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

HIV Seropositivity Clinical Trial

— MOST:PrEP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06334341
• Other study ID #: R01MD018523-01A1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: April 2028

Study information

• Verified date: March 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1380
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Seropositivity

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Henry Ford Health	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Henry Ford Health System	New York University, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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