HIV PreventionNCT06530225
Are Louisiana Pharmacists PrEPared? Implementing Training and an Active PrEP (Pre-Exposure Prophylaxis) Prescribing Surveillance Program
An observational study of HIV Prevention, run by Xavier University of Louisiana. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 99 years
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Education and Mentoring for Prescribing Pharmacists
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 99 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Community pharmacists in Louisiana providing PrEP prescriptions.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Xavier University of Louisiana
New Orleans, Louisiana, 70125
About this study
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
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
Read the 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.
- Conditions
- HIV Prevention
- Being tested
- Education and Mentoring for Prescribing Pharmacists
- Keywords
- PrEP, HIV Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Mentoring for Prescribing PharmacistsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Education and Mentoring for Prescribing Pharmacists |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Prescribing
Number of PrEP prescriptions dispensed from pharmacy (Scale PrEP prescription/1,000 total prescriptions in 30 day period)
Measured: 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)
Measured: May 1, 2025- April 30, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jan 2027 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xavier University of Louisiana.
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana Public Health Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530225
- Sponsor's protocol ID
- IRB1014-25
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, conglomerate data will be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06530225
- Acronym / sponsor ID
- IRB1014-25
- Conditions
- HIV Prevention
- Keywords
- PrEP, HIV Prevention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Xavier University of Louisiana.University, hospital or other
- Collaborators
- Louisiana Public Health Institute
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community Based Pharmacies | – | Other: Education and Mentoring for Prescribing PharmacistsCommunity based pharmacies throughout Louisiana will be enrolled in a cohort of trained pharmacies for PrEP prescriptions for patients seeking HIV prevention medication. |
Who may qualify
- Ages
- 24 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Community pharmacists in Louisiana providing PrEP prescriptions.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and Mentoring for Prescribing PharmacistsPharmacists 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. | Other | Community Based Pharmacies |
Primary outcome
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified, conglomerate data will be provided upon request.
Related trials for HIV Prevention
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe
HIV (Human Immunodeficiency Virus), HPV
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Prevention, run by Xavier University of Louisiana. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Al-Dahir, PharmD, PhD (504-520-5766, saaldah@xula.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Prescribing (time frame: May 1, 2025- April 30, 2029). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.