Clinical Decision Support for PrEP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-11

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the federal initiative to end the HIV epidemic. However, healthcare providers lack tools to identify patients who are at increased risk for HIV infection and thus likely to benefit from PrEP. This pilot study will test the hypothesis that an electronic health record (EHR)-based clinical decision support system that incorporates an HIV risk prediction model can help providers identify patients at increased risk for HIV infection and improve PrEP prescribing in safety-net community health centers. The clinical decision support system will be implemented in the EHR at 2-3intervention clinics, while 2 control clinics will receive standard of care. The primary outcome is PrEP prescriptions. Other key metrics of PrEP-related care to be assessed include medication persistence, adherence to monitoring guidelines for PrEP, and rates of HIV/STI testing and diagnoses. The expected outcome is the foundation for a large-scale cluster randomized trial to test whether EHR-based clinical decision support tools for PrEP can improve PrEP prescribing and prevent new HIV infections in a national network of community health centers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing

NCT06805877

HIV

ACTIVE_NOT_RECRUITING NA

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

NCT05991869

Pre-Exposure Prophylaxis

COMPLETED NA

Optimizing HIV PrEP Through Shared Decision Making

NCT03019770

Pre-Exposure Prophylaxis

COMPLETED NA

Decision Support Tool to Integrate PrEP Into Emergency Departments

NCT07279129

HIV

NOT_YET_RECRUITING PHASE1

OPTIONS: A Patient-Centered HIV Prevention Decision Aid for PrEP Uptake for Women With Substance Use in Treatment Settings

NCT03651453

HIV Infections Substance Abuse

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections Preexposure Prophylaxis (PrEP)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The intervention will be implemented in 2-3 clinics, with 2-3 control clinics receiving standard of care. Eligible community health centers will be those with at least 500 patients and a minimum of 10 HIV diagnoses. Clinics located in counties identified as HIV hotspots will be prioritized. Clinics specializing in HIV or sexual health care, where providers may have less need for PrEP decision support, will be excluded. Overall, 26 clinics are expected to meet these eligibility criteria, with a total of 831 incident HIV diagnoses in 2018. Of eligible clinics, 2-3 will be recruited to receive the intervention. Using a covariate-constrained matching procedure with EHR data on important covariates (e.g., urbanity and the sex, race, and age distributions of the patient population), 2-3matched control clinics will be selected.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1 - Standard of care

Standard of care

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Two control clinics will be selected based on a set of matching criteria, e.g., urbanity and the sex, race, and age distributions of the patient population. Control clinics will not participate in study activities.

Arm 2 - Clinical decision support for PrEP

EHR-based decision support tools to support PrEP discussions and prescribing for patients who have increased predicted HIV risk

Group Type ACTIVE_COMPARATOR

Clinical decision support for PrEP

Intervention Type OTHER

Healthcare providers at 2 intervention clinics (total of approximately 60 providers anticipated) will be prompted by an EHR-based tool to discuss PrEP with patients whose demographics and clinical history indicate increased predicted HIV risk. Providers will be offered clinical decision support tools to guide sexual health discussions and support PrEP prescribing.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard of care

Two control clinics will be selected based on a set of matching criteria, e.g., urbanity and the sex, race, and age distributions of the patient population. Control clinics will not participate in study activities.

Intervention Type OTHER