Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
Intervention to Reduce Implicit Bias in Pharmacies
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
The Impact of an Intervention to Reduce Pharmacists Racial Bias Towards People of Color at Risk of HIV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This study will follow the ADAPT-ITT model to apply the Prejudice Habit Breaking Intervention PHBI to pharmacists who have experience with or are willing to prescribe PrEP We will first collect qualitative data through focus group discussions guided by the Health Equity Implementation Framework HEIF on determinants related to the intervention itself pharmacists and the community pharmacy context that may impact implementation of the PHBI Then we will use this information to adapt the PHBI in an iterative process involving topic experts pharmacists and PrEP users We will then determine the feasibility acceptability and preliminary impact of the adapted PHBI to reduce implicit racial bias
Detailed Description:
People of color POC accounted for nearly 70 of HIV new cases in the US in 2020 compared to 26 of new infections occurring among White individuals Significant further racial disparities exist in the PrEP care continuum For example per the US Center for Disease Control and Prevention 66 of White people eligible for PrEP received prescriptions compared to 26 of POC
To expand access to PrEP the role of the pharmacist in HIV care is increasing In the context of PrEP pharmacists may assess eligibility for PrEP initiate it monitor use and provide counseling Pharmacist-led PrEP clinics are growing in the US For example a pharmacy-based PrEP program in Washington succeeded in initiating PrEP for nearly 700 individuals of whom 74 started PrEP on the day of their initial appointment
Most health care providers including pharmacists have implicit racial bias in favor of White people A study among nearly 100 pharmacy students showed that two-thirds of them had racial biases against Black people PHBI is an effective intervention based on a solid scientific model of cognitive-behavioral change that teaches and trains individuals on multiple implicit bias mitigation strategies while respecting their autonomy and empowering them to sustain change efforts In comparison to numerous other implicit bias interventions that had only a transient impact the PHBI produced long-term effects in implicit bias measures Simulation-based learning has been shown to increase opportunities for repetitive deliberate practice including in pharmacy settings and can be applied to this intervention therefore it may be an ideal approach to practice anti-bias mitigation strategies within the PHBI thus advancing impact with potential for scalable implementation
Implicit racial bias represents a key barrier to achieving the expected benefits of pharmacist-led PrEP clinics to reduce disparities however no previous work has focused on this area While other barriers exist to PrEP uptake and use the proposed intervention could play a critical role in expanding PrEP access to POC We will adapt the intervention for pharmacists through use of the eight-phase ADAPT-ITT model We will use HEIF to identify determinants of intervention implementation We will then adapt the PHBI accordingly Finally we will test the adapted intervention in pharmacy interns recruited through the Bouvé College of Health Sciences in Boston Massachusetts We hypothesize that the adapted intervention will be acceptable and feasible with preliminary evidence of reduction in implicit racial bias We will randomize 70 pharmacy interns 11 in a pilot trial comparing the adapted intervention versus a control involving an online NIH course on implicit bias The trial outcomes will be acceptability and feasibility of the adapted PHBI as determined by mixed method interviews and process measures Preliminary impact of the intervention in reducing implicit racial bias will be assessed by the Race Implicit Association Test as an effectiveness outcome at 8 weeks post-intervention We will also qualitatively elicit feedback from 10 pharmacy managers and pharmacy policymakers on the trial findings
To expand access to PrEP the role of the pharmacist in HIV care is increasing In the context of PrEP pharmacists may assess eligibility for PrEP initiate it monitor use and provide counseling Pharmacist-led PrEP clinics are growing in the US For example a pharmacy-based PrEP program in Washington succeeded in initiating PrEP for nearly 700 individuals of whom 74 started PrEP on the day of their initial appointment
Most health care providers including pharmacists have implicit racial bias in favor of White people A study among nearly 100 pharmacy students showed that two-thirds of them had racial biases against Black people PHBI is an effective intervention based on a solid scientific model of cognitive-behavioral change that teaches and trains individuals on multiple implicit bias mitigation strategies while respecting their autonomy and empowering them to sustain change efforts In comparison to numerous other implicit bias interventions that had only a transient impact the PHBI produced long-term effects in implicit bias measures Simulation-based learning has been shown to increase opportunities for repetitive deliberate practice including in pharmacy settings and can be applied to this intervention therefore it may be an ideal approach to practice anti-bias mitigation strategies within the PHBI thus advancing impact with potential for scalable implementation
Implicit racial bias represents a key barrier to achieving the expected benefits of pharmacist-led PrEP clinics to reduce disparities however no previous work has focused on this area While other barriers exist to PrEP uptake and use the proposed intervention could play a critical role in expanding PrEP access to POC We will adapt the intervention for pharmacists through use of the eight-phase ADAPT-ITT model We will use HEIF to identify determinants of intervention implementation We will then adapt the PHBI accordingly Finally we will test the adapted intervention in pharmacy interns recruited through the Bouvé College of Health Sciences in Boston Massachusetts We hypothesize that the adapted intervention will be acceptable and feasible with preliminary evidence of reduction in implicit racial bias We will randomize 70 pharmacy interns 11 in a pilot trial comparing the adapted intervention versus a control involving an online NIH course on implicit bias The trial outcomes will be acceptability and feasibility of the adapted PHBI as determined by mixed method interviews and process measures Preliminary impact of the intervention in reducing implicit racial bias will be assessed by the Race Implicit Association Test as an effectiveness outcome at 8 weeks post-intervention We will also qualitatively elicit feedback from 10 pharmacy managers and pharmacy policymakers on the trial findings
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