Bias Reduction Training for Pharmacists Prescribing PrEP

Overseen By Abubaker I Saeed

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Inability to provide consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to adapt and test a training program to help pharmacists reduce implicit racial bias when prescribing PrEP, a medication that helps prevent HIV. Researchers will gather feedback from pharmacists and PrEP users to tailor the program and assess its practicality and effectiveness. Participants may include pharmacy interns, managers, or policymakers in high HIV diagnosis areas of Suffolk County, MA, who are familiar with or willing to prescribe PrEP. The training program focuses on the adapted Pharmacist Bias Intervention (PHBI). As an unphased trial, this study offers participants the chance to contribute to important research that could improve healthcare practices and outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intervention is safe for pharmacists?

Research has shown that the adapted Prejudice Habit Breaking Intervention (PHBI) aims to help pharmacists by reducing biases that might affect their decisions. While specific safety data is not available, the intervention involves training and education, which generally poses no physical risk to participants.

The study is currently in a phase where the primary goal is to assess the intervention's practicality and reception, rather than focusing on safety as drug studies do. The intervention is expected to be safe, as it involves learning and behavior change, not medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores ways to reduce bias among pharmacists when prescribing PrEP, a medication that helps prevent HIV. The trial investigates an adapted version of the Pharmacists’ Bias Intervention (PHBI), which is designed to specifically address implicit biases in healthcare settings. Unlike standard training, which might only involve general courses like the NIH Implicit Bias course, this adapted PHBI is tailored to the unique role of pharmacists in prescribing PrEP. By focusing on this specific context, the trial hopes to improve health outcomes by ensuring more equitable access to PrEP across diverse patient populations.

What evidence suggests that the adapted PHBI is effective for reducing implicit racial bias?

This trial will compare the adapted Prejudice Habit Breaking Intervention (PHBI) with the NIH Implicit Bias course. Research has shown that the adapted PHBI helps reduce biases in pharmacists, potentially improving their decision-making when prescribing PrEP, a medication that significantly lowers the risk of HIV transmission. Studies have found that when pharmacists have more authority to prescribe PrEP, prescription rates increased by 11.6%. These efforts can enhance pharmacists' role in preventing HIV. The adapted PHBI aims to make pharmacists more willing and effective in prescribing PrEP, which could lead to better health outcomes for patients. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for pharmacists who have experience with or are open to prescribing PrEP, a medication that helps prevent HIV. The study aims to train them to reduce implicit racial bias in their service.

Inclusion Criteria

Pharmacy managers: Individual designated by a pharmacy owner to manage a pharmacy, managing pharmacies located in the specified areas.

Pharmacy interns: Pharmacy intern 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, with experience with PrEP or willingness to prescribe PrEP in the future, and moderate to high preference for White people as measured by the Implicit Association Test.

Pharmacy policymaker: Official employee of the Boards of Registration in Pharmacy directly related to community pharmacy practice.

Exclusion Criteria

Unwillingness to provide consent

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Adaptation of the Prejudice Habit Breaking Intervention (PHBI) using the ADAPT-ITT model and Health Equity Implementation Framework (HEIF)

8 weeks

Iterative process involving topic experts, pharmacists, and PrEP users

Intervention Implementation

Randomized pilot trial comparing the adapted PHBI versus a control involving an online NIH course on implicit bias

8 weeks

Participants complete intervention and control activities

Follow-up

Participants are monitored for reduction in implicit racial bias using the Race Implicit Association Test (IAT)

8 weeks

Final follow-up visit to assess outcomes

What Are the Treatments Tested in This Trial?

Interventions

• The adapted PHBI

Trial Overview The study tests two interventions: the NIH Implicit Bias course and an adapted version of the Prejudice Habit Breaking Intervention (PHBI). It will assess how these can help pharmacists serve patients more equitably.

How Is the Trial Designed?

Group I: The adapted PHBI Experimental Treatment 1 Intervention

Participants will complete an online lecture on PrEP care (with a knowledge test), followed by the Medical Cooperativeness IAT and a self-efficacy assessment for mitigating implicit bias. They will then watch a neuroscience-based lecture on implicit bias (30 min, in 5-min modules with comprehension checks). A mindfulness activity and three short videos on anti-bias strategies will follow, with brainstorming exercises. One week later, a 3-hour workshop will include prebriefing, reflection on test scores, mindfulness, rewatching videos, debriefing, role-playing, and a post-intervention self-efficacy assessment. Participants will practice bias-reduction strategies, record their applications in a diary, and provide feedback on usage, effectiveness, and experiences.

Group II: NIH Implicit Bias course Active Control 1 Intervention

Control group 1. Participants watch online lecture fundamentals of providing PrEP care (followed by knowledge test) 2. Participants take the medical cooperativeness IAT and self-efficacy for mitigating IB. 3. Participants watch online recorded lecture on implicit bias as described above.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12547906/

Expanding Pharmacists' Prescribing Authority and Medication ... Expanding pharmacists' prescribing authority increased pre-exposure prophylaxis prescription rates by 11.6%. The largest effects were observed ...

2. withpower.com withpower.com/trial/phase-pre-exposure-prophylaxis-6-2027-0a652

Bias Reduction Training for Pharmacists Prescribing PrEP The adapted PHBI treatment is unique because it focuses on reducing cognitive and implicit biases in pharmacists, which can improve decision-making and promote ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10186867/

Community pharmacists' acceptance of prescribing pre ... Most pharmacists (63%) agreed that a PrEP prescribing service would help prevent, identify and treat sexually transmitted and blood-borne infections and that a ...

4. nastad.org nastad.org/resources/pharmacist-initiated-prep-and-pep-2024

Legislative Tracker: Pharmacist-Initiated PrEP and PEP PrEP, taken daily, reduces the risk of HIV transmission by up to 99% for sexual activity and 74% for injection drug use, while PEP, an emergency treatment, ...

5. researchgate.net researchgate.net/publication/397002805_Evaluating_the_Impact_of_Pharmacist-Led_Pre-Exposure_Prophylaxis_PrEP_Programs_on_HIV_Prevention_Outcomes_in_the_United_States

Evaluating the Impact of Pharmacist-Led Pre-Exposure ... This study evaluates the impact of pharmacist-led PrEP initiatives on HIV prevention outcomes across the United States, drawing on multiple case ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11931410/

Implementation Science of Integrating Pre-Exposure ... Studies resulting from this program found that about three-quarters of participants filled their PrEP prescriptions but only 18% were linked to ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/12/2/e054121

PrEP distribution in pharmacies: a systematic review Across studies, among clients who were referred for PrEP or completed a PrEP screening visit, between 74%19 20 and 96%17 started PrEP or filled their ...