跳至主要内容
临床试验/NCT04301531
NCT04301531已完成不适用

Determining the Impact of Scaling up Mass Testing, Treatment and Tracking on Malaria Prevalence Among Children in the Pakro Sub District of Ghana

Noguchi Memorial Institute for Medical Research1 个研究点 分布在 1 个国家目标入组 5,861 人开始时间: 2020年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
5,861
试验地点
1
主要终点
The effect of MTTT/home-base management of malaria on malaria prevalence in children

研究概览

简要总结

Globally, malaria prevalence in 2016 was reported to have increased with 445,000 deaths, 91% of which occurred in sub-Sahara Africa with more than 75% being children. Individuals who carry the malaria parasite can either be symptomatic (showing signs and symptoms) or asymptomatic (without signs and symptoms). Asymptomatic malaria parasitaemia pose a very serious threat to malaria control efforts as they serve as reservoirs that fuel the transmission process. Therefore, interventions that target community-wide clearance of asymptomatic parasitaemia can drastically reduce malaria prevalence in the population and lead to elimination especially in endemic areas. Mass parasite clearance can deplete the parasite reservoirs and lower the transmission potential.

Efforts are ongoing to scale-up interventions that work such as use of Long Lasting Insecticidal Nets (LLIN), Intermittent Preventive Treatment in children (IPTc), and test, treat and track (TTT). However, there is need for mass testing, treatment and tracking (MTTT) of the whole population to reduce the parasite load before implementing the aforementioned interventions. Though, Seasonal Malaria Chemoprophylaxis (SMC) is adopted for selected localities in Ghana, the impact of such interventions could be enhanced, if combined with MTTT at baseline to reduce the parasite load. IPT of children in Ghana has demonstrated a parasite load reduction from 25% to 1%. However, unanswered questions include - could this be scaled up? What can be the coverage? What is needed for MTTT scale -up? In a pilot in Ghana, a coverage of more than 75% was achieved in target communities and reduced asymptomatic parasitaemia by 24% from July 2017 to July 2018. It is important to generate time series data to better analyse and understand the prevalence trends as well as the bottlenecks.

In designing interventions that aim at reducing the burden of malaria in children under five, for example, MTTT has largely been left out. This study explores the scale-up of interventions that work using community volunteers, hypothesising that implementing MTTT complemented by community-based management can reduce the prevalence of asymptomatic malaria parasite carriage in endemic communities. The effect of the interventions will be observed by comparing baseline data to evaluation data. This study will document the challenges and bottlenecks associated with scaling-up of MTTT to inform future efforts to scale-up the intervention.

详细描述

Background Malaria continues to pose a serious burden to the local populations in sub-Sahara Africa. Several efforts have been made to scale up interventions that work such as preventing man-vector contact, intermittent preventive therapy, seasonal malaria chemoprophylaxis as well as TTT for febrile patients. However, much still has to be done to target the mass testing, treatment and tracking of whole populations in order to reduce the parasite load before implementing the above mentioned interventions. Though SMC is adopted for selected localities in Ghana, MTTT could be used to drastically bring down the parasite load in a given population before the implementation of interventions such as SMC. Elsewhere, it has been demonstrated that incorporating the antimalarials in vaccination programmes could delay the first malaria episode in children under five. Furthermore, IPT of children in a community in Ghana has been reported to reduce the parasite load in a given community from 25% to 1%. The questions that remain are - could this be scaled up? What proportion of the community could be covered over a given time? What is needed to accomplish MTTT in large scale? In an ongoing pilot study in Ghana, a coverage of more than 75% was achieved in the target communities and a reduction of 24% in asymptomatic parasitaemia prevalence from July 2017 to July 2018. This proposal is intended to validate the findings of the pilot study.

In designing interventions that aim at reducing the burden of malaria in children under five, e.g, MTTT could be used to clear parasites from the general population before the interventions are implemented. This is because the adults who are not often included in the interventions that target children under 5 years old tend to act as reservoirs that fuel the transmission. To solve the problem of personnel who are limited at the level of the health service and coverage, this study will be making use of the existing network of community health workers (CHWs) that are used during vaccination programmes. The CHWs who reside in the communities, will carry out interventions in their communities and conduct the home-based management of malaria to reduce cost. To solve the problem of stock-outs of RDTs and ACTs, mobile phones SMS will be used. Monthly monitoring and of the volunteers. The volunteers will be trained based on the 2014 Ghana National Malaria Treatment Guidelines for managing uncomplicated malaria.

The study hypotheses that in the Pakro sub district, there are more asymptomatic malaria cases than the symptomatic cases reported by hospital records and that if MTTT is carried out in combination with home-based management of malaria in specific communities over two years, a large proportion of the parasite reservoir will be cleared and consequently open up possibilities for pre-elimination of malaria in the area. It is also intended that the bottlenecks involved in scaling up mass testing, treatment and tracking will be documented in order to facilitate the process.

