HIV InfectionsIDCaPPNCT05867212
Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.
An observational study of HIV Infections, run by Kelley-Ross & Associates, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cabotegravir Injection [Apretude]
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2023to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kelley-Ross Pharmacy at the Polyclinic
Seattle, Washington, 98104
Kelley-Ross Capitol Hill Pharmacy
Seattle, Washington, 98122
About this study
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:
Read more
- 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
- Being tested
- Cabotegravir Injection [Apretude]
- Keywords
- Cabotegravir, pharmacy, HIV PrEP, pre-exposure prophylaxis, long acting injection, Apretude
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants recruited in PrEP care
Percentage of participants recruited into PrEP care at initiation
Measured: initiation
Percentage of participants retained in PrEP care
Percentage of participants retained in PrEP care at the end of 1 year
Measured: 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
Measured: 1 year
Age
age in years at study initiation
Measured: initiation
Percentage Sex assigned at birth
Percentage of people who were assigned female at birth or assigned male at birth
Measured: 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.
Measured: 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.
Measured: 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.
Measured: initiation
Percentage of people with Insurance
Percentage of people with Medicaid, Medicare, commercial insurance, or uninsured throughout the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: initiation
Percentage of people who have inconsistent condom use during sex
Percentage of people who have inconsistent condom use during sex.
Measured: initiation
Percentage of people who use injection drugs
Percentage of people who use injection drugs
Measured: 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
Measured: 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
Measured: 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.
Measured: 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,
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months
Secondary outcomes (7)
Number of STI
number of chlamydia, syphilis, and gonorrhea infections detected during study
Measured: 1 year
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.
Measured: 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.
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start13 May 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelley-Ross & Associates, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elyse Tung, Kelley-Ross & Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867212
- Sponsor's protocol ID
- 001
- Acronym
- IDCaPP
- Status last verified
- Jul 2025
- First submitted
- 24 Apr 2023
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.
- ClinicalTrials.gov ID
- NCT05867212
- Acronym / sponsor ID
- IDCaPP / 001
- Conditions
- HIV Infections
- Keywords
- Cabotegravir, pharmacy, HIV PrEP, pre-exposure prophylaxis, long acting injection, Apretude
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kelley-Ross & Associates, Inc.University, hospital or other
- Study start
- 13 May 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | – |
Primary outcome
Percentage of participants recruited in PrEP care
Time frame: initiation
Percentage of participants recruited into PrEP care at initiation
Percentage of participants retained in PrEP care
Time frame: 1 year
Percentage of participants retained in PrEP care at the end of 1 year
Adherence rate
Time frame: 1 year
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
Age
Time frame: initiation
age in years at study initiation
Percentage Sex assigned at birth
Time frame: initiation
Percentage of people who were assigned female at birth or assigned male at birth
Percentage of people with Gender identity
Time frame: initiation
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.
Percentage of people in a certain race
Time frame: initiation
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.
Percentage of people who identify in a certain ethnicity
Time frame: initiation
Percentage of people who identify hispanic or latino, not hispanic or latino, prefer not to answer) ethnicity at initiation of study.
Percentage of people with Insurance
Time frame: 1 year
Percentage of people with Medicaid, Medicare, commercial insurance, or uninsured throughout the study.
Percentage of people who have housing
Time frame: 1 year
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.
Percentage of people who have a primary care provider
Time frame: initiation of study
Percentage of people who have a primary care provider relationship at initiation of study.
Percentage of people with more than 1 sexual partner
Time frame: initiation
Percentage of people with more than 1 sexual partner at initiation of study.
Percentage of people with HIV positive sexual partner
Time frame: initiation
Percentage of people who have one or more sexual partner who is HIV positive at initiation.
Percentage of people who have inconsistent condom use during sex
Time frame: initiation
Percentage of people who have inconsistent condom use during sex.
Percentage of people who use injection drugs
Time frame: initiation
Percentage of people who use injection drugs
Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months
Time frame: initiation
Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months at initiation
Percentage of people who have a history of sexually transmitted infection in the previous 6 months
Time frame: initiation
Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months at initiation
Percentage of people of certain background characteristics
Time frame: initiation
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.
Percentage of people with risk of acquiring HIV at initiation
Time frame: 1 year
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,
Percentage of people who are acceptable to cabotegravir long acting injectable for PrEP
Time frame: initiation
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.
Percentage of people feeling satisfied with cabotegravir long acting injectable for PrEP
Time frame: 1 year
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.
Percentage of people who discontinue long acting cabotegravir for PrEP for a particular reason
Time frame: discontinuation
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.
Percentage of Pharmacist providers who have certain attitudes to providing long acting cabotegravir for PrEP
Time frame: at initiation
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.
Percentage of pharmacist providers who are acceptable to providing long acting cabotegravir for PrEP
Time frame: 6 months
A 6 item questionnaire that explores the reasons a pharmacist is able to or not able to provide the service
7 secondary outcomes
Number of STI
Time frame: 1 year
Number of HIV seroconversions
Time frame: 1 year
Percentage of people who discontinue long acting cabotegravir for PrEP for a particular reason
Time frame: 1 year
Percentage of pharmacists who believe in certain barriers in providing the service
Time frame: 1 year
Percentage of pharmacists who believe in certain facilitators in providing the service
Time frame: 1 year
Percentage of patients who believe in certain facilitators for using the service
Time frame: 1 year
Percentage of patients who believe in certain barriers for using the service
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Kelley-Ross & Associates, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants recruited in PrEP care (time frame: initiation). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.