NCT06530225

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
49mo left

Started May 2026

Longer than P75 for all trials

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

July 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

July 27, 2024

Last Update Submit

December 2, 2025

Conditions

Keywords

PrEP, HIV Prevention

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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

Interventions

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.

Community Based Pharmacies

Eligibility Criteria

Age24 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Community pharmacists in Louisiana providing PrEP prescriptions.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xavier University of Louisiana

New Orleans, Louisiana, 70125, United States

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Sara Al-Dahir, PharmD, PhD

CONTACT

Ibrahim Hamed, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2024

First Posted

July 31, 2024

Study Start

May 1, 2026

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2030

Last Updated

December 4, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

De-identified, conglomerate data will be provided upon request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
5/1/25 - 4/30/30
More information

Locations