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HIV SeropositivityMOST:PrEPNCT06334341

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

A study testing Computer-based simulation training for providers, Best Practice Alert and HIV Risk Assessment in people with HIV Seropositivity, run by Henry Ford Health System at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Seropositivity
What is being tested?
Computer-based simulation training for providers, Best Practice Alert and HIV Risk Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,380 participants
Where
1 siteUnited States
Study dates
19 Jun 2024to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Henry Ford Health

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: 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.

Read the detailed description

Inclusion criteria for provider participants are: 1) ≥ 18-years old; 2) employed at HFH in primary care, family medicine, or internal medicine; 3) eligible to write prescriptions in the state of MI.

Inclusion criteria for patient participants are: 1) ≥ 18 years old; 2) have an appointment with a Henry Ford primary care clinic during the study period; 3) have an electronic health record (EHR) account; 4) eligible for PrEP prescription.

Exclusion criteria for providers are: 1) not a HFH primary care provider; 2) does not have prescribing privileges in the state of Michigan.

Exclusion criteria for patient participants include: 1) currently prescribed or taking PrEP; 2) living with HIV.

Being tested
Computer-based simulation training for providers, Best Practice Alert, HIV Risk Assessment, PrEP Informational Video
Keywords
Preexposure Prophylaxis
Medical subject headings
HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computer-based simulation training for providersBehavioural

    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 AlertBehavioural

    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 AssessmentBehavioural

    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 VideoBehavioural

    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.

Study groups in NCT06334341
Study groupRoleWhat they receive
No interventionNo interventionNo intervention
VideoExperimentalPatient PrEP Video only
Receives: Behavioral: PrEP Informational Video
Risk AssessmentExperimentalPatient Risk Assessment only
Receives: Behavioral: HIV Risk Assessment
Risk Assessment and VideoExperimentalPatient Risk Assessment and Patient PrEP Video
Receives: Behavioral: HIV Risk Assessment; Behavioral: PrEP Informational Video
Best Practice AlertExperimentalBest Practice Alert only
Receives: Behavioral: Best Practice Alert
Best Practice Alert and VideoExperimentalBest Practice Alert and Patient PrEP Video
Receives: Behavioral: Best Practice Alert; Behavioral: PrEP Informational Video
Best Practice Alert and Risk AssessmentExperimentalBest Practice Alert and Patient Risk Assessment
Receives: Behavioral: Best Practice Alert
Best Practice Alert, Risk Assessment and VideoExperimentalBest Practice Alert, Patient Risk Assessment, and Patient PrEP Video
Receives: Behavioral: Best Practice Alert; Behavioral: HIV Risk Assessment; Behavioral: PrEP Informational Video
TrainingExperimentalProvider Training
Receives: Behavioral: Computer-based simulation training for providers
Training and VideoExperimentalProvider Training and Patient PrEP Video
Receives: Behavioral: Computer-based simulation training for providers; Behavioral: PrEP Informational Video
Training and Risk AssessmentExperimentalProvider Training and Patient Risk Assessment
Receives: Behavioral: Computer-based simulation training for providers; Behavioral: HIV Risk Assessment
Training, Risk Assessment, and VideoExperimentalProvider Training, Patient Risk Assessment, and Patient PrEP Video
Receives: Behavioral: Computer-based simulation training for providers; Behavioral: HIV Risk Assessment; Behavioral: PrEP Informational Video
Training and Best Practice AlertExperimentalProvider Training and Best Practice Alert
Receives: Behavioral: Computer-based simulation training for providers; Behavioral: Best Practice Alert
Training, Best Practice Alert, and VideoExperimentalProvider Training, Best Practice Alert, and Patient PrEP Video
Receives: Behavioral: Computer-based simulation training for providers; Behavioral: Best Practice Alert; Behavioral: PrEP Informational Video
Training, Best Practice Alert, and Risk AssessmentExperimentalProvider Training, Best Practice Alert, and Patient Risk Assessment
Receives: Behavioral: Computer-based simulation training for providers; Behavioral: Best Practice Alert; Behavioral: HIV Risk Assessment
Training, Best Practice Alert, Risk Assessment, and VideoExperimentalProvider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
Receives: Behavioral: Computer-based simulation training for providers; Behavioral: Best Practice Alert; Behavioral: HIV Risk Assessment; Behavioral: PrEP Informational Video

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Year 1 and Year 5 electronic health record data pull.

Secondary outcomes (4)
  1. 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

    Measured: Provider pre-post survey and patient demographic and 6- month surveys

  2. 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.

    Measured: Provider pre-post survey and patient demographic and 6- month surveys

  3. PrEP prescribing comfort

    PrEP prescribing comfort will be measured by 9- items from the PrEP Information, Motivation, and Behaviors survey.

    Measured: Pre-intervention and immediately after the intervention for providers

  4. PrEP prescribing intentions

    PrEP prescribing intentions will be measured by 8- items from the PrEP Information, Motivation, and Behaviors survey.

    Measured: Pre-intervention and immediately after the intervention for providers

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2024
  2. Study start19 Jun 2024
  3. Primary completion3 Apr 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
1,380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06334341
Sponsor's protocol ID
R01MD018523-01A1
Acronym
MOST:PrEP
Status last verified
May 2026
First submitted
18 Mar 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Computer-based simulation training for providers, Best Practice Alert and HIV Risk Assessment in people with HIV Seropositivity, run by Henry Ford Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinic-Level PrEP Prescription (time frame: Year 1 and Year 5 electronic health record data pull.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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