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NCT05991869 · ClinicalTrials.gov registry record · NA
Leveraging Electronic Health Record Data in a Risk Prediction Model to Increase HIV PrEP Intake in Primary Care
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 121
- Enrollment target
NCT05991869 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 121 participants.
The verdict
NCT05991869, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 121 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Point-of-care decision support intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2022-10-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05991869
The ClinicalTrials.gov registry entry for NCT05991869 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Point-of-care decision support intervention is the first listed.
NCT05991869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05991869 about?
NCT05991869 is a clinical study titled "Leveraging Electronic Health Record Data in a Risk Prediction Model to Increase HIV PrEP Intake in Primary Care". 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...
What is the current status of trial NCT05991869?
This trial is currently completed. It is a NA study. The enrollment target is 121 participants. The study started on 2021-06-01. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT05991869?
The interventions under investigation include: Point-of-care decision support intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05991869?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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