Clinical trial NCT05245201: Clinical Decision Support for PrEP
Official title: Optimizing EHR-Based Prediction Models to Improve HIV Preexposure Prophylaxis Use in Community Health Centers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Preexposure Prophylaxis (PrEP)
Keywords: HIV
preexposure prophylaxis (PrEP)
risk prediction
clinical decision support
electronic health records
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: OCHIN, Inc.
name: Oregon Health and Science University
name: National Institute of Mental Health (NIMH)
name: Beth Israel Deaconess Medical Center
First posted: 2022-02-17
Enrollment: 4
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Primary care providers at participating clinics who are licensed to prescribe PrEP

Exclusion Criteria:

* N/A

Primary outcomes:
measure: PrEP prescriptions
timeFrame: 9 months
Secondary outcomes:
measure: Feasibility of clinical decision support system
timeFrame: 6 months
measure: Acceptability of clinical decision support system
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Saban Community Clinic
state: California
city: Ahoskie
country: United States
facility: Roanoke Chowan Community Health Center
state: North Carolina
city: Gastonia
country: United States
facility: Kintegra Health
state: North Carolina
Study officials:
affiliation: Harvard Pilgrim Health Care Institute
name: Julia Marcus, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Douglas Krakower, MD
role: PRINCIPAL_INVESTIGATOR
References: