Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Location contact
Jessica Haberer
CONTACT
NCT Number: NCT06487351
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
Jessica Haberer
CONTACT
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 1:1 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Three types of participants will be included
Exclusion criteria
Inability to provide consent (e.g., intoxication), unwillingness to provide consent
The adapted intervention is expected to be an online 60-minute video with an educational part about implicit racial bias, its consequences in healthcare inequalities, how to mitigate it, and seven case scenarios (5 minutes each) to train pharmacy interns on aspects related to cultural competency and how and when to use IBMS to reduce the impact of bias on prescribing PrEP for people of color.
The NIH Implicit Bias course consists of three modules designed to teach users what bias is, how to recognize it, and how to minimize its impact
Time frame: 8 weeks
Acceptability will be assessed in all participants by the Acceptability of Intervention Measure (AIM)
Time frame: 8 weeks
Feasibility will be assessed in all participants by the Feasibility of Intervention Measure (FIM)
Time frame: 8 weeks
As a measure of feasibility, we will evaluate how many weeks are needed to recruit our desired study sample
Time frame: 8 weeks
As a measure of feasibility, we will measure the number strategy videos completed
Time frame: 8 weeks
As a measure of feasibility, we will measure how many participants complete their final follow-up visit
Time frame: 8 weeks
Impact of the intervention on reducing implicit bias among pharmacy interns will be assessed by the Race Implicit Association Test (IAT). In the IAT participants respond to items that are to be categorized into four groups: two representing racial groups (White vs. Black/Latinx) and two representing valences (negative vs. positive), which are presented in pairs. The concept is that when the social group and valence mapped onto the same response are strongly associated, individuals respond more quickly than when they are weakly associated. The IAT is graded using a D score ranging from -2.0 to 2.0 (the average D score αs =0.78). Scores between -0.15 and 0.15 are considered to represent no preference for Whites, 0.16 to 0.35 and 0.36 to 0.65 slight and moderate preference, and values greater than 0.65 in absolute value strong preference
Time frame: 8 weeks
Will be measured by using the Concern about Discrimination scale which is a 4-item questionnaire to measure participants' beliefs that discrimination is a problem in society. Responses to each item are rated on a scale of 1 (strongly disagree) to 10 (strongly agree). Responses are averaged with a high score indicating high concern and vice versa.
Contact information is provided by the study sponsor or research team.
Abubaker I Saeed
CONTACT
Jessica Haberer
CONTACT
Massachusetts General Hospital
Other
The Impact of an Intervention to Reduce Pharmacists' Racial Bias Towards People of Color at Risk of HIV
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