An interventional study of Computer-based simulation training for providers and Best Practice Alert in HIV Seropositivity, sponsored by Henry Ford Health System. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Prevention
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.
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.
194 studies on the registry are indexed under HIV Seropositivity; 11 are open to participants now.
This study's planned enrollment of 1,380 is above the median of 105 across 114 interventional studies indexed under HIV Seropositivity.
Browse HIV Seropositivity studies →Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
Patient PrEP Video only
Behavioral: PrEP Informational Video
Patient Risk Assessment only
Behavioral: HIV Risk Assessment
Patient Risk Assessment and Patient PrEP Video
Behavioral: HIV Risk Assessment · Behavioral: PrEP Informational Video
Best Practice Alert only
Behavioral: Best Practice Alert
Best Practice Alert and Patient PrEP Video
Behavioral: Best Practice Alert · Behavioral: PrEP Informational Video
Best Practice Alert and Patient Risk Assessment
Behavioral: Best Practice Alert
Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
Behavioral: Best Practice Alert · Behavioral: HIV Risk Assessment · Behavioral: PrEP Informational Video
Provider Training
Behavioral: Computer-based simulation training for providers
Provider Training and Patient PrEP Video
Behavioral: Computer-based simulation training for providers · Behavioral: PrEP Informational Video
Provider Training and Patient Risk Assessment
Behavioral: Computer-based simulation training for providers · Behavioral: HIV Risk Assessment
Provider Training, Patient Risk Assessment, and Patient PrEP Video
Behavioral: Computer-based simulation training for providers · Behavioral: HIV Risk Assessment · Behavioral: PrEP Informational Video
Provider Training and Best Practice Alert
Behavioral: Computer-based simulation training for providers · Behavioral: Best Practice Alert
Provider Training, Best Practice Alert, and Patient PrEP Video
Behavioral: Computer-based simulation training for providers · Behavioral: Best Practice Alert · Behavioral: PrEP Informational Video
Provider Training, Best Practice Alert, and Patient Risk Assessment
Behavioral: Computer-based simulation training for providers · Behavioral: Best Practice Alert · Behavioral: HIV Risk Assessment
Provider Training, Best Practice Alert, Patient Risk Assessment, and Patient PrEP Video
Behavioral: Computer-based simulation training for providers · Behavioral: Best Practice Alert · Behavioral: HIV Risk Assessment · Behavioral: PrEP Informational Video
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.
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.
Time frame: Year 1 and Year 5 electronic health record data pull.
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-intervention and immediately after the intervention for providers
Started Jun 2024 (actual). Primary completion is estimated for Apr 2028, 45 months after the start.
Of 28 non-industry interventional studies with no phase under HIV Seropositivity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's planned 45 months is above that.
Counting every sponsor, half of 29 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
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