Clinical Decision Support for PrEP (PrEDICT)

Harvard Pilgrim Health Care

Status: Active, not recruiting

Conditions: Preexposure Prophylaxis (PrEP); HIV Infections

Treatments: Other: Clinical decision support for PrEP; Other: Standard of care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05245201

PH000739A

R34MH122291 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 4 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• N/A

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Arm 1 - Standard of care

Active Comparator group

Description:

Standard of care

Treatment:

Other: Standard of care

Arm 2 - Clinical decision support for PrEP

Active Comparator group

Description:

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

Treatment:

Other: Clinical decision support for PrEP