CARE: Comprehensive Assessment of Real-world Effectiveness of F/TAF in Persons Who Use Drugs (PWUD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Adherence and Persistence Rates of Oral PrEP (F/TAF) Among Persons Who Use Drugs Over 12 Months
研究概览
简要总结
This study looks at how to help people who use drugs start and keep taking medicine that can prevent HIV. The medicine is called PrEP (pre-exposure prophylaxis). The study investigators will use a pill called Descovy (F/TAF), which is already approved by the FDA for HIV prevention.
People who come to the emergency department (ED) and test negative for HIV may join the study. Some participants will start taking PrEP and will be followed for one year. Other participants will only do an interview about their thoughts on PrEP. The study investigators will also talk to doctors and peer support workers in the ED to learn what makes it easier or harder to offer PrEP.
The main goal is to see how well PrEP can be started and continued for people who use drugs. The study investigators will look at how many people start PrEP, how many keep taking it, and what helps or makes it hard to stay on PrEP. The study investigators will also learn about the best ways to connect people to care after they leave the ED.
This study does not test if the medicine works to prevent HIV-that is already known. Instead, it looks at real-life challenges and solutions for using PrEP in this group. The study may help improve HIV prevention and health care for people who use drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prep Initiation Inclusion: 18 years of age or older; Communicate in English; Confirmatory test of HIV-negative; Documented or identified history of injection drug use within the last six-months or have documented or identified general drug use within the last twelve months; Be able to provide at least one contact person including name and phone number where participant can be reached for follow-up
- •Clinician Interview Inclusion: At least 18 years of age; Healthcare provider or peer navigator, a person with lived experience in substance use disorder who will help navigate the patient through care, currently employed in TGH ED
- •Interview Inclusion: At least 18 years of age; Communicate in English; Confirmatory test of HIV-negative; Documented or identified history of injection drug use within the last six-months or have documented or identified general drug use within the last twelve months;
排除标准
- •PrEP Initiation Exclusion: Under 18 years of age; Determined to be HIV-positive following confirmatory testing; Have a CrCl of less than 30ml/min, making them only eligible for long-acting injectable PrEP if CrCl is a limiting factor for oral PrEP; Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent; Are currently incarcerated or have pending legal action that may prevent an individual from completing the study; Pregnant.
- •Clinician Interview Exclusion: Under 18 years of age; Not currently employed as a healthcare provider or peer navigator in the TGH ED.
- •Interview Exclusion: Under 18 years of age; Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent; Are currently incarcerated or have pending legal action that may prevent an individual from completing the study;
研究组 & 干预措施
Clinician Interview
Collection clinician perceptions on PrEP
干预措施: PrEP perspectives (Other)
PrEP arm
patients receiving PrEP and being followed for 1 year
干预措施: PrEP adherence (Other)
PrEP arm
patients receiving PrEP and being followed for 1 year
干预措施: PrEP perspectives (Other)
Interview only group
patients who do not wish to receive PrEP and complete a single interview assessing why they do not want PrEP
干预措施: PrEP perspectives (Other)
结局指标
主要结局
Adherence and Persistence Rates of Oral PrEP (F/TAF) Among Persons Who Use Drugs Over 12 Months
时间窗: From enrollment through 12 months for patients who use PrEP. For the interview only group and clinician group, this information is collected at a single point in time when they are interviewed.
This outcome measures the proportion of participants who remain on oral PrEP (F/TAF) at 1, 2, 4, 8, and 12 months after initiation in the emergency department. Adherence will be assessed through self-report interviews. Persistence is defined as continued PrEP use without discontinuation during the 12-month follow-up period. This measure will help determine real-world feasibility of maintaining PrEP among persons who use drugs and identify barriers and facilitators to adherence.
次要结局
- Qualitative Themes Related to PrEP Initiation and Continuation(For PrEP using participants: enrollment through 12 months. For interview only and clinician groups: single interview session.)
- Identification and Enrollment of F/TAF Eligible Patients(Enrollment through 12 months.)
研究者
Heather Henderson
Assistant Professor, Emergency Medicine Director, Division of Social Emergency Medicine, Population and Global Health Program Director, Idea Exchange Tampa
University of South Florida