Home-based Plus Self-testing to Improve HIV Testing Coverage in Rural Lesotho - a Cluster Randomized Controlled Trial in Rural Lesotho.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- HIV testing coverage
研究概览
简要总结
This cluster-randomized trial aims to evaluate the efficacy of the use of oral HIV self-testing (HIVST) among individuals who are absent or who decline HIV testing during home-based HIV testing
详细描述
By launching the 90-90-90 strategy UNAIDS has shown a way forward in controlling and finally eradicating the deadly AIDS epidemic. Recent global data shows that progress towards the first UNAIDS target, i.e. to ensure that 90% of HIV-positive individuals are aware of their status, is lower than progress in other areas of the HIV care cascade. It is estimated that still approximately 2.7 million HIV-positive people do not know their HIV status.
Home- or community-based HIV testing has been proven to be very effective in resource-limited settings and therefore is a key strategy endorsed by WHO. Although acceptance of testing during such campaigns is usually very high, coverage remains low due to absent household members. And usually these absent people are men and young adults - both of which have a disproportionately high risk of HIV acquisition and poorer clinical outcomes once infected.
Oral HIV self-testing (HIVST) has shown to be an accurate diagnostic tool with a high acceptance and feasibility in sub-Saharan Africa. Experiences from the sub-Saharan region suggest that when HIV self-testing is provided as part of a home-based HIV testing campaigns, it can increase uptake of testing and facilitate linkage to care, especially among individuals who are at high risk of HIV infection.
The HOSENG study is linked to a follow-up trial, the VIBRA study. Together they are called the GET ON ("GETing tOwards Ninety") research project. The HOSENG study with its home-based HIV testing campaign provides the platform for the VIBRA study.
The HOSENG study is a cluster randomized, parallel-group (1:1:1:1 allocation), open-label, superiority, prospective clinical trial. Clusters are stratified by district, size of village, and village access to the nearest health facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
HIV testing coverage
时间窗: within 120 days after enrolment (i.e. HTS campaign)
HIV testing coverage among individuals aged 12 years or older in the surveyed area within 120 days after the HIV testing and service (HTS) campaign, defined as the proportion of all individuals 12 years or older living in a household of the surveyed area with a confirmed HIV test result
次要结局
- HIV testing coverage among adolescents and young adults (ADORE nested study outcome)(within 120 days after enrolment (i.e. HTS campaign))
- Blood-based HIV testing uptake(at enrolment (i.e. HTS campaign))
- Overall HIV testing coverage(within 120 days after enrolment (i.e. HTS campaign))
- Oral HIVST uptake using OraQuick(at enrolment (i.e. HTS campaign) and within 120 days after enrolment (i.e. HTS campaign))
研究者
Tracy Glass
Head of Statistics, Principal Investigator
Swiss Tropical & Public Health Institute
