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

May 6, 2025 updated by: Elizabeth Lockhart, Henry Ford Health System

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1380

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinic-Level PrEP Prescription
Time Frame: Year 1 and Year 5 electronic health record data pull.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PrEP Knowledge
Time Frame: Provider pre-post survey and patient demographic and 6- month surveys
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
Time Frame: Provider pre-post survey and patient demographic and 6- month surveys
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
Time Frame: Pre-intervention and immediately after the intervention for providers
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
Time Frame: Pre-intervention and immediately after the intervention for providers
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
Time Frame: Patient demographic and 6- month surveys
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
Time Frame: Patient demographic and 6- month surveys
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henry Ford Health System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of South Florida
New York University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Lockhart, PhD, Henry Ford Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MD018523-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

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