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Набор скоро начнётся NCT06487351

Intervention to Reduce Implicit Bias in Pharmacies

Без фазы С лечением Bias, Implicit HIV Pre-exposure Prophylaxis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The adapted PHBI, The NIH Implicit Bias course.
Кому может быть актуально
Состояния в реестре: Bias, Implicit, HIV, Pre-exposure Prophylaxis. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Impact of an Intervention to Reduce Pharmacists' Racial Bias Towards People of Color at Risk of HIV

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое The adapted PHBI
    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.
  • Поведенческое The NIH Implicit Bias course
    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

Первичные конечные точки

  • Acceptability of the adapted intervention- Questionnaire [Срок оценки: 8 weeks]
  • Feasibility of the adapted intervention- Questionnaire [Срок оценки: 8 weeks]
  • Feasibility of the adapted intervention- Observed length of recruitment time [Срок оценки: 8 weeks]
  • Feasibility of the adapted intervention- Self-reported video completion [Срок оценки: 8 weeks]
  • Feasibility of the adapted intervention-Observed retention rate [Срок оценки: 8 weeks]
Вторичные конечные точки (2)
  • Reduction of implicit racial bias [Срок оценки: 8 weeks]
  • Concern about discrimination [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

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, 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.
  • 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).

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Boston

Публикации

  • 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 23524616
  • 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 30866982
  • 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 18301133
  • 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 23673895
  • 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 33386509
  • 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 32780671
  • 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 30401342
  • 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 26469668

Идентификаторы

NCT: NCT06487351 · 2024P001326

Первоисточники (государственные реестры)

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