Understanding and Maximizing the Community Impact of Antimalarial Treatment (INDIE-SMC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,978
- 试验地点
- 1
- 主要终点
- Parasite prevalence by quantitative PCR (qPCR) at the end of the transmission season in age groups targeted by seasonal malaria chemoprevention.
研究概览
简要总结
Seasonal Malaria Chemoprophylaxis (SMC) is a fundamental component of malaria control. The SMC program involves that sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) is given to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. Yet, its efficacy is increasingly below expectations.
This study involves an Operational evaluation of a modified existing intervention and its implementation are prepared in direct interaction with the Ministry of Health (MoH) to tailor data collection to local needs. The main questions it aims to answer are:
- what are the reasons for the continued high infection rates in the SMC-targeted population;
- what are the implications for transmission of sub-optimal SMC in children less than 5 years old;
- can the impact of SMC be improved by including older age groups that would both expand the population that experiences direct chemoprophylactic benefits and concurrently reduce transmission to the wider community
Researchers will:
i) Compare SMC effectiveness as implemented by the national malaria control program and SMC implemented in a research context where all doses are directly observed.
ii) Quantify the infectious reservoir and the contribution of different age groups to transmission with conventional SMC (<5 years) and extended SMC (<10 years) iii) Determine the impact of drug resistance and drug absorption on SMC efficacy iv) Understand social barriers and enablers interfering with SMC efficacy and how SMC uptake is related to health equity with special attention to gender inequalities.
v) Quantify SMC efficacy decay under programmatic conditions and key drivers of this decay.
详细描述
Seasonal Malaria Chemoprophylaxis is a well established method of malaria control. Sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) is given to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. Whilst highly effective in controlled research studies, the impact of SMC in terms of reducing infection prevalence is less following operational delivery. It is currently unclear why and what drivers of SMC coverage and uptake play a role. In addition, the relative importance of parasite drug resistance, limited adherence, poor drug absorption and frequent re-infections remain largely unexplored.
Lastly, the World Health Organization has recently widened the scope for SMC to target all vulnerable populations. The Ministry of Health (MoH) in Burkina Faso is considering extending SMC to all children below 10 years of age; the impact of SMC on clinical incidence and parasite prevalence in this population with markedly different immunity is unknown. Moreover, this older age group is known to be highly relevant for onward malaria transmission, making it important to quantify the impact of SMC on the human infectious reservoir for malaria and broader benefits to the community.
The investigators propose a cluster-randomized trial in Saponé Health District, Burkina Faso, with three study arms:
i. SMC in children under the age of 5 years, implemented by the MoH without directly observed treatment for the full course of SMC ii. SMC in children under the age of 5 years, with directly observed treatment for the full course of SMC iii. SMC in children under the age of 10 years, with directly observed treatment for the full course of SMC The investigators will deliver the different arms of the intervention to 40 clusters of 3 households/compounds (i.e. 120 compounds per arm). The primary endpoint is parasite prevalence at the end of the malaria transmission season, secondary endpoints include the impact of SMC on clinical incidence, gametocyte carriage and potential for onward parasite transmission to mosquitoes. As relevant factors in determining these efficacies, drivers of SMC uptake and treatment adherence will be determined, as well as drug concentrations, parasite resistance markers and transmission of parasites to mosquitoes.
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
盲法说明
Laboratory analysis and impact analysis teams will be blinded to intervention arm.
Entomology staff involved in the mosquito feeding assays will be blinded for the parasitology results.
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Parasite prevalence by quantitative PCR (qPCR) at the end of the transmission season in age groups targeted by seasonal malaria chemoprevention.
时间窗: 4 weeks
This endpoint will be compared between arms 1 and 2 (in children aged 3-59 months) and arms 2 and arm 3 (in children aged 3 months-9 years).
次要结局
- Parasite prevalence by microscopy at the end of the transmission season in all age groups(4 weeks)
- Parasite prevalence by qPCR at the end of the transmission season in all age groups(4 weeks)
- Gametocyte prevalence by qRT-PCR at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups(10 weeks)
- Gametocyte prevalence by qRT-PCR at the end of the transmission season in all age groups(8 weeks)
- Parasite prevalence by microscopy prior to SMC rounds 2, 3 and 4 in SMC-targeted age groups(8 weeks)
- Rate of re-infection with P. falciparum at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups(10 weeks)
- Plasma levels of AQ and DESAQ after the 4th round of SMC in children aged 3 months-9 years(6 weeks)
- Clinical malaria incidence captured during passive-case detection (between arm comparison)(Across study period (6 months))
- Parasite prevalence by qPCR at the end of the transmission season compared between arms 1 and combined arms 2 + 3.(4 weeks)
- Gametocyte prevalence by qRT-PCR at the end of the transmission season in age groups targeted by SMC (comparison between arm1 and 2 (in children aged 3-59 months) and arms 2 and arm 3 (in children aged 5 years-9 years).(4 weeks)
- Parasite prevalence by microscopy at the end of the transmission season in all age groups(4 weeks)
- Parasite prevalence by qPCR at the end of the transmission season in all age groups(4 weeks)
- Parasite prevalence by microscopy prior to SMC rounds 2, 3 and 4 in SMC-targeted age groups(8 weeks)
- Rate of re-infection with P. falciparum at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups(10 weeks)
- Gametocyte prevalence by qRT-PCR at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups(10 weeks)
- Gametocyte prevalence by qRT-PCR at the end of the transmission season in all age groups(8 weeks)
- Plasma levels of AQ and DESAQ after the 4th round of SMC in children aged 3 months-9 years(6 weeks)