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Clinical Trials/NCT05245201
NCT05245201
Active, not recruiting
Not Applicable

Optimizing EHR-Based Prediction Models to Improve HIV Preexposure Prophylaxis Use in Community Health Centers

Harvard Pilgrim Health Care3 sites in 1 country4 target enrollmentJuly 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Harvard Pilgrim Health Care
Enrollment
4
Locations
3
Primary Endpoint
PrEP prescriptions
Status
Active, not recruiting
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 11, 2022
End Date
August 1, 2027
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

PrEP prescriptions

Time Frame: 9 months

Number of patients with increased predicted HIV risk who are prescribed PrEP

Secondary Outcomes

  • Feasibility of clinical decision support system(6 months)
  • Acceptability of clinical decision support system(6 months)

Study Sites (3)

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