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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: Completed NA study, sponsored by Kaiser Permanente.
NCT05991869 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 121 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What the finished NCT05991869 record still lists
NCT05991869 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Point-of-care decision support intervention is the first listed.
NCT05991869 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05991869's enrollment target sits among peer trials
121 762nd of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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