Provider Training and Patient Education for HIV Prevention
(MOST:PrEP Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment involving provider training and patient education for HIV prevention?
Research shows that increasing provider knowledge about PrEP (a medication to prevent HIV) through education programs leads to higher rates of PrEP prescriptions and future intent to prescribe. Computer-based training has also been effective in improving HIV prevention knowledge among individuals at risk, suggesting that similar educational approaches can enhance the effectiveness of HIV prevention strategies.12345
Is simulation-based training safe for use in healthcare settings?
How does the treatment for HIV prevention differ from other treatments?
This treatment is unique because it combines provider training and patient education, including a computer-based simulation for providers and an informational video for patients, to enhance the understanding and use of PrEP (pre-exposure prophylaxis) for HIV prevention. Unlike traditional methods that focus solely on medication, this approach emphasizes education and training to improve the delivery and uptake of PrEP.3451112
What is the purpose of this trial?
What is known: There are 1.2 million people in the US who meet the indications for PrEP; yet, disparities exist in uptake. For example, only 9% of Black and 16% of Latino individuals, compared to 65% of White individuals, have been prescribed PrEP. At Henry Ford Health (HFH) system, only 10% of eligible patients have been prescribed PrEP. Primary care is an ideal setting for PrEP to be offered as an HIV prevention method since providers see large numbers of patients who are HIV negative, with some who are at increased risk for HIV, and the primary care setting is often the point of entry to the healthcare system. The multiphase optimization strategy (MOST) framework is a novel, innovative way to identify an efficient intervention. What will be done: In this optimization trial, the investigators will test the effectiveness of intervention components, alone and in combination, on new PrEP prescriptions in primary care at HFH. First, feedback will be generated on context-specific (system and individual level) factors for intervention component delivery via focus groups with providers (n=15) and patients eligible for PrEP (n=30). Then, four intervention components will be tested in an optimization trial, with 16 conditions being implemented at 32 clinics. Finally, feedback will be generated on the factors that affected implementation via semi-structured interviews with providers (n=30) and patients (n=30). Participants will be primary care providers (PCPs) and patients eligible for PrEP in Henry Ford Health System. Clinics will be randomized (yes/no) to receive any combination of provider and patient intervention components. Provider intervention components include computer-based simulation training and/or best practice alerts delivered via the electronic health record (EHR). Patient intervention components include HIV risk assessment and/or PrEP informational video - both delivered via the EHR. Primary outcome is the rate of new PrEP prescriptions at the clinic level. Secondary outcomes will include PrEP maintenance, number of HIV tests ordered by a PCP, and number of PCPs trained. Sub analyses will test which factors moderate (e.g., patient sex, race, age, gender, sexual orientation) or mediate (e.g., perceived HIV risk, provider and patient PrEP knowledge) PrEP uptake, focusing on priority populations and disparities in rates of PrEP prescription. Implications: 1) Understanding which intervention components lead to increased PrEP prescriptions will represent an important advance in HIV prevention efforts. 2) Optimizing a multi-level intervention for providers and patients to increase PrEP prescriptions would lead to a new, efficient, evidence-based option. 3) Determining what factors are related to PrEP uptake will help reduce disparities in PrEP initiation among those most in need. 4) Understanding the context specific factors related to intervention component implementation will help identify best methods for replication/adaptation in other healthcare systems.
Research Team
Elizabeth Lockhart, PhD
Principal Investigator
Henry Ford Health
Eligibility Criteria
This trial is for primary care providers and patients at Henry Ford Health System. Providers must be over 18, able to prescribe in Michigan, and work at HFH. Patients also need to be over 18, have an EHR account, see a HFH provider during the study, and meet criteria for PrEP but not already be on it or HIV positive.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention Feedback
Feedback generated on context-specific factors for intervention component delivery via focus groups with providers and patients
Optimization Trial
Testing of four intervention components in an optimization trial with 16 conditions implemented at 32 clinics
Implementation Feedback
Feedback generated on factors affecting implementation via semi-structured interviews with providers and patients
Follow-up
Participants are monitored for safety and effectiveness after intervention
Treatment Details
Interventions
- Best Practice Alert
- Computer-based simulation training for providers
- HIV Risk Assessment
- PrEP Informational Video
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor
New York University
Collaborator
University of South Florida
Collaborator