An observational study in HIV Infections, sponsored by Kelley-Ross & Associates, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Kelley-Ross & Associates, Inc. · Observational
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:
Pharmacists who want to provide the service to their patients will have the option of participating in surveys pre and post implementation.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 50 is below the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Kelley-Ross & Associates, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
50 subjects who meet all the inclusion criteria, none of the exclusion criteria, and provide informed consent will be enrolled as study participants
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.
Percentage of participants recruited in PrEP care
Percentage of participants recruited into PrEP care at initiation
Time frame: initiation
Percentage of participants retained in PrEP care
Percentage of participants retained in PrEP care at the end of 1 year
Time frame: 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
Time frame: 1 year
Age
age in years at study initiation
Time frame: initiation
Percentage Sex assigned at birth
Percentage of people who were assigned female at birth or assigned male at birth
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: initiation
Percentage of people with Insurance
Percentage of people with Medicaid, Medicare, commercial insurance, or uninsured throughout the study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: initiation
Percentage of people who have inconsistent condom use during sex
Percentage of people who have inconsistent condom use during sex.
Time frame: initiation
Percentage of people who use injection drugs
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
Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months at initiation
Time frame: 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
Time frame: 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.
Time frame: 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,
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 6 months
Number of STI
number of chlamydia, syphilis, and gonorrhea infections detected during study
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Kelley-Ross & Associates, Inc.