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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Prevention
• Intervention / Treatment: Other: Education and Mentoring for Prescribing Pharmacists

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Sara Al-Dahir, PharmD, PhD; Phone Number: 504-520-5766; Email: saaldah@xula.edu
• Study Contact Backup: Name: Ibrahim Hamed, BSc; Phone Number: 504-520-4537; Email: ihamed@xula.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70125
      • Xavier University of Louisiana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All practicing community pharmacists who are interested in a PrEP education course on equitable PrEP prescribing to address health disparities among the target patient population.

Description

Inclusion Criteria:

• Community pharmacists in Louisiana providing PrEP prescriptions.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Community Based Pharmacies; Community based pharmacies throughout Louisiana will be enrolled in a cohort of trained pharmacies for PrEP prescriptions for patients seeking HIV prevention medication.	Other: Education and Mentoring for Prescribing Pharmacists; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Prescribing	Number of PrEP prescriptions dispensed from pharmacy (Scale PrEP prescription/1,000 total prescriptions in 30 day period)	May 1, 2025- April 30, 2029
Pharmacists' Knowledge and Confidence in PrEP prescribing	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)	May 1, 2025- April 30, 2026

Collaborators and Investigators

• Sponsor: Xavier University of Louisiana.
• Collaborators: Louisiana Public Health Institute

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PrEP, HIV Prevention
• Additional Relevant MeSH Terms: Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: IRB1014-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified, conglomerate data will be provided upon request.
• IPD Sharing Time Frame: 5/1/25 - 4/30/30
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No