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

Official title

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

Overview

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.

Interventions

• 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-sim
• 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 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 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.

Primary outcome measures

• Clinic-Level PrEP Prescription [Time frame: Year 1 and Year 5 electronic health record data pull.]

Secondary outcome measures (6)

• PrEP Knowledge [Time frame: 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 prescribing comfort [Time frame: Pre-intervention and immediately after the intervention for providers]
• PrEP prescribing intentions [Time frame: Pre-intervention and immediately after the intervention for providers]
• Perceived HIV risk [Time frame: Patient demographic and 6- month surveys]
• Preferences for patient- provider communication [Time frame: Patient demographic and 6- month surveys]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Factorial

Masking

Double blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Henry Ford Health — Detroit

Identifiers

NCT: NCT06334341 · R01MD018523-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