Clinical trial NCT06530225: Are Louisiana Pharmacists PrEPared? Implementing Training and an Active PrEP (Pre-Exposure Prophylaxis) Prescribing Surveillance Program
Official 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Prevention
Keywords: PrEP, HIV Prevention
Lead sponsor: Xavier University of Louisiana.
Sponsor class: OTHER
Collaborators: name: Louisiana Public Health Institute
First posted: 2024-07-31
Enrollment: 75
Sex: ALL
Minimum age (years): 24
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

Brief summary: 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

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.

Eligibility criteria: Inclusion Criteria:

* Community pharmacists in Louisiana providing PrEP prescriptions.

Exclusion Criteria:

* None

Primary outcomes:
measure: PrEP Prescribing
timeFrame: May 1, 2025- April 30, 2029
measure: Pharmacists' Knowledge and Confidence in PrEP prescribing
timeFrame: May 1, 2025- April 30, 2026
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Xavier University of Louisiana
state: Louisiana
Study officials:
References: