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

NCT ID: NCT05867212

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-13

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Cabotegravir Injection [Apretude]

People who want to get the long acting injectable will have the option in participating in surveys after their visit and have their electronic health records reviewed.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kelley-Ross & Associates, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Elyse Tung

Director of Clinical Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kelley-Ross Pharmacy at the Polyclinic

Seattle, Washington, United States

Site Status

Kelley-Ross Capitol Hill Pharmacy

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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