PrEDICT: Clinical Decision Support for PrEP

Sponsor

Harvard Pilgrim Health Care (Other)

Overall Status

Recruiting

CT.gov ID

NCT05245201

Collaborator

OCHIN, Inc. (Other), Oregon Health and Science University (Other), National Institute of Mental Health (NIMH) (NIH), Beth Israel Deaconess Medical Center (Other)

Enrollment

Locations

Arms

21.7

Anticipated Duration (Months)

1.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Preexposure Prophylaxis (PrEP)	Other: Standard of care Other: Clinical decision support for PrEP	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 11, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 - Standard of care Standard of care	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.
Active Comparator: Arm 2 - Clinical decision support for PrEP EHR-based decision support tools to support PrEP discussions and prescribing for patients who have increased predicted HIV risk	Other: 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.

Arm

Intervention/Treatment

Active Comparator: Arm 1 - Standard of care

Standard of care

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.

Active Comparator: Arm 2 - Clinical decision support for PrEP

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

Other: 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.

Outcome Measures

Primary Outcome Measures

PrEP prescriptions [9 months]
Number of patients with increased predicted HIV risk who are prescribed PrEP

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saban Community Clinic	Los Angeles	California	United States	90038
2	Roanoke Chowan Community Health Center	Ahoskie	North Carolina	United States	27910
3	Kintegra Health	Gastonia	North Carolina	United States	28052

Sponsors and Collaborators

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

Investigators

Principal Investigator: Julia Marcus, PhD, Harvard Pilgrim Health Care Institute
Principal Investigator: Douglas Krakower, MD, Beth Israel Deaconess Medical Center