Operational Research for Cryptococcal Antigen Screening to Improve ART Survival
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,049
- 试验地点
- 2
- 主要终点
- Retention in care
研究概览
简要总结
This will be a stepped wedge randomized trial design to evaluate the implementation of cryptococcal antigen (CRAG) screening and preemptive anti-fungal therapy of HIV-infected persons entering antiretroviral therapy (ART) outpatient treatment in Uganda. Those who are ART eligible with a CD4≤100 cells/mcL will have a serum/plasma CRAG performed by lateral flow assay. Those who are CRAG-positive and asymptomatic will be treated with high dose fluconazole. After 6 months survival with retention-in-care will be compared between those who are CRAG+ and CRAG negative
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection
- •CD4≤100 cells/mcL
- •Cryptococcal antigen (CRAG) positive
- •age >14 years
排除标准
- •Suspected Cryptococcal meningitis
- •Prior known history of cryptococcal meningitis
- •currently receiving HIV antiretroviral therapy
- •Allergy to any azole antifungal medication
- •Persons with known serious hepatic co-morbidities, transaminitis, or clinical jaundice who should not receive fluconazole in the opinion of the study investigator.
- •Current known pregnancy
研究组 & 干预措施
CrAg Screening and Fluconazole
Cryptococcal Antigen (CrAg) Screening with preemptive antifungal treatment per World Health Organization (WHO) guidelines. Randomized Stepped Wedge design of phased implementation.
干预措施: Fluconazole (Drug)
结局指标
主要结局
Retention in care
时间窗: 6-month
1. before/after CRAG screening implementation (All persons) 2. CRAG positive persons treated with high-dose fluconazole as compared to 6-month survival of CRAG negative persons who are eligible for antiretroviral therapy.
次要结局
- Percentage of participants with symptomatic cryptococcal meningitis(baseline)
- All-cause discontinuation of fluconazole(6-month)
- Cryptococcal meningitis-free survival time(6-month)
- Survival Time(6-month)
- Uptake of CRAG screening and preemptive treatment(baseline)
- Time from CRAG+ test to receipt of fluconazole therapy(Days from CD4 testing)
- Risk factors for symptomatic cryptococcal meningitis(baseline)