A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP)
MOST:PrEP
1 other identifier
interventional
1,380
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2024
CompletedFirst Submitted
Initial submission to the registry
March 18, 2024
CompletedFirst Posted
Study publicly available on registry
March 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
May 9, 2025
May 1, 2025
4.1 years
March 18, 2024
May 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinic-Level PrEP Prescription
The number of new PrEP prescriptions written within 6-months of the study-associated patient appointment. It is defined as a new documented prescription in the patient electronic health records for PrEP (daily pill or injection) at any date between the initial study primary care appointment plus 180 days.
Year 1 and Year 5 electronic health record data pull.
Secondary Outcomes (6)
PrEP Knowledge
Provider pre-post survey and patient demographic and 6- month surveys
PrEP awareness
Provider pre-post survey and patient demographic and 6- month surveys
PrEP prescribing comfort
Pre-intervention and immediately after the intervention for providers
PrEP prescribing intentions
Pre-intervention and immediately after the intervention for providers
Perceived HIV risk
Patient demographic and 6- month surveys
- +1 more secondary outcomes
Study Arms (16)
No intervention
NO INTERVENTIONNo intervention
Video
EXPERIMENTALPatient PrEP Video only
Risk Assessment
EXPERIMENTALPatient Risk Assessment only
Risk Assessment and Video
EXPERIMENTALPatient Risk Assessment and Patient PrEP Video
Best Practice Alert
EXPERIMENTALBest Practice Alert only
Best Practice Alert and Video
EXPERIMENTALBest Practice Alert and Patient PrEP Video
Best Practice Alert and Risk Assessment
EXPERIMENTALBest Practice Alert and Patient Risk Assessment
Best Practice Alert, Risk Assessment and Video
EXPERIMENTALBest Practice Alert, Patient Risk Assessment, and Patient PrEP Video
Training
EXPERIMENTALProvider Training
Training and Video
EXPERIMENTALProvider Training and Patient PrEP Video
Training and Risk Assessment
EXPERIMENTALProvider Training and Patient Risk Assessment
Training, Risk Assessment, and Video
EXPERIMENTALProvider Training, Patient Risk Assessment, and Patient PrEP Video
Training and Best Practice Alert
EXPERIMENTALProvider Training and Best Practice Alert
Training, Best Practice Alert, and Video
EXPERIMENTALProvider Training, Best Practice Alert, and Patient PrEP Video
Training, Best Practice Alert, and Risk Assessment
EXPERIMENTALProvider Training, Best Practice Alert, and Patient Risk Assessment
Training, Best Practice Alert, Risk Assessment, and Video
EXPERIMENTALProvider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
Interventions
A Computer-Based Simulation training for providers, based on the Centers for Disease Control and Prevention "Guide for Healthcare Professional: Discussing Sexual Health with Your Patients", current PrEP information, and the Social Cognitive Theory. This is a single-session, 30-minute training module contains educational information with animated narration about PrEP, how to take a sexual health history, understanding internal bias, potential patient barriers to PrEP as well as recorded video-simulated encounters, in which providers view different types of patient/provider interactions.
A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.
A risk assessment tool that considers the behaviors - i.e., types of sexual activities, protective behaviors (condoms, PrEP, ART), and other factors (HIV status, sexually transmitted infections) of the respondent.
A short informational video, tailored to the local Detroit context with themes that will focus on introducing PrEP, stigma surrounding taking PrEP, and potential barriers and how to overcome them.
Eligibility Criteria
You may qualify if:
- Provider:≥ 18-years old
- Provider: employed at HFH as a primary care provider
- Provider: eligible to write prescriptions in the state of Michigan
- Patient: ≥ 18 years old
- Patient: have an appointment with a Henry Ford primary care clinic during the study period
- Patient: have an EHR account
- Patient: meet the indications for PrEP
You may not qualify if:
- Provider: not a HFH primary care provider
- Provider: does not have prescribing privileges in the state of Michigan
- Patient: currently prescribed or taking PrEP
- Patient: living with HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henry Ford Health Systemlead
- University of South Floridacollaborator
- New York Universitycollaborator
Study Sites (1)
Henry Ford Health
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Lockhart, PhD
Henry Ford Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 18, 2024
First Posted
March 28, 2024
Study Start
February 21, 2024
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
May 9, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share