Clinical trial NCT06334341: A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP)
Official title: A Multilevel, Multiphase Optimization Strategy for PrEP: Patients and Providers in Primary Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: HIV Seropositivity
Keywords: Preexposure Prophylaxis
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: New York University
First posted: 2024-03-28
Enrollment: 1380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: Clinic-Level PrEP Prescription
timeFrame: Year 1 and Year 5 electronic health record data pull.
Secondary outcomes:
measure: PrEP Knowledge
timeFrame: Provider pre-post survey and patient demographic and 6- month surveys
measure: PrEP awareness
timeFrame: Provider pre-post survey and patient demographic and 6- month surveys
measure: PrEP prescribing comfort
timeFrame: Pre-intervention and immediately after the intervention for providers
measure: PrEP prescribing intentions
timeFrame: Pre-intervention and immediately after the intervention for providers
measure: Perceived HIV risk
timeFrame: Patient demographic and 6- month surveys
measure: Preferences for patient- provider communication
timeFrame: Patient demographic and 6- month surveys
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
Study officials:
affiliation: Henry Ford Health
name: Elizabeth Lockhart, PhD
role: PRINCIPAL_INVESTIGATOR
References: