NCT06487351

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jul 2027

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
3 years until next milestone

Study Start

First participant enrolled

July 1, 2027

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

June 27, 2024

Last Update Submit

November 8, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Acceptability of the adapted intervention- Questionnaire

    Acceptability will be assessed in all participants by the Acceptability of Intervention Measure (AIM)

    8 weeks

  • Feasibility of the adapted intervention- Questionnaire

    Feasibility will be assessed in all participants by the Feasibility of Intervention Measure (FIM)

    8 weeks

  • Feasibility of the adapted intervention- Observed length of recruitment time

    As a measure of feasibility, we will evaluate how many weeks are needed to recruit our desired study sample

    8 weeks

  • Feasibility of the adapted intervention- Self-reported video completion

    As a measure of feasibility, we will measure the number strategy videos completed

    8 weeks

  • Feasibility of the adapted intervention-Observed retention rate

    As a measure of feasibility, we will measure how many participants complete their final follow-up visit

    8 weeks

Secondary Outcomes (2)

  • Reduction of implicit racial bias

    8 weeks

  • Concern about discrimination

    8 weeks

Study Arms (2)

The adapted PHBI

EXPERIMENTAL

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.

Behavioral: The adapted PHBI

NIH Implicit Bias course

ACTIVE COMPARATOR

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.

Behavioral: The NIH Implicit Bias course

Interventions

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 adapted PHBI

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

NIH Implicit Bias course

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Three types of participants will be included
  • 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, BouvĂ© 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.
  • 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.
  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (15)

  • Devine PG, Forscher PS, Austin AJ, Cox WT. Long-term reduction in implicit race bias: A prejudice habit-breaking intervention. J Exp Soc Psychol. 2012 Nov;48(6):1267-1278. doi: 10.1016/j.jesp.2012.06.003.

    PMID: 23524616BACKGROUND
  • Woodward EN, Matthieu MM, Uchendu US, Rogal S, Kirchner JE. The health equity implementation framework: proposal and preliminary study of hepatitis C virus treatment. Implement Sci. 2019 Mar 12;14(1):26. doi: 10.1186/s13012-019-0861-y.

    PMID: 30866982BACKGROUND
  • Wingood GM, DiClemente RJ. The ADAPT-ITT model: a novel method of adapting evidence-based HIV Interventions. J Acquir Immune Defic Syndr. 2008 Mar 1;47 Suppl 1:S40-6. doi: 10.1097/QAI.0b013e3181605df1.

    PMID: 18301133BACKGROUND
  • Wingood GM, Dunkle K, Camp C, Patel S, Painter JE, Rubtsova A, DiClemente RJ. Racial differences and correlates of potential adoption of preexposure prophylaxis: results of a national survey. J Acquir Immune Defic Syndr. 2013 Jun 1;63 Suppl 1(0 1):S95-101. doi: 10.1097/QAI.0b013e3182920126.

    PMID: 23673895BACKGROUND
  • Crawford ND, Myers S, Young H, Klepser D, Tung E. The Role of Pharmacies in the HIV Prevention and Care Continuums: A Systematic Review. AIDS Behav. 2021 Jun;25(6):1819-1828. doi: 10.1007/s10461-020-03111-w. Epub 2021 Jan 2.

    PMID: 33386509BACKGROUND
  • McCree DH, Byrd KK, Johnston M, Gaines M, Weidle PJ. Roles for Pharmacists in the "Ending the HIV Epidemic: A Plan for America" Initiative. Public Health Rep. 2020 Sep/Oct;135(5):547-554. doi: 10.1177/0033354920941184. Epub 2020 Aug 11.

    PMID: 32780671BACKGROUND
  • Tung EL, Thomas A, Eichner A, Shalit P. Implementation of a community pharmacy-based pre-exposure prophylaxis service: a novel model for pre-exposure prophylaxis care. Sex Health. 2018 Nov;15(6):556-561. doi: 10.1071/SH18084.

    PMID: 30401342BACKGROUND
  • Hall WJ, Chapman MV, Lee KM, Merino YM, Thomas TW, Payne BK, Eng E, Day SH, Coyne-Beasley T. Implicit Racial/Ethnic Bias Among Health Care Professionals and Its Influence on Health Care Outcomes: A Systematic Review. Am J Public Health. 2015 Dec;105(12):e60-76. doi: 10.2105/AJPH.2015.302903. Epub 2015 Oct 15.

    PMID: 26469668BACKGROUND
  • Avant ND, Weed E, Connelly C, Hincapie AL, Penm J. Qualitative Analysis of Student Pharmacists' Reflections of Harvard's Race Implicit Association Test. Curr Pharm Teach Learn. 2018 May;10(5):611-617. doi: 10.1016/j.cptl.2018.02.002. Epub 2018 Mar 13.

    PMID: 29986821BACKGROUND
  • Cox WTL. Developing scientifically validated bias and diversity trainings that work: empowering agents of change to reduce bias, create inclusion, and promote equity. Manag Decis. 2023 Apr 17;61(4):1038-1061. doi: 10.1108/md-06-2021-0839. Epub 2022 Sep 5.

    PMID: 37090785BACKGROUND
  • Forscher PS, Lai CK, Axt JR, Ebersole CR, Herman M, Devine PG, Nosek BA. A meta-analysis of procedures to change implicit measures. J Pers Soc Psychol. 2019 Sep;117(3):522-559. doi: 10.1037/pspa0000160. Epub 2019 Jun 13.

    PMID: 31192631BACKGROUND
  • Lateef F. Simulation-based learning: Just like the real thing. J Emerg Trauma Shock. 2010 Oct;3(4):348-52. doi: 10.4103/0974-2700.70743.

    PMID: 21063557BACKGROUND
  • Zhao A, Dangerfield DT 2nd, Nunn A, Patel R, Farley JE, Ugoji CC, Dean LT. Pharmacy-Based Interventions to Increase Use of HIV Pre-exposure Prophylaxis in the United States: A Scoping Review. AIDS Behav. 2022 May;26(5):1377-1392. doi: 10.1007/s10461-021-03494-4. Epub 2021 Oct 20.

    PMID: 34669062BACKGROUND
  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PMID: 28851459BACKGROUND
  • Greenwald AG, McGhee DE, Schwartz JL. Measuring individual differences in implicit cognition: the implicit association test. J Pers Soc Psychol. 1998 Jun;74(6):1464-80. doi: 10.1037//0022-3514.74.6.1464.

    PMID: 9654756BACKGROUND

MeSH Terms

Conditions

Bias, Implicit

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehavior

Central Study Contacts

Jessica Haberer

CONTACT

Abubaker I Saeed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open label
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations