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

HIV Infections Clinical Trial

— IDCaPP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05867212
• Other study ID #: 001
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2023
• Source: Kelley-Ross & Associates, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Kelley-Ross Capitol Hill Pharmacy	Seattle	Washington
United States	Kelley-Ross Pharmacy at the Polyclinic	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kelley-Ross & Associates, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants recruited in PrEP care	Percentage of participants recruited into PrEP care at initiation	initiation
Primary	Percentage of participants retained in PrEP care	Percentage of participants retained in PrEP care at the end of 1 year	1 year
Primary	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
Primary	Age	age in years at study initiation	initiation
Primary	Percentage Sex assigned at birth	Percentage of people who were assigned female at birth or assigned male at birth	initiation
Primary	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
Primary	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
Primary	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
Primary	Percentage of people with Insurance	Percentage of people with Medicaid, Medicare, commercial insurance, or uninsured throughout the study.	1 year
Primary	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
Primary	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
Primary	Percentage of people with more than 1 sexual partner	Percentage of people with more than 1 sexual partner at initiation of study.	initiation
Primary	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
Primary	Percentage of people who have inconsistent condom use during sex	Percentage of people who have inconsistent condom use during sex.	initiation
Primary	Percentage of people who use injection drugs	Percentage of people who use injection drugs	initiation
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of STI	number of chlamydia, syphilis, and gonorrhea infections detected during study	1 year
Secondary	Number of HIV seroconversions	Number of HIV seroconversions detected during the study, reason for patient discontinuation, pharmacist provider and patient perspectives on barriers and facilitators.	1 year
Secondary	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.	1 year
Secondary	Percentage of pharmacists who believe in certain barriers in providing the service	A 6 item questionnaire that explores the reasons a pharmacist cannot provide the service	1 year
Secondary	Percentage of pharmacists who believe in certain facilitators in providing the service	A 6 item questionnaire that explores the reasons a pharmacist can provide the service	1 year
Secondary	Percentage of patients who believe in certain facilitators for using the service	A 7 item questionnaire will be given at every follow up appointment that explores the reason someone can use the service.	1 year
Secondary	Percentage of patients who believe in certain barriers for using the service	A 7 item questionnaire will be given at every follow up appointment that explores the reason someone cannot use the service.	1 year