Cabotegravir Injection [Apretude]
DrugPeople 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.
NCT Number: NCT05867212
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Kelley-Ross Capitol Hill Pharmacy, Seattle, Washington, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: initiation
Percentage of participants recruited into PrEP care at initiation
Time frame: 1 year
Percentage of participants retained in PrEP care at the end of 1 year
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
Time frame: initiation
age in years at study initiation
Time frame: initiation
Percentage of people who were assigned female at birth or assigned male at birth
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.
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.
Time frame: initiation
Percentage of people who identify hispanic or latino, not hispanic or latino, prefer not to answer) ethnicity at initiation of study.
Time frame: 1 year
Percentage of people with Medicaid, Medicare, commercial insurance, or uninsured throughout the study.
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.
Time frame: initiation of study
Percentage of people who have a primary care provider relationship at initiation of study.
Time frame: initiation
Percentage of people with more than 1 sexual partner at initiation of study.
Time frame: initiation
Percentage of people who have one or more sexual partner who is HIV positive at initiation.
Time frame: initiation
Percentage of people who have inconsistent condom use during sex.
Time frame: initiation
Percentage of people who use injection drugs
Time frame: initiation
Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months at initiation
Time frame: initiation
Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months at initiation
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.
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,
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.
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.
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.
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.
Time frame: 6 months
A 6 item questionnaire that explores the reasons a pharmacist is able to or not able to provide the service
Time frame: 1 year
number of chlamydia, syphilis, and gonorrhea infections detected during study
Time frame: 1 year
Number of HIV seroconversions detected during the study, reason for patient discontinuation, pharmacist provider and patient perspectives on barriers and facilitators.
Time frame: 1 year
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.
Time frame: 1 year
A 6 item questionnaire that explores the reasons a pharmacist cannot provide the service
Time frame: 1 year
A 6 item questionnaire that explores the reasons a pharmacist can provide the service
Time frame: 1 year
A 7 item questionnaire will be given at every follow up appointment that explores the reason someone can use the service.
Time frame: 1 year
A 7 item questionnaire will be given at every follow up appointment that explores the reason someone cannot use the service.
Kelley-Ross & Associates, Inc.
Other
Acronym: IDCaPP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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