Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percentage of participants recruited in PrEP care
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Percentage of participants recruited in PrEP care
时间窗: initiation
Percentage of participants recruited into PrEP care at initiation
Percentage of people with more than 1 sexual partner
时间窗: initiation
Percentage of people with more than 1 sexual partner at initiation of study.
Percentage of people of certain background characteristics
时间窗: 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
时间窗: 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 participants retained in PrEP care
时间窗: 1 year
Percentage of participants retained in PrEP care at the end of 1 year
Percentage Sex assigned at birth
时间窗: initiation
Percentage of people who were assigned female at birth or assigned male at birth
Percentage of people in a certain race
时间窗: 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
时间窗: 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
时间窗: 1 year
Percentage of people with Medicaid, Medicare, commercial insurance, or uninsured throughout the study.
Percentage of people who have a primary care provider
时间窗: initiation of study
Percentage of people who have a primary care provider relationship at initiation of study.
Percentage of people who are acceptable to cabotegravir long acting injectable for PrEP
时间窗: 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.
Adherence rate
时间窗: 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
Percentage of people with Gender identity
时间窗: 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 with HIV positive sexual partner
时间窗: initiation
Percentage of people who have one or more sexual partner who is HIV positive at initiation.
Age
时间窗: initiation
age in years at study initiation
Percentage of people who have housing
时间窗: 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 use injection drugs
时间窗: initiation
Percentage of people who use injection drugs
Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months
时间窗: initiation
Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months at initiation
Percentage of people who have inconsistent condom use during sex
时间窗: initiation
Percentage of people who have inconsistent condom use during sex.
Percentage of people who have a history of sexually transmitted infection in the previous 6 months
时间窗: initiation
Percentage of people who use HIV post exposure prophylaxis (PEP) in the last 12 months at initiation
Percentage of pharmacist providers who are acceptable to providing long acting cabotegravir for PrEP
时间窗: 6 months
A 6 item questionnaire that explores the reasons a pharmacist is able to or not able to provide the service
Percentage of people feeling satisfied with cabotegravir long acting injectable for PrEP
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Percentage of patients who believe in certain facilitators for using the service(1 year)
- Number of HIV seroconversions(1 year)
- Percentage of pharmacists who believe in certain facilitators in providing the service(1 year)
- Number of STI(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 patients who believe in certain barriers for using the service(1 year)
研究者
Elyse Tung
Director of Clinical Services
Kelley-Ross & Associates, Inc.