Clinical Decision Support for PrEP

NCT05245201 | Active Not Recruiting

• 2 other identifiers: PH000739AR34MH122291
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infections; Preexposure Prophylaxis (PrEP)

Keywords

HIV; preexposure prophylaxis (PrEP); risk prediction; clinical decision support; electronic health records

Outcome Measures

Primary Outcomes (1)

• PrEP prescriptions

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

  9 months

Secondary Outcomes (2)

• Feasibility of clinical decision support system

  6 months

• Acceptability of clinical decision support system

  6 months

Study Arms (2)

Arm 1 - Standard of care

ACTIVE COMPARATOR

Standard of care

Other: Standard of care

Arm 2 - Clinical decision support for PrEP

ACTIVE COMPARATOR

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

Interventions

Standard of care OTHER

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.

Arm 1 - Standard of care

Clinical decision support for PrEP OTHER

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 2 - Clinical decision support for PrEP

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

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

Study Sites (3)

Saban Community Clinic

Los Angeles, California, 90038, United States

Location

Roanoke Chowan Community Health Center

Ahoskie, North Carolina, 27910, United States

Location

Kintegra Health

Gastonia, North Carolina, 28052, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Julia Marcus, PhD

  Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

• Douglas Krakower, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 17, 2022
• Study Start: July 11, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)