A Cluster Randomised Trial Comparing the Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence. The ARNS 12249 TasP (Treatment as Prevention) Trial in Hlabisa Sub-district, KwaZulu-Natal, South Africa.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28,153
- 试验地点
- 2
- 主要终点
- Uptake of initial and repeat HIV counselling and testing (Feasibility phase)
研究概览
简要总结
This trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level.
The proposed strategy is a two steps process:
- Extensive HIV counselling and testing, and comprehensive prevention programme among a target population
- Immediate ART initiation after HIV diagnosis, irrespective of CD4 count criteria.
The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the population. This is a cluster randomised controlled trial with a total of 22 communities used as the units for randomisation. Enrolment of a population of 22 000 individuals among which 4 400 are expected to be HIV-Infected.
详细描述
The trial objective is to estimate the effect of ART initiated immediately after HIV diagnosis on the reduction in incidence of new HIV infections in the general population. It will be conducted in two phases:
- First phase: aiming to evaluate the feasibility and acceptability of extensive HIV testing and early ARV treatment initiation on a subset of the target population (Hlabisa sub-district in KwaZulu Natal, South Africa); completion on February 2014.
- Second phase: full implementation of the trial in the target population from May 2014.
The proposed intervention has two components :
-
Component 1 "Test": HIV counselling and testing, and comprehensive prevention programme among the entire target population
-
Component 2 "Treat": ART treatment initiation for HIV infected individuals following two strategies
-
control group: ART initiation when eligible for treatment as per WHO guidelines
-
intervention group: immediate ART initiation regardless of immunological and clinical staging
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 16 and more
- •Member of a household in the designated cluster within the Hlabisa sub-district of KwaZulu Natal in South Africa
- •Able and willing to give written informed consent for trial participation and/or HIV counselling and testing
排除标准
- 未提供
研究组 & 干预措施
Immediate ARV treatment initiation
Initiation of ARV treatment regardless of participants's immunological and clinical staging
干预措施: Immediate ARV treatment initiation with TDF/FTC/EFV (Drug)
South African recommendation guided ARV initiation
HIV-infected individuals will be assessed clinically and immunologically and when eligible for treatment as per South African guidelines will be offered ART
干预措施: South African recommendation guided ARV (TDF/FTC/EFV) initiation (Other)
结局指标
主要结局
Uptake of initial and repeat HIV counselling and testing (Feasibility phase)
时间窗: 14 months
Percentage of the target population tested for HIV
Uptake of ARV treatment among HIV-infected individuals (Feasibility phase)
时间窗: 14 months
Percentage of HIV-infected patients followed-up in the trial clinics receiving ARV treatment when eligible
HIV infection incidence
时间窗: 4 years after enrolment initiation
Serology will be done on Dry Blood Spot collected during repeated surveys
次要结局
- Quality of life(Repeated measure every 6 months during follow-up)
- Health care use and health care expenditures(Repeated measure every 6 months during follow-up)
- Safe sex and condom use(Repeated measure every 6 months during follow-up)
- Sexual partnerships(Repeated measure every 6 months during follow-up)
- Stigma at community level(Repeated measure every 6 months during follow-up)
- Adherence to ART(Repeated measure every 6 months during follow-up)
- Retention(Repeated measure every 6 months during follow-up)