Impact of Rapid ART Initiation on Retention in Care in the Southern US
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Retention in Care
研究概览
简要总结
Impact of Rapid ART Initiation on Retention in Care in the Southern US
Specific Goals and Aims:
The major goal for this study is to determine if rapid start of antiretroviral (ART) therapy increases retention in HIV medical care. The investigators hypothesize that there will be an increase in retention in care with rapid start, by removing barriers that would normally delay enrollment in a treatment program and enforce the importance of linkage to care and ART initiation from diagnosis.
In order to test this hypothesis, the investigators have the following specific aims for their proposed study:
- Study retention in care after rapid ART start in comparison to standard of care.
- Analyze risk factors for decreased retention in care, with focus on high-risk populations.
- Analyze potential demographic and geographic determinants of retention in care.
- Generate retention in care data in a Southern US state.
The investigators hypothesize the introduction of rapid start ART, as well as the introduction of care navigators, will lead to improved clinical outcomes, including retention in care at one year, viral suppression at one year, time to viral suppression, and time to first missed appointment. In the event rapid start ART fails to have a positive impact on clinical outcomes, the results of this study will still positively contribute to the knowledge gap, since there is a scarcity of data in the Southern United States, specifically in high-risk populations, such as racial and ethnic minorities, youth, and patients co-infected with hepatitis C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
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
- •Prospective arms: Human subjects ≥18 years old, newly diagnosed with HIV who are establishing care at the 550 Clinic.
- •Retrospective arm: Human subjects ≥18 years old, newly diagnosed with HIV who established care at the 550 Clinic and were treated with ART between 2012-2019.
排除标准
- •Pregnancy
- •Prior HIV diagnosis or exposure to ART
- •Medical necessity for therapy with ART agent other than bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), such as drug allergy, drug-drug interactions, creatinine clearance <30.
结局指标
主要结局
Retention in Care
时间窗: 12 months
Retention in HIV care at one year after initiation of rapid ART start, defined as 1) keeping at least 3 visits within the first 12 months of care and 2) attending a clinic visit between months 9-15 of the 12-month mark and 3) experiencing no gaps in care greater than 6 months.
次要结局
未报告次要终点
研究者
Bailey Benidir, PharmD
Clinical Pharmacist
University of Louisville