Vicente Ferrer HIV Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The VFHCS is a long-term prospective cohort study of HIV infected patients from a resource-poor rural setting in India. The aim of the study is to use data collected from routine clinical care in order to describe the epidemiology of HIV and its related conditions in the investigators area, and to study the effectiveness of health interventions in a "real-world" setting (implementation and operational research).
详细描述
Andhra Pradesh is the state with highest burden of HIV in India. Anantapur is a district situated in the South border of Andhra Pradesh with 72% rural population and adult literacy rate of 74.1% in men and 54.3% in women. In Anantapur, the HIV epidemic is largely driven by heterosexual transmission and it is characterized by poor socioeconomic conditions and high levels of illiteracy.
Rural Development Trust (RDT) is a nongovernmental organization, which provides medical care to people living with HIV free of charge, including medicines, consultation and admission charges. In Bathalapalli Hospital, outpatient clinics and 71 beds are allocated exclusively for HIV or tuberculosis infected patients.
The Vicente Ferrer HIV Cohort Study (VFHCS) is a prospective open cohort study of all HIV infected patients who have attended Bathalapalli RDT Hospital. Routine clinical data from patients are collected prospectively since September 2009 and entered in a SQL-server database using C# as front end. Details of route of transmission, HIV associated risk factors and socio-demographic data are collected at enrolment. Data collected include medical treatment (antiretroviral treatment and other medications), laboratory investigations (haemogram, renal function tests, liver function tests, CD4 lymphocyte count, bacterial infections), and standardized diagnoses.
The objective of the VFHCS is to describe social and medical aspects related to HIV in the investigators setting, including:
- Epidemiology: trends in HIV incidence, transmission mechanisms, socioeconomic risk factors associated with HIV.
- Incidence and prevalence of opportunistic infections, especially tuberculosis and cryptococcosis.
- Life expectancy and factors associated with mortality
- Describe the retention across the continuum of care and investigate factors associated with loss to follow-up.
- Toxicity and effectiveness of antiretroviral therapy.
- Effectiveness of programmes to prevent mother to child transmission.
- Incidence and prevalence of non-communicable diseases such as cancer or cardiovascular diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive serology for HIV
排除标准
- •Refuse to consent
结局指标
主要结局
Mortality
时间窗: Time to event methods will be used. Participants will be followed from HIV diagnosis until death, assessed up to 30 years
Survival since diagnosis of HIV infection
次要结局
未报告次要终点
研究者
Gerardo Alvarez-Uria
Head of the Department of Infectious Diseases
Rural Development Trust Hospital