Clinical trial NCT05867212: Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.
Official title: Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Infections
Keywords: Cabotegravir
pharmacy
HIV PrEP
pre-exposure prophylaxis
long acting injection
Apretude
Lead sponsor: Kelley-Ross & Associates, Inc.
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 subjects who meet all the inclusion criteria, none of the exclusion criteria, and provide informed consent will be enrolled as study participants

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.


Eligibility 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

Primary outcomes:
measure: Percentage of participants recruited in PrEP care
timeFrame: initiation
measure: Percentage of participants retained in PrEP care
timeFrame: 1 year
measure: Adherence rate
timeFrame: 1 year
measure: Age
timeFrame: initiation
measure: Percentage Sex assigned at birth
timeFrame: initiation
measure: Percentage of people with Gender identity
timeFrame: initiation
measure: Percentage of people in a certain race
timeFrame: initiation
measure: Percentage of people who identify in a certain ethnicity
timeFrame: initiation
measure: Percentage of people with Insurance
timeFrame: 1 year
measure: Percentage of people who have housing
timeFrame: 1 year
measure: Percentage of people who have a primary care provider
timeFrame: initiation of study
measure: Percentage of people with more than 1 sexual partner
timeFrame: initiation
measure: Percentage of people with HIV positive sexual partner
timeFrame: initiation
measure: Percentage of people who have inconsistent condom use during sex
timeFrame: initiation
measure: Percentage of people who use injection drugs
timeFrame: initiation
measure: Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months
timeFrame: initiation
measure: Percentage of people who have a history of sexually transmitted infection in the previous 6 months
timeFrame: initiation
measure: Percentage of people of certain background characteristics
timeFrame: initiation
measure: Percentage of people with risk of acquiring HIV at initiation
timeFrame: 1 year
measure: Percentage of people who are acceptable to cabotegravir long acting injectable for PrEP
timeFrame: initiation
measure: Percentage of people feeling satisfied with cabotegravir long acting injectable for PrEP
timeFrame: 1 year
measure: Percentage of people who discontinue long acting cabotegravir for PrEP for a particular reason
timeFrame: discontinuation
measure: Percentage of Pharmacist providers who have certain attitudes to providing long acting cabotegravir for PrEP
timeFrame: at initiation
measure: Percentage of pharmacist providers who are acceptable to providing long acting cabotegravir for PrEP
timeFrame: 6 months
Secondary outcomes:
measure: Number of STI
timeFrame: 1 year
measure: Number of HIV seroconversions
timeFrame: 1 year
measure: Percentage of people who discontinue long acting cabotegravir for PrEP for a particular reason
timeFrame: 1 year
measure: Percentage of pharmacists who believe in certain barriers in providing the service
timeFrame: 1 year
measure: Percentage of pharmacists who believe in certain facilitators in providing the service
timeFrame: 1 year
measure: Percentage of patients who believe in certain facilitators for using the service
timeFrame: 1 year
measure: Percentage of patients who believe in certain barriers for using the service
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kelley-Ross Pharmacy at the Polyclinic
state: Washington
city: Seattle
country: United States
facility: Kelley-Ross Capitol Hill Pharmacy
state: Washington
Study officials:
References: