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

NCT ID: NCT06334341

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-21

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Seropositivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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No intervention

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Video

Patient PrEP Video only

Group Type EXPERIMENTAL

PrEP Informational Video

Intervention Type BEHAVIORAL

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.

Risk Assessment

Patient Risk Assessment only

Group Type EXPERIMENTAL

HIV Risk Assessment

Intervention Type BEHAVIORAL

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.

Risk Assessment and Video

Patient Risk Assessment and Patient PrEP Video

Group Type EXPERIMENTAL

HIV Risk Assessment

Intervention Type BEHAVIORAL

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.

PrEP Informational Video

Intervention Type BEHAVIORAL

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.

Best Practice Alert

Best Practice Alert only

Group Type EXPERIMENTAL

Best Practice Alert

Intervention Type BEHAVIORAL

A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.

Best Practice Alert and Video

Best Practice Alert and Patient PrEP Video

Group Type EXPERIMENTAL

Best Practice Alert

Intervention Type BEHAVIORAL

A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.

PrEP Informational Video

Intervention Type BEHAVIORAL

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.

Best Practice Alert and Risk Assessment

Best Practice Alert and Patient Risk Assessment

Group Type EXPERIMENTAL

Best Practice Alert

Intervention Type BEHAVIORAL

A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.

Best Practice Alert, Risk Assessment and Video

Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video

Group Type EXPERIMENTAL

Best Practice Alert

Intervention Type BEHAVIORAL

A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.

HIV Risk Assessment

Intervention Type BEHAVIORAL

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.

PrEP Informational Video

Intervention Type BEHAVIORAL

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.

Training

Provider Training

Group Type EXPERIMENTAL

Computer-based simulation training for providers

Intervention Type BEHAVIORAL

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.

Training and Video

Provider Training and Patient PrEP Video

Group Type EXPERIMENTAL

Computer-based simulation training for providers

Intervention Type BEHAVIORAL

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.

PrEP Informational Video

Intervention Type BEHAVIORAL

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.

Training and Risk Assessment

Provider Training and Patient Risk Assessment

Group Type EXPERIMENTAL

Computer-based simulation training for providers

Intervention Type BEHAVIORAL

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.

HIV Risk Assessment

Intervention Type BEHAVIORAL

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.

Training, Risk Assessment, and Video

Provider Training, Patient Risk Assessment, and Patient PrEP Video

Group Type EXPERIMENTAL

Computer-based simulation training for providers

Intervention Type BEHAVIORAL

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.

HIV Risk Assessment

Intervention Type BEHAVIORAL

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.

PrEP Informational Video

Intervention Type BEHAVIORAL

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.

Training and Best Practice Alert

Provider Training and Best Practice Alert

Group Type EXPERIMENTAL

Computer-based simulation training for providers

Intervention Type BEHAVIORAL

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.

Best Practice Alert

Intervention Type BEHAVIORAL

A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.

Training, Best Practice Alert, and Video

Provider Training, Best Practice Alert, and Patient PrEP Video

Group Type EXPERIMENTAL

Computer-based simulation training for providers

Intervention Type BEHAVIORAL

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.

Best Practice Alert

Intervention Type BEHAVIORAL

A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.

PrEP Informational Video

Intervention Type BEHAVIORAL

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.

Training, Best Practice Alert, and Risk Assessment

Provider Training, Best Practice Alert, and Patient Risk Assessment

Group Type EXPERIMENTAL

Computer-based simulation training for providers

Intervention Type BEHAVIORAL

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.

Best Practice Alert

Intervention Type BEHAVIORAL

A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.

HIV Risk Assessment

Intervention Type BEHAVIORAL

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.

Training, Best Practice Alert, Risk Assessment, and Video

Provider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video

Group Type EXPERIMENTAL

Computer-based simulation training for providers

Intervention Type BEHAVIORAL

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.

Best Practice Alert

Intervention Type BEHAVIORAL

A Best Practice Alert will alert providers to patients who are part of the Centers for Disease Control and Prevention PrEP priority populations.

HIV Risk Assessment

Intervention Type BEHAVIORAL

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.

PrEP Informational Video

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Florida

OTHER

Sponsor Role collaborator

New York University

OTHER

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Lockhart

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Lockhart, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health

Locations

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Henry Ford Health

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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R01MD018523-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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