Home Assessment and Initiation of ART: a Cluster-randomised Trial in Blantyre, Malawi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16,660
- 试验地点
- 2
- 主要终点
- ART Initiation
研究概览
简要总结
Despite increasing availability of antiretroviral therapy (ART) for HIV in high prevalence countries, the majority of people with HIV infection still initiate treatment at an advanced stage of disease. This leads to a high risk of death soon after HIV diagnosis. Prompt HIV diagnosis is, therefore, necessary for both individual and public health benefit and is being strongly promoted as international and national policy in Malawi. However timely HIV diagnosis may not in itself be sufficient to ensure ART initiation: this is reflected by the relatively high proportion of individuals who defer treatment-seeking for months or years following diagnosis of HIV.
Here the researchers investigate the extent to which home assessment and initiation of ART adds to the effectiveness of a home-based HIV testing and counseling strategy, using entry to, adherence with, and retention in HIV care as the outcome of interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Usual resident of an eligible cluster
- •Has had a positive HIV test (regardless of source) and requests facilitated access to HIV care from the resident community counsellor
- •Confirmatory HIV test is positive
- •No previous ART treatment, or less than one month's treatment in the past (including PMTCT interventions) and not currently receiving HIV care
- •No contraindications to receiving ART (as defined by Integrated Management of Adult Illnesses, HIV Department, WHO)
- •No acute danger signs requiring hospital referral
- •Aged 18 years or older
- •Written or witnessed informed consent to participate in the study
排除标准
- •Not a usual resident of an eligible cluster
- •No previous HIV test, or HIV infection not confirmed by home-based ART nurse
- •Already receiving ART, or has had more than 1 month's treatment in the past
- •Known contraindication to firstline ART (known hypersensitivity, renal failure, chronic liver disease)
- •Acute danger sign present (as defined by Integrated Management of Adult Illnesses, HIV Department, WHO)
- •Age younger than 18 years
- •Not willing to accept home-based ART initiation
- •Suspected or confirmed TB disease will not be an exclusion criteria, but will be an indication for deferral, until completion of the screening algorithm, with initiation of TB treatment if indicated.
结局指标
主要结局
ART Initiation
时间窗: First six months following introduction of home-based HIV testing
Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention.
次要结局
- Adult Mortality(The first 6-months following availability of home-based HIV testing)
- Uptake of Home-based HIV Testing(The first 6-months following home assessment and initiation of ART being made available)
- Reporting of HIV-positive Results(The first 6-months following availability of home-based HIV testing)
- Loss to Retention(The first 6-months following availability of home-based HIV testing)
- Adherence to ART(First 6-months following availability of home-based HIV testing)