Over the last decade, the number of recorded malaria cases has steadily dropped from 247 million cases with 881,000 deaths reported in 2006 to 216 million with 445,000 deaths in 2016 (WHO, 2009, 2010, 2016). This has largely been due to the introduction of ACTs following the resistance witnessed against chloroquine as well as an increase in the number of control measures such as the use of long lasting insecticidal nets (LLIN) and intermittent preventive treatment in pregnancy and children. Despite the reported decrease, sub Saharan Africa still bears the greatest burden of the disease where 90% of the deaths are reported with more than 75% of the mortalities in children under five.

Following the recommendation of the WHO, Ghana changed its malaria treatment guidelines adopting artesunate and amodiaquine as first line for the treatment of uncomplicated malaria to replace chloroquine. By 2012, hospital statistics across the country revealed that malaria was responsible for 38.93% of the outpatient consultations and 38.80% of admissions. Studies in Ghana have demonstrated that artesunate and amodiaquine combinations are not only efficacious in clearing the malaria parasites from patients but if used for intermittent preventive treatment for children under five could effectively clear more than 90% of the parasite in this age group.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
2 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Overall inclusion criteria for MTTT:
  • Be aged 2 months or older
  • Be resident in the study area
  • Have completed and signed the consent for adults or assent form for children 12-17 years.
  • Inclusion Criteria for children in the subgroup study:
  • Be age range 6 months to 14 years
  • Be resident in the study area for the period of the study.
  • Be willing to participate
  • Parent or guardian have completed and signed consent form
  • Provided assent for children 12-17 years

排除标准

  • If an individual intents to stay less than one year in the study site
  • Be absent at some time because he/she is schooling in a boarding school
  • Has a life threatening illness (excluding malaria).

研究组 & 干预措施

Arm 2 (control arm)

Other

Arm 2 or the Control arm will involve 2 communities: mass screening and treatment only done at baseline and at evaluation. Febrile cases will be tested and treated by CHWs any time.

干预措施: Mass testing using RDTs (Other)

Arm 1 (intervention arm)

Experimental

Arm 1 or the intervention arm will involve seven communities: 4-monthly mass screening, and treatment of those who test positive by CHWs will be conducted. Febrile cases will be tested and treated by CHWs any time

干预措施: Mass testing using RDTs (Other)

Arm 1 (intervention arm)

Experimental

Arm 1 or the intervention arm will involve seven communities: 4-monthly mass screening, and treatment of those who test positive by CHWs will be conducted. Febrile cases will be tested and treated by CHWs any time

干预措施: Treatment for all cases confirmed positive malaria cases with ACTs (Drug)

Arm 1 (intervention arm)

Experimental

Arm 1 or the intervention arm will involve seven communities: 4-monthly mass screening, and treatment of those who test positive by CHWs will be conducted. Febrile cases will be tested and treated by CHWs any time

干预措施: Determination of Hb (Other)

Arm 1 (intervention arm)

Experimental

Arm 1 or the intervention arm will involve seven communities: 4-monthly mass screening, and treatment of those who test positive by CHWs will be conducted. Febrile cases will be tested and treated by CHWs any time

干预措施: Household survey (Other)

Arm 1 (intervention arm)

Experimental

Arm 1 or the intervention arm will involve seven communities: 4-monthly mass screening, and treatment of those who test positive by CHWs will be conducted. Febrile cases will be tested and treated by CHWs any time

干预措施: Community-base management of malaria (Other)

Arm 2 (control arm)

Other

Arm 2 or the Control arm will involve 2 communities: mass screening and treatment only done at baseline and at evaluation. Febrile cases will be tested and treated by CHWs any time.

干预措施: Treatment for all cases confirmed positive malaria cases with ACTs (Drug)

Arm 2 (control arm)

Other

Arm 2 or the Control arm will involve 2 communities: mass screening and treatment only done at baseline and at evaluation. Febrile cases will be tested and treated by CHWs any time.

干预措施: Determination of Hb (Other)

Arm 2 (control arm)

Other

Arm 2 or the Control arm will involve 2 communities: mass screening and treatment only done at baseline and at evaluation. Febrile cases will be tested and treated by CHWs any time.

干预措施: Household survey (Other)

Arm 2 (control arm)

Other

Arm 2 or the Control arm will involve 2 communities: mass screening and treatment only done at baseline and at evaluation. Febrile cases will be tested and treated by CHWs any time.

干预措施: Community-base management of malaria (Other)

结局指标

主要结局

The effect of MTTT/home-base management of malaria on malaria prevalence in children

时间窗: 2 years

The difference in asymptomatic malaria parasitaemia prevalence in children \<15 years in the intervention arm compared to the control arm.

次要结局

  • Prevalence of febrile illnesses(2 years)
  • Cost benefit analaysis of implementing MTTT(2 years)
  • Prevalence of anaemia in <15 children(2 years)
  • Prevalence of asymptomatic malaria parasitaemia among household members(2 years)
  • Difference in symptomatic malaria cases attending health facilities(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Determining the Impact of Scaling up Mass Testing,... | 临床试验