Clinical trial NCT06805877: Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing
Official title: Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing in Community Health Centers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Keywords: HIV
PrEP
pre-exposure prophylaxis
prevention
prediction model
clinical decision support
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: OCHIN, Inc.
name: Oregon Health and Science University
First posted: 2025-02-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: PrEP initation
timeFrame: 30 months
Secondary outcomes:
measure: PrEP persistence
timeFrame: 30 months
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Bay Area Community Health Liberty Clinic
state: California
city: Oakland
country: United States
facility: Lifelong East Oakland Health Center
state: California
city: Oceanside
country: United States
facility: TrueCare Oceanside Family Medicine
state: California
city: Palm Springs
country: United States
facility: DAP Legacy
state: California
city: Sacramento
country: United States
facility: One Community Health Midtown Campus
state: California
city: Bridgeport
country: United States
facility: Southwest Community Health Center 968 Fairfield Avenue
state: Connecticut
city: Atlanta
country: United States
facility: Mercy Care Decatur Street
state: Georgia
city: Sioux City
country: United States
facility: Siouxland Community Health Center Sioux City
state: Iowa
city: Lynn
country: United States
facility: Lynn Community Health Center 269 Union
state: Massachusetts
city: Mattapan
country: United States
facility: Mattapan Community Health Center Blue Hill
state: Massachusetts
city: Cleveland
country: United States
facility: Neighborhood Family Practice Ridge Community Health Center
state: Ohio
city: Painesville
country: United States
facility: Signature Health Painesville
state: Ohio
city: Oklahoma City
country: United States
facility: Variety Care Sequoyah
state: Oklahoma
city: Portland
country: United States
facility: Prism Belmont
state: Oregon
city: Houston
country: United States
facility: Bee Busy Wellness Center Bray Oaks
state: Texas
city: Seattle
country: United States
facility: Seattle Roots Community Health Carolyn Downs Community Clinic
state: Washington
Study officials:
References: