Pharmacies in HIV Prevention: Fellowship, Fundamentals, and Sustainable Finances

September 14, 2026 updated by: Joanne Stekler, MD MPH, University of Washington
Quantify the impact of an online Virtual Community of Practice (VCoP) to increase pharmacist knowledge and accelerate provision of pre-exposure prophylaxis (PrEP) for HIV prevention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Communities of practice unite individuals and provide opportunity to share knowledge, develop skills, and reduce isolation. We will conduct a Type 3 hybrid effectiveness-implementation trial to evaluate implementation outcomes (e.g. acceptability, feasibility, and adoption) and effectiveness (e.g. number of PrEP initiations). The primary outcome will compare time to first PrEP prescription among 180 pharmacies randomized to an enhanced standard of care arm plus or minus VCoP access. We hypothesize that pharmacies with VCoP access will create their programs and provide their first oral PrEP prescriptions in less time than pharmacies without VCoP access.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lisa Niemann
  • Phone Number: 206-744-8887
  • Email: niemal@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pharmacists or pharmacy staff working at pharmacy in U.S.
  • Pharmacy is not currently providing PrEP

Exclusion Criteria:

Any potential participants unable to fully complete the proposed study activities due to health or other concerns will be excluded in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enhanced Standard of Care
This arm will be sent a syllabus introducing them to the six-month business and program plan. Assignments will be delivered every other week, focusing on clinical, epidemiological, and business related educational tasks to be completed to prepare pharmacist to offer PrEP. The study team will be available for email assistance.
Behavioral: Enhanced Standard of Care
A self-guided business and program planning. This arm will be sent a syllabus introducing them to the six-month business and program plan. Assignments will be delivered every other week, focusing on clinical, epidemiological, and business related educational tasks to be completed to prepare pharmacist to offer PrEP. The study team will be available for email assistance.
Experimental: Virtual Community of Practice Arm
VCoP arm participants will have the same assignments as described in the enhanced SoC arm. Additionally, pharmacists and staff randomized to gain VCoP access will be invited by the research coordinator to the VCoP. The VCoP will include the research team and pharmacists with experience in PrEP provision to provide education and peer support.
Behavioral: Virtual Community of Practice

Healthcare communities of practice (CoPs) are becoming increasingly popular. CoPs unite individuals with common interests and provide opportunity to collaboratively learn and develop skills to improve professional practice, and reduce isolation. CoPs can play a role when educational needs cannot be satisfied by traditional methods. With advances in technology and the COVID-19 pandemic, virtual communities of practice (VCoPs) have spread across the globe.

One of the primary benefits of online VCoPs is expanded potential for professional development and remote networking. VCoP members can use asynchronous communication to develop relationships and learn from peers who have experience with laws, policies, insurance companies and other healthcare institutions across the U.S. This education and peer support provided by VCoPs could be particularly beneficial for pharmacists in rural areas or in EHE jurisdictions without access to similar resources as academic or urban pharmacists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first PrEP prescription
Time Frame: for 2 years from participant enrollment.
Time to first PrEP prescription by participating pharmacists as self-reported.
for 2 years from participant enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Clinics Started
Time Frame: within 2 years of participant enrollment
Total number of PrEP Clinics started by participants
within 2 years of participant enrollment
Total numbers of PrEP prescriptions initiated
Time Frame: within 2 years of participant enrollment
Total numbers of PrEP prescriptions initiated by participants
within 2 years of participant enrollment
characteristics of PrEP patients
Time Frame: 2 years post-enrollment
characteristics of PrEP patients
2 years post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Joanne Stekler, MD, MPH, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

February 28, 2031

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00023020
  • 1R01MH140473 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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