Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334341
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-28
First Post:
2024-03-18
Brief Title:
A Multilevel Multiphase Optimization Strategy for PrEP MOSTPrEP
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
A Multilevel Multiphase Optimization Strategy for PrEP Patients and Providers in Primary Care
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOSTPrEP
Brief Summary:
What is known There are 12 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 n15 and patients eligible for PrEP n30 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 n30 and patients n30 Participants will be primary care providers PCPs and patients eligible for PrEP in Henry Ford Health System Clinics will be randomized yesno to receive any combination of provider and patient intervention components Provider intervention components include computer-based simulation training andor best practice alerts delivered via the electronic health record EHR Patient intervention components include HIV risk assessment andor 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 eg patient sex race age gender sexual orientation or mediate eg 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 replicationadaptation in other healthcare systems
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None