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OpenTrials
Active, Not Recruiting

NCT Number: NCT05245201

Clinical Decision Support for PrEP

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saban Community Clinic, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Standard of care

Other

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.

Clinical decision support for PrEP

Other

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 outcomes

  1. PrEP prescriptions

    Time frame: 9 months

    Number of patients with increased predicted HIV risk who are prescribed PrEP

Secondary outcomes

  1. Feasibility of clinical decision support system

    Time frame: 6 months

    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

  2. Acceptability of clinical decision support system

    Time frame: 6 months

    One-on-one feedback interviews with clinic administrators and 3-5 providers at intervention clinics

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • National Institute of Mental Health (NIMH)
  • OCHIN, Inc.
  • Oregon Health and Science University

Registry information

Official study title

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

Acronym: PrEDICT

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 17, 2022
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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