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

NCT05867212 | Completed FDA Drug

• 1 other identifier: 001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

Cabotegravir; pharmacy; HIV PrEP; pre-exposure prophylaxis; long acting injection; Apretude

Outcome Measures

Primary Outcomes (24)

• Percentage of participants recruited in PrEP care

  Percentage of participants recruited into PrEP care at initiation

  initiation

• Percentage of participants retained in PrEP care

  Percentage of participants retained in PrEP care at the end of 1 year

  1 year

• Adherence rate

  Number of participants who adhered to target injection windows period by completing injection appointments versus the number of participants who missed their target injection window period by not completing injection appointments

  1 year

• Age

  age in years at study initiation

  initiation

• Percentage Sex assigned at birth

  Percentage of people who were assigned female at birth or assigned male at birth

  initiation

• Percentage of people with Gender identity

  Percentage of people with gender identity of male, female, trans male, trans female, genderqueer or gender nonconforming, different identity, prefer not to answer at initiation of study.

  initiation

• Percentage of people in a certain race

  Percentage of people who identify as American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White, other, or prefer not to answer) race at initiation of study.

  initiation

• Percentage of people who identify in a certain ethnicity

  Percentage of people who identify hispanic or latino, not hispanic or latino, prefer not to answer) ethnicity at initiation of study.

  initiation

• Percentage of people with Insurance

  Percentage of people with Medicaid, Medicare, commercial insurance, or uninsured throughout the study.

  1 year

• Percentage of people who have housing

  Percentage of people who have a steady place to live, a place to live today but worried about losing it in the future, or do not have a steady place to live at initiation of study.

  1 year

• Percentage of people who have a primary care provider

  Percentage of people who have a primary care provider relationship at initiation of study.

  initiation of study

• Percentage of people with more than 1 sexual partner

  Percentage of people with more than 1 sexual partner at initiation of study.

  initiation

• Percentage of people with HIV positive sexual partner

  Percentage of people who have one or more sexual partner who is HIV positive at initiation.

  initiation

• Percentage of people who have inconsistent condom use during sex

  Percentage of people who have inconsistent condom use during sex.

  initiation

• Percentage of people who use injection drugs

  Percentage of people who use injection drugs

  initiation

• Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months

  Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months at initiation

  initiation

• Percentage of people who have a history of sexually transmitted infection in the previous 6 months

  Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months at initiation

  initiation

• Percentage of people of certain background characteristics

  A baseline questionnaire will be used at initiation to collect background characteristics to determine percentage of people of a race, ethnicity, gender identity, sex assigned at birth, marital status, education level, employment status, annual income, and living situation.

  initiation

• Percentage of people with risk of acquiring HIV at initiation

  A baseline questionnaire will be used at initiation to collection information on percentage of people who engage in sex, has sex with and partner who is living with HIV, has sex without a condom, been diagnosed with an STI in the last 6 months, have used HIV post-exposure prophylaxis in the lat 12 months,

  1 year

• Percentage of people who are acceptable to cabotegravir long acting injectable for PrEP

  A 27 item questionnaire that will be given at baseline that explores the reason a person would like to be on an injection for PrEP, reasons for not being able to make injection appointments, and rating their feelings around judgement for being on an injection.

  initiation

• Percentage of people feeling satisfied with cabotegravir long acting injectable for PrEP

  A 7 item questionnaire will be given at every follow up appointment that explores the reason someone wants to stay on an injectable for PrEP, how comfortable they feel being on the injection, reasons for not being able to make injection appointments, and rating their feelings around judgement for being on an injection.

  1 year

• Percentage of people who discontinue long acting cabotegravir for PrEP for a particular reason

  A 2 item questionnaire will be given a discontinuation that explores why a person discontinues long acting cabotegravir and what their HIV prevention strategy will be moving forward.

  discontinuation

• Percentage of Pharmacist providers who have certain attitudes to providing long acting cabotegravir for PrEP

  A 5 point questionnaire that explores a pharmacists reasons for providing long acting injectable cabotegravir for PrEP, reasons for being able to or not being able to provide the service.

  at initiation

• Percentage of pharmacist providers who are acceptable to providing long acting cabotegravir for PrEP

  A 6 item questionnaire that explores the reasons a pharmacist is able to or not able to provide the service

  6 months

Secondary Outcomes (7)

• Number of STI

  1 year

• Number of HIV seroconversions

  1 year

• Percentage of people who discontinue long acting cabotegravir for PrEP for a particular reason

  1 year

• Percentage of pharmacists who believe in certain barriers in providing the service

  1 year

• Percentage of pharmacists who believe in certain facilitators in providing the service

  1 year

Interventions

Cabotegravir Injection [Apretude] DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kelley-Ross & Associates, Inc.: lead

Study Sites (2)

Kelley-Ross Pharmacy at the Polyclinic

Seattle, Washington, 98104, United States

Location

Kelley-Ross Capitol Hill Pharmacy

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Services

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 19, 2023
• Study Start: May 13, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)