Clinical trial NCT06487351: Intervention to Reduce Implicit Bias in Pharmacies
Official title: The Impact of an Intervention to Reduce Pharmacists' Racial Bias Towards People of Color at Risk of HIV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bias, Implicit
HIV
Pre-exposure Prophylaxis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pharmacy intern participants will be randomized 1:1 using permuted block and stratified by gender and race/ethnicity to the adapted intervention or control group. Participants will be notified after consent.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

Eligibility criteria: Inclusion Criteria:

Three types of participants will be included

1. Pharmacy interns:

   * Pharmacy intern (non-licensed individual undergoing training and preparations for licensure examination).
   * Currently registered as a regular student in the School of Pharmacy, Bouvé College of Health Sciences at Northeastern University, Boston, MA.
   * Doing the internship in pharmacies located in cities with the highest average annual rate of HIV infection diagnosis in Suffolk County, MA.
   * Experience with PrEP (counsel PrEP candidates, complete PrEP continuing education activity, or awareness with current CDC guidelines on PrEP use) OR willingness to prescribe PrEP in the future (will be measured with one Yes/No question: "Are you willing to prescribe PrEP in the future?)
   * Moderate to high preference for White people as measured by the Implicit Association Test.
2. Pharmacy managers

   * Defined as an individual designated by a pharmacy owner to manage a pharmacy.
   * Pharmacy managers of pharmacies located in the same areas described above.
3. Pharmacy policymaker defined as official employee of the Boards of Registration in Pharmacy whose role is directly related to community pharmacy practice (e.g., director of pharmacy compliance).

Exclusion Criteria:

Inability to provide consent (e.g., intoxication), unwillingness to provide consent

Primary outcomes:
measure: Acceptability of the adapted intervention- Questionnaire
timeFrame: 8 weeks
measure: Feasibility of the adapted intervention- Questionnaire
timeFrame: 8 weeks
measure: Feasibility of the adapted intervention- Observed length of recruitment time
timeFrame: 8 weeks
measure: Feasibility of the adapted intervention- Self-reported video completion
timeFrame: 8 weeks
measure: Feasibility of the adapted intervention-Observed retention rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Reduction of implicit racial bias
timeFrame: 8 weeks
measure: Concern about discrimination
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
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