Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing

Not Applicable

Active, not recruiting

• Conditions: HIV

• Registration Number: NCT06805877
• Lead Sponsor: Harvard Pilgrim Health Care

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Study First Posted: 2025-02-03
• Status Verified: 2025-04
• Study Start: 2025-04-21
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Primary Completion: 2029-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PrEP initation	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 Outcome Measures

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

Trial Locations

Locations (16)

Bay Area Community Health Liberty Clinic; 🇺🇸 Fremont, California, United States

Lifelong East Oakland Health Center; 🇺🇸 Oakland, California, United States

TrueCare Oceanside Family Medicine; 🇺🇸 Oceanside, California, United States

DAP Legacy; 🇺🇸 Palm Springs, California, United States

One Community Health Midtown Campus; 🇺🇸 Sacramento, California, United States

Southwest Community Health Center 968 Fairfield Avenue; 🇺🇸 Bridgeport, Connecticut, United States

Mercy Care Decatur Street; 🇺🇸 Atlanta, Georgia, United States

Siouxland Community Health Center Sioux City; 🇺🇸 Sioux City, Iowa, United States

Lynn Community Health Center 269 Union; 🇺🇸 Lynn, Massachusetts, United States

Mattapan Community Health Center Blue Hill; 🇺🇸 Mattapan, Massachusetts, United States

Scroll for more (6 remaining)