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NCT Number: NCT06530225

Are Louisiana Pharmacists PrEPared? Implementing Training and an Active PrEP (Pre-Exposure Prophylaxis) Prescribing Surveillance Program

Though broadening PrEP (Pre-Exposure Prophylaxis) availability to Louisiana pharmacies addresses key access issues for Louisiana's population, there is no current baseline data which explore current pharmacist and pharmacies' capacity to effectively provide PrEP therapy to patients who meet PrEP prescribing criteria. This study aims to explore1) Louisiana pharmacist and pharmacy capacity to provide PrEP under a state-based collaborative practice agreement, 2) a validated pharmacist education system addressing health disparities in PrEP prescribing and 3) the impact of state pharmacy based policies on equitable PrEP prescribing. Our central hypothesis is pharmacist trained in PrEP prescribing focusing on health disparities and implicit bias education and working with mentors in an implementation framework will have an increase in equitable PrEP prescribing

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Key information

Conditions

HIV Prevention

Age range

24 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xavier University of Louisiana

New Orleans, Louisiana, 70125, United States

About this study

The objective of this application is to create a statewide cohort of dispensing community-based pharmacists that are specifically trained to address health disparities in PrEP (Pre-Exposure Prophylaxis) prescribing. The specific aims of this application are:

Aim #1: Complete a rapid pharmacy landscape assessment on PrEP prescribing and maintenance from community pharmacies across Louisiana to measure frequency of PrEP seeking, prescribing and follow-up of PrEP initiation Hypothesis 1a: Pharmacists in rural parishes (counties) will have lower overall PrEP prescribing rates compared to their urban and suburban counterparts.

Hypothesis 1b: PrEP utilization patterns by African Americans, Hispanics and Women of all races will have a decreased lack of utilization PrEP compared to their white, male counterparts.

Aim #2: Measure the impact of a validated pharmacist PrEP training program on pharmacist competence and capacity in PrEP prescribing for CDC recognized target populations. The focus of the education will be addressing health disparities and implicit bias in PrEP prescribing.

Hypothesis 2:Pharmacists who complete the implicit bias and cultural competence training will report a 20% increase in baseline confidence and competence in PrEP prescribing for target vulnerable communities.

Aim #3: Measure the impact of an implementation science community-pharmacy based intervention on addressing PrEP prescribing among women, African-Americans and Hispanics. The impact of the program will implement a state-based PrEP surveillance program housed in the College of Pharmacy comparing PrEP prescribing patterns among trained pharmacists vs clinic based prescribing (control) as provided by the consortium of health network data housed at the Louisiana Public Health Institute.

Hypothesis 3a: Trained pharmacists will have a 15% increase in pharmacy PrEP dispensing from baseline vs non-trained pharmacists in the research network.

Hypothesis 3b: Pharmacy PrEP prescribing among trained pharmacists will represent a 20% increase in minority based prescribing, specifically African-American, compared to current health network clinic prescribing patterns.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Community pharmacists in Louisiana providing PrEP prescriptions.

Exclusion criteria

  • None

Treatment and study plan

Education and Mentoring for Prescribing Pharmacists

Other

Pharmacists enrolled in the PrEP prescribing cohort will receive implicit bias, health disparity and health equity training for HIV prevention. In addition, the pharmacists will receive mentorship and receive an implementation toolkit on best practices for PrEP prescribing.

Primary outcomes

  1. PrEP Prescribing

    Time frame: May 1, 2025- April 30, 2029

    Number of PrEP prescriptions dispensed from pharmacy (Scale PrEP prescription/1,000 total prescriptions in 30 day period)

  2. Pharmacists' Knowledge and Confidence in PrEP prescribing

    Time frame: May 1, 2025- April 30, 2026

    Pharmacists will complete a pre and post-test on knowledge and confidence in PrEP prescribing to target populations. Knowledge will be scored on a graded scale of 0 (lowest to 100 (highest). Confidence will be scored on a Likert Scale (1 - least confident, 5 most confident)

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Hamed, BSc

CONTACT

[email protected]

504-520-4537

Sara Al-Dahir, PharmD, PhD

CONTACT

[email protected]

504-520-5766

Sponsors and collaborators

Lead sponsor

Xavier University of Louisiana.

Other

Collaborators

  • Louisiana Public Health Institute

Registry information

Official study title

Are Louisiana Pharmacists PrEPared? Implementing Training and an Active PrEP (Pre-Exposure Prophylaxis) Prescribing Surveillance Program to Achieve Equity in Pharmacy Based PrEP Prescribing in Louisiana

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 31, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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