A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP) (MOST:PrEP)

A Multilevel, Multiphase Optimization Strategy for PrEP: Patients and Providers in Primary Care

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV Seropositivity
• Intervention / Treatment: Behavioral: PrEP Informational Video; Behavioral: HIV Risk Assessment; Behavioral: Best Practice Alert; Behavioral: Computer-based simulation training for providers

• Study Type: Interventional
• Enrollment (Estimated): 1380
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Experimental: Video; Patient PrEP Video only	Behavioral: PrEP Informational Video; 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.
Experimental: Risk Assessment; Patient Risk Assessment only	Behavioral: HIV Risk Assessment; 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.
Experimental: Risk Assessment and Video; Patient Risk Assessment and Patient PrEP Video	Behavioral: PrEP Informational Video; 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.; Behavioral: HIV Risk Assessment; 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.
Experimental: Best Practice Alert; Best Practice Alert only	Behavioral: Best Practice Alert; A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.
Experimental: Best Practice Alert and Video; Best Practice Alert and Patient PrEP Video	Behavioral: PrEP Informational Video; 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.; Behavioral: Best Practice Alert; A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.
Experimental: Best Practice Alert and Risk Assessment; Best Practice Alert and Patient Risk Assessment	Behavioral: Best Practice Alert; A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.
Experimental: Best Practice Alert, Risk Assessment and Video; Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video	Behavioral: PrEP Informational Video; 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.; Behavioral: HIV Risk Assessment; 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.; Behavioral: Best Practice Alert; A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.
Experimental: Training; Provider Training	Behavioral: Computer-based simulation training for providers; 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.
Experimental: Training and Video; Provider Training and Patient PrEP Video	Behavioral: PrEP Informational Video; 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.; Behavioral: Computer-based simulation training for providers; 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.
Experimental: Training and Risk Assessment; Provider Training and Patient Risk Assessment	Behavioral: HIV Risk Assessment; 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.; Behavioral: Computer-based simulation training for providers; 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.
Experimental: Training, Risk Assessment, and Video; Provider Training, Patient Risk Assessment, and Patient PrEP Video	Behavioral: PrEP Informational Video; 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.; Behavioral: HIV Risk Assessment; 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.; Behavioral: Computer-based simulation training for providers; 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.
Experimental: Training and Best Practice Alert; Provider Training and Best Practice Alert	Behavioral: Best Practice Alert; A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.; Behavioral: Computer-based simulation training for providers; 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.
Experimental: Training, Best Practice Alert, and Video; Provider Training, Best Practice Alert, and Patient PrEP Video	Behavioral: PrEP Informational Video; 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.; Behavioral: Best Practice Alert; A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.; Behavioral: Computer-based simulation training for providers; 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.
Experimental: Training, Best Practice Alert, and Risk Assessment; Provider Training, Best Practice Alert, and Patient Risk Assessment	Behavioral: HIV Risk Assessment; 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.; Behavioral: Best Practice Alert; A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.; Behavioral: Computer-based simulation training for providers; 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.
Experimental: Training, Best Practice Alert, Risk Assessment, and Video; Provider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video	Behavioral: PrEP Informational Video; 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.; Behavioral: HIV Risk Assessment; 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.; Behavioral: Best Practice Alert; A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.; Behavioral: Computer-based simulation training for providers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Knowledge	PrEP knowledge will be measured by 6-items assessing PrEP dosing frequency, approved FDA medications, HIV antibody testing prior to PrEP initiation, HIV testing frequency while on PrEP, contraindications to prescribing PrEP, and routine standard of care practices for patients taking PrEP	Provider pre-post survey and patient demographic and 6- month surveys
PrEP awareness	PrEP awareness will be measured by the statement "there is a pill (drug/medication) that a person can take to prevent transmission of HIV from an infected (HIV positive) sex partner to an uninfected (HIV negative) partner." with responses true/false, don't know.	Provider pre-post survey and patient demographic and 6- month surveys
PrEP prescribing comfort	PrEP prescribing comfort will be measured by 9- items from the PrEP Information, Motivation, and Behaviors survey.	Pre-intervention and immediately after the intervention for providers
PrEP prescribing intentions	PrEP prescribing intentions will be measured by 8- items from the PrEP Information, Motivation, and Behaviors survey.	Pre-intervention and immediately after the intervention for providers
Perceived HIV risk	Patients perceived HIV risk will be measured by 10- items from the Perceived Risk of HIV scale.	Patient demographic and 6- month surveys
Preferences for patient- provider communication	Preferences for patient-provider communications will be measured by the Control Preferences Scale, the Communication Assessment Tool, and the Patient-Practitioner Orientation Scale.	Patient demographic and 6- month surveys

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: University of South Florida; New York University
• Investigators: Principal Investigator: Elizabeth Lockhart, PhD, Henry Ford Health

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Preexposure Prophylaxis
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Urogenital Diseases; Genital Diseases; HIV Seropositivity
• Other Study ID Numbers: R01MD018523-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No