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NCT05867212 | Not yet recruiting | HIV Infections


Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.
Sponsor:

Kelley-Ross & Associates, Inc.

Information provided by (Responsible Party):

Elyse Tung

Brief Summary:

The goal of this demonstration project or observational study is to evaluate the feasibility and acceptability of a pharmacist-managed cabotegravir long acting injectable for PrEP program in a community pharmacy setting. The main question it aims to answer are: Is the program feasible and acceptable at the end of 1 year of operations? What are the facilitators and barriers of the program? Participants who want to start the FDA approved cabotegravir long acting injectable medication for PrEP will have the option participating in surveys and a review of their electronic health records. Medication will be administered based on FDA approved labeling guidelines and their PrEP care will be part of standard of care per CDC. Pharmacists who want to provide the service to their patients will have the option of participating in surveys pre and post implementation.

Condition or disease

HIV Infections

Intervention/treatment

Cabotegravir Injection [Apretude]

Study Type : Observational
Estimated Enrollment : 50 participants
Official Title : Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : November 30, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 18 years of age or older at the time of screening
  • Weight ≥ 35 kg
  • HIV-negative status
  • Willing to provide informed consent and undergo all required study procedures.
Exclusion Criteria
  • Unknown or positive HIV status
  • Coadministration of drugs that significantly decrease cabotegravir concentrations according to the FDA package insert.
  • Any participants that do not meet criteria for management under CDTA

Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.

Location Details


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Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Washington

Kelley-Ross Pharmacy at the Polyclinic

Seattle, Washington, United States, 98104

Not yet recruiting

United States, Washington

Kelley-Ross Capitol Hill Pharmacy

Seattle, Washington, United States, 98122

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