Clinical Decision Support for PrEP

Not Applicable

Active, not recruiting

• Conditions: Preexposure Prophylaxis (PrEP); HIV Infections
• Interventions: Other: Clinical decision support for PrEP; Other: Standard of care

• Registration Number: NCT05245201
• Lead Sponsor: Harvard Pilgrim Health Care

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-17
• Study Start: 2022-07-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 - Clinical decision support for PrEP	Clinical decision support for PrEP	EHR-based decision support tools to support PrEP discussions and prescribing for patients who have increased predicted HIV risk
Arm 1 - Standard of care	Standard of care	Standard of care

Primary Outcome Measures

Name	Time	Method
PrEP prescriptions	9 months	Number of patients with increased predicted HIV risk who are prescribed PrEP

Secondary Outcome Measures

Name	Time	Method
Feasibility of clinical decision support system	6 months	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
Acceptability of clinical decision support system	6 months	One-on-one feedback interviews with clinic administrators and 3-5 providers at intervention clinics

Trial Locations

Locations (3)

Saban Community Clinic; 🇺🇸 Los Angeles, California, United States

Roanoke Chowan Community Health Center; 🇺🇸 Ahoskie, North Carolina, United States

Kintegra Health; 🇺🇸 Gastonia, North Carolina, United States