Clinical Decision Support for PrEP

HIV Infections Clinical Trial

— PrEDICT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05245201
• Other study ID #: PH000739A
• Secondary ID: R34MH122291
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• 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.
• Clinical decision support for PrEP
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.

Locations

Country	Name	City	State
United States	Roanoke Chowan Community Health Center	Ahoskie	North Carolina
United States	Kintegra Health	Gastonia	North Carolina
United States	Saban Community Clinic	Los Angeles	California

Sponsors (5)

Lead Sponsor	Collaborator
Harvard Pilgrim Health Care	Beth Israel Deaconess Medical Center, National Institute of Mental Health (NIMH), OCHIN, Inc., Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP prescriptions	Number of patients with increased predicted HIV risk who are prescribed PrEP	9 months
Secondary	Feasibility of clinical decision support system	Rates at which providers view alerts about patients with increased predicted HIV risk and rates at which providers access the EHR-based decision support tools using Epic date-time stamps	6 months
Secondary	Acceptability of clinical decision support system	One-on-one feedback interviews with clinic administrators and 3-5 providers at intervention clinics	6 months