CD4 Cell Count at Antiretroviral Therapy Initiation or Re- Initiation (CAIR)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Cross-sectional
研究概览
简要总结
The primary purpose of this study is to assess the burden of advanced HIV disease (CD4 cell count <200 or <350 cells/μL) among new patients and those returning to care after a gap in treatment, and the extent to which low coverage of CD4 cell count measurement among these patients may prevent adequate management of those with advanced HIV disease.
详细描述
This study is part of a multi-regional IeDEA study across four African regions to assess the burden of advanced HIV disease among PLWH at ART initiation and re-initiation. Among adults and adolescents. The WHO defines advanced HIV disease as having a CD4 cell count <200 cells/uL or having WHO stage 3 or 4 disease. In the region, the aim is to enrol 500 participants aged 18 years and older and to conduct a cross-sectional evaluation that will include assessments of WHO clinical stage, CD4 cell count, and ART exposure status at enrolment/re-enrolment into care, as well as barriers to HIV testing and care.
In addition, extraction of routinely collected clinical data on all study participants from within the cohort dataset, including prospective data on participant treatment outcomes, and CD4 and HIV VL measurements performed as part of routine patient care. These data will be harmonized using the IeDEA-DES, which is a common data model for sharing observational HIV data designed and maintained by the Data Harmonization Working Group (DHWG) of IeDEA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults aged ≥18 years who are willing and able to provide consent and are: newly enrolling in HIV care and starting ART at study sites OR
- •re-enrolling after a known ≥24-month ART gap confirmed by clinic records or patient recall at eligibility screening.
排除标准
- •Patients known to be on ART for more than 7 days at the time of assessment for enrollment into study.
- •Patients with a gap in ART that is <24 months.
- •Patients with a gap in ART of unknown duration
结局指标
主要结局
Cross-sectional
The investigators will conduct a cross-sectional evaluation that will include assessments of WHO clinical stage, CD4 cell count, and ART exposure status at enrolment/re-enrolment into care, as well as barriers to HIV testing and care
次要结局
未报告次要终点