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Active, Not Recruiting

NCT Number: NCT06805877

Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bay Area Community Health Liberty Clinic, Fremont, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Predictive Analytics and Clinical Decision Support

Other

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.

Primary outcomes

  1. PrEP initation

    Time frame: 30 months

    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.

Secondary outcomes

  1. PrEP persistence

    Time frame: 30 months

    Proportion of patients prescribed PrEP who persist on PrEP for 6 and 12 months, as measured by prescription refills ordered.

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • OCHIN, Inc.
  • Oregon Health and Science University

Registry information

Official study title

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

Acronym: PrEDICT

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Feb 3, 2025
Registry last updated
Apr 24, 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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