Leveraging Electronic Health Record Data in a Risk Prediction Model to Increase HIV PrEP Intake in Primary Care

NCT05991869 | Completed

• 1 other identifier: DelSciPrEP 2021
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

Kaiser Permanente Northern California (KPNC) has been a national leader in implementation of HIV preexposure prophylaxis (PrEP), a daily antiretroviral pill that is more than 99% effective in preventing HIV acquisition. However, many patients at risk for HIV at KPNC are not yet using PrEP, resulting in preventable infections each year. In prior work, the study team developed and validated a prediction model that used electronic health record (EHR) data from 3.7 million KPNC members to identify patients at high risk of HIV acquisition but not using PrEP. The model substantially outperformed models based only on CDC criteria for PrEP use, particularly for Black patients, a population with high HIV incidence and lower PrEP uptake. The objective of this proposal is to evaluate the feasibility of implementing this EHR-based model at the point of care to increase PrEP referrals and uptake at KPNC. The specific aims of this project are to 1) conduct provider focus groups to identify barriers and facilitators to PrEP referrals and to optimize the delivery mechanism of our clinical decision support intervention, 2) evaluate the feasibility and acceptability of a clinical decision support intervention for primary care providers (PCPs) to increase PrEP referrals and uptake among high-risk patients, and 3) assess patient- and provider-based characteristics associated with PrEP referrals and uptake. To accomplish these aims, the study team proposes a randomized controlled trial of a clinical decision support intervention for PrEP, which involves alerting KP San Francisco (KPSF) Adult and Family Medicine PCPs about patients identified by our prediction model as being at high risk for HIV acquisition prior to in-person clinic visits. We will compare PrEP referrals and uptake among patients who are seen by PCPs randomized to intervention and usual care study arms using an intention-to-treat analysis.

Conditions

Pre-Exposure Prophylaxis

Keywords

HIV; Pre-Exposure Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Cumulative risk (%) of linkage to PrEP

  linkage to PrEP care within 90 days of the first encounter, defined as first of following: PrEP discussion (ICD-10 Z29.8), referral (measured by PrEP referrals and appointments booked through e-consult, a provider-to-provider community platform embedded in the EHR ), or prescription fill for emtricitabine coformulated with tenofovir disoproxil fumarate or with tenofovir alafenamide

  Within 90 days after PrEP referral.

Secondary Outcomes (3)

• Cumulative risk (%) of PrEP Prescription fill only

  Within 90 days after first encounter

• Cumulative risk (%) of HIV Testing

  within 90 days of first encounter

• Cumulative risk (%) of STI Testing

  within 90 days of first encounter

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Point-of-care decision support intervention

Usual Care

NO INTERVENTION

Interventions

Point-of-care decision support intervention BEHAVIORAL

PCPs notified by EHR messages if they had an upcoming in-person or video visit with an eligible patient who had a predicted risk of incident HIV diagnosis of 0.2% or higher. Study team members manually sent messages marked as "high priority" one business day prior to scheduled visits, alerting PCPs that a patient may be at increased risk for acquiring HIV and may benefit from a conversation about PrEP. Additional information was provided about the study, the prediction model, clinical indications for PrEP, strategies for initiating discussions about HIV prevention and PrEP, and how to refer patients to KPSF's PrEP program. Messages did not include the numeric predicted HIV risk from the model. PCPs received a maximum of two messages per day; with the two patients with the highest predicted risk were selected. Patient with multiple visits were flagged no more than once monthly.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care provider at Kaiser Permanente San Francisco Medical Center
• Provide primary care to adult patients
• more than 150 people without HIV on their primary care physician panel.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Northern California Division of Research

Oakland, California, 94612, United States

Location

Related Publications (1)

• Volk JE, Leyden WA, Lea AN, Lee C, Donnelly MC, Krakower DS, Lee K, Liu VX, Marcus JL, Silverberg MJ. Using Electronic Health Records to Improve HIV Preexposure Prophylaxis Care: A Randomized Trial. J Acquir Immune Defic Syndr. 2024 Apr 1;95(4):362-369. doi: 10.1097/QAI.0000000000003376.

  PMID: 38412047 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 15, 2023
• Study Start: June 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: October 31, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)