Home-based Interventions to Test and Start (HITS): a Cluster-randomized Controlled Trial to Reduce Mortality and Incidence Through HIV Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 4,667
- 试验地点
- 1
- 主要终点
- Population-level HIV-related mortality in men
研究概览
简要总结
This study aims to establish the causal impact of two interventions - micro-incentives and a male-sensitive HIV- specific decision support app - on population-level HIV viral load and HIV-related mortality in men, as well as on population-based HIV incidence in young women.
详细描述
Research aim:
The primary aim of the home-based intervention to test and start (HITS) trial is to establish whether (i) the provision of two micro-incentives and (ii) a male-sensitive and HIV-specific decision support app will reduce population-level HIV viral load and HIV-related mortality in men, as well as population-level HIV incidence in young women.
Specific objectives
-
Establish the causal impact of two micro-incentives (aimed at increasing uptake of home-based HIV testing and linkage to care, respectively) on:
-
Population-level HIV viral load in men
-
Population-level HIV-related mortality in men
-
Population-level HIV incidence in young women.
-
Establish the causal impact of a male-sensitive and HIV-specific decision- support app (called EPIC-HIV) on:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •15 years old and above
- •Resident members of households within the Population Intervention Platform
- •Have consented to participate in Population Intervention Platform
- •additional eligibility criteria for EPIC-HIV
排除标准
- •Refused to take part in Population Intervention Platform
- •Participant reported to already be on ART
研究组 & 干预措施
micro-incentives
micro-incentives only (8 communities)
干预措施: micro-incentive (Behavioral)
EPIC-HIV
Empowered through informed choice for HIV [male sensitive HIV specific decision support app] (males only in 8 communities)
干预措施: EPIC-HIV (Behavioral)
micro-incentive and EPIC-HIV
micro-incentives as well as EPIC [male sensitive HIV specific decision support app] (8 communities)
干预措施: micro-incentive and EPIC-HIV (Behavioral)
control
standard of care
结局指标
主要结局
Population-level HIV-related mortality in men
时间窗: year 3
Change in HIV-related mortality rate measured as the number of HIV-related deaths per 1000 person-years of observation in men
Population-level HIV incidence in young women (15-30 years of age)
时间窗: year 3
Change in HIV incidence rate (number of HIV sero-conversions per 100 person-years of follow up) in young women; HIV testing and viral load measurements are performed on the DBS samples collected during the annual survey
HIV testing uptake at point of test offer in men
时间窗: Baseline
% received the rapid HIV test at home among those offered the test in men
HIV treatment linkage at 1 year in men
时间窗: year 1
% who visited study clinics and initiated antiretroviral therapy (ART) in men
Population-level HIV viral suppression in men
时间窗: year 1
Change in proportion with detectable viremia in men; HIV testing and viral load measurements are performed on the dried blood spot (DBS) samples collected during the annual survey
次要结局
- HIV treatment linkage at 1 year in women(year 1)
- Retention in HIV care in men and women(year 3)
- HIV testing uptake at point of test offer in women(Baseline)
- Population-level HIV viral suppression (both sexes)(year 3)
- Population-level HIV viral suppression in women(year 3)
- Population-level HIV incidence in men(year 3)
- HIV prevention knowledge in men and women(year 1)
- Household wealth (food security)(year 3)
- Partnership patterns in men and women(year 1)
- Population-level HIV viral suppression in men(year 3)
- Population-level all-cause mortality (both sexes)(year 3)
- Reported condom use in men and women(year 1)
- Hypertension healthcare utilization in men and women(year 1)
- Population level HIV incidence (both sexes)(year 3)
- Population-level HIV-related mortality (both sexes)(year 3)
- Population-level HIV-related mortality in women(year 3)
- HIV status knowledge in men and women(year 1)
- HIV treatment utilization in men and women(year 1)
- Patient viral suppression in men and women(year 3)
- Tuberculosis (TB) healthcare utilization in men and women(year 1)
- Diabetes Healthcare utilization in men and women(year 1)
- Household wealth (household assets)(year 3)
- Population-level HIV viral suppression (both sexes)(year 1)
- Population-level HIV viral suppression in women(year 1)
- Retention in HIV care in men and women(year 1)
- Patient viral suppression in men and women(year 1)
研究者
Frank
Professor
Africa Health Research Institute