Impact of Mass Screening and Selective Treatment With Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in High Endemic Area, Belu Regency, Nusa Tenggara Timur Province, Indonesia: a Randomized Cluster Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,488
- 试验地点
- 1
- 主要终点
- Malaria incidence
研究概览
简要总结
Mass Drug Administration (MDA) and Mass Screening and Selective Treatment (MST) might be applied as strategies for eliminating malaria when focusing on transmission stages. Many studies either with MDA or MST has been done in low transmission areas demonstrated the impact of those activities to reduce malaria transmission. However, in high transmission such study is still very limited which is becoming the reason behind this study.
A randomized cluster trial of MST study using dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) will be conducted in some villages at the Belu regency, Nusa Tenggara TImur province, Central Indonesia. There will be three arms in the study, i.e. (1) intervention arm of mass screening and treatment with interval of 6 weeks; (2) intervention arm of mass screening and treatment with interval of 3 months and (3) control arm without mass screening and treatment. The intervention arm with 6 weeks interval represents a new proposed method to detection malaria infections, while the intervention arm with 3 month interval represents the Ministry of Health current policy of active case detection in Indonesia, and the third arm will serve as the control for Ministry of Health's policy.
The study will be conducted in 6 months period and evaluate various parameters including malaria incidence and proportion of anemia in monthly cohort school children (in arm1, 2 and 3), in addition to malaria prevalence in the community (only in arm 1 and arm 2). All positive subject in all arms will receive supervised treatment. Secondary objectives are the proportion of gametocytemia in the community, the proportion of malaria antibody of various age groups, population genetic of local parasite, submicroscopic incidence based polymerase chain reaction and the proportion of infective mosquitoes. Data analysis will be performed according to the method for cluster randomized trial evaluation.
详细描述
Study Site
The study will be conducted at Belu regency (south latitude 90 - 100; east longitude 1240- 1260) which located in the Nusa Tenggara Timur province, central part of Indonesia.
Atambua District Health Office reported that most of high endemic malaria areas were situated in the southern part of the regency in 2011. The highest Annual Parasite Incidence (API) reported was in the subdistrict of Wewiku (72.1 cases/1,000 people). Therefore, this study will focus in high case incidence of villages in Wewiku sub-districts.
Study design overview and demographic census
The study design is "randomized cluster trial" by microscopic malaria screening at high malaria incidence at village level. Two-four villages with malaria prevalence of >8% or sub-villages with malaria prevalence > 10% in school children will be selected as study villages or sub-villages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All villagers of the all selected clusters
排除标准
- •Pregnant women during their first trimester
- •Single dose primaquine should not be given for infants less than 1 year-old, pregnant women in all trimesters of pregnancy, breast-feeding mother and patients with G6PD deficiency
研究组 & 干预措施
DHP monthly
Three mass screening and selective treatment using dihydroartemisinin-piperaquine and primaquine i.e. on month 1 (MST1), month 2 (MST2), and month 3 (MST3) with an interval of 6 weeks between each MST
干预措施: dihydroartemisinin-piperaquine (Drug)
DHP monthly
Three mass screening and selective treatment using dihydroartemisinin-piperaquine and primaquine i.e. on month 1 (MST1), month 2 (MST2), and month 3 (MST3) with an interval of 6 weeks between each MST
干预措施: primaquine (Drug)
DHP bi-monthly
Two mass screenings and selective treatment using dihydroartemisinin-piperaquine and primaquine i.e. on month 1 (MST1) and month 3 (MST3) with an interval of 3 months.
干预措施: dihydroartemisinin-piperaquine (Drug)
DHP bi-monthly
Two mass screenings and selective treatment using dihydroartemisinin-piperaquine and primaquine i.e. on month 1 (MST1) and month 3 (MST3) with an interval of 3 months.
干预措施: primaquine (Drug)
结局指标
主要结局
Malaria incidence
时间窗: 6 months
Malaria incidence in children at the elementary schools (all arms)
次要结局
- Anemia(6 months)
研究者
Inge Sutanto
Prof. DR. dr.
Indonesia University