Sustainable East Africa Research in Community Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150,395
- 试验地点
- 3
- 主要终点
- HIV Incidence
研究概览
简要总结
The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP) in the context of universal treatment and streamlined care. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".
详细描述
The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP) in the context of universal treatment and streamlined care. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community Level Inclusion Criteria:
- •Non-adjacent geopolitical units in south-western and eastern Uganda and western Kenya.
- •Most recent census population between 9,000 and 11,000 individuals.
- •Served by an ART providing health center.
- •Community leader commitment for study participation and implementation.
- •Accessibility to health center via a maintained transportation route.
- •Community location with sufficient distance from other potential study communities to limit contamination of intervention or control conditions (buffer zone)
- •Individual Level Inclusion Criteria:
- •Residency of individual in community, defined as present in household for at least 6 months of the calendar year.
- •Community Level
排除标准
- •Presence of ongoing community-based ART intervention strategies that provide treatment outside of the current in-country treatment guidelines.
- •An urban setting defined as a city with a population of 100,000 or more inhabitants.
- •Absence of a health center able to provide ART.
研究组 & 干预措施
1st: universal test and treat; 2nd: targeted PrEP and cascade
Intervention arm first phase: annual universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery
Intervention arm second phase: baseline universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery + targeted PrEP, and targeted HIV testing interventions
干预措施: Universal ART in a streamlined care model (Other)
1st: universal test and treat; 2nd: targeted PrEP and cascade
Intervention arm first phase: annual universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery
Intervention arm second phase: baseline universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery + targeted PrEP, and targeted HIV testing interventions
干预措施: Annual Community Health Campaigns (Other)
1st: universal test and treat; 2nd: targeted PrEP and cascade
Intervention arm first phase: annual universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery
Intervention arm second phase: baseline universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery + targeted PrEP, and targeted HIV testing interventions
干预措施: Targeted PrEP and Targeted testing interventions (Other)
1st: baseline community testing; 2nd: None
Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care
干预措施: Universal ART in a streamlined care model (Other)
1st: baseline community testing; 2nd: None
Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care
干预措施: Baseline community-based HIV and multi-disease testing (Other)
结局指标
主要结局
HIV Incidence
时间窗: 3 years follow up
HIV incidence rate in men and women ages ≥15 years after the start of Phase II intervention (started after 3 years of Phase I).
Cumulative HIV Incidence
时间窗: 3 years follow up
Cumulative 3 year HIV incidence in men and women ages ≥15 years after the start of Phase I intervention. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
次要结局
- Prevalence of Transmitted HIV Drug-resistance Mutations(Baseline)
- Linkage to Care(30 days after HIV test)
- Incident TB Associated With HIV(3 years follow up)
- HIV-free Infant Survival(3 years follow up)
- Year 3 Viremia Among ART-experienced Persons With Baseline Viremia(3 years follow up)
- Total Costs of Programming (ART)(Follow up year 3)
- Average Adults' on- and Off-farm Employment(3 years follow up)
- HIV Incidence Rate(3 years follow up)
- Hypertension Control(3 years follow up)
- Overall Mortality(3 years follow up)
- Percent of HIV+ Adults With HIV RNA <=500 c/mL(3 years follow up)
- Time in Care for HIV+ Adults With Baseline Viremia(3 years follow up)
- Cumulative Incidence of ART-initiation(3 years follow up)
- Adherence to PrEP Treatment(3 years follow up)
- Prevalence of Chronic Kidney Disease (CKD)(3 years follow up)