis (PrEP)
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: PH000739A; R34MH122291 (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