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临床试验/NCT04167566
NCT04167566已完成不适用

Exploring 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 Research2 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,000
试验地点
2
主要终点
The rate of asymptomatic malaria parasitaemia among afebrile children aged 6 months to 15 years and adults in the Pakro sub district will be known.

研究概览

简要总结

Malaria poses a serious burden in sub-Sahara Africa. Efforts are ongoing to scale up interventions that work. These include the use of Long Lasting Insecticidal Nets (LLIN), Intermittent Preventive Treatment in children (IPTc), and test, treat and track (TTT). There is the need, however, 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 associated with MTTT in order to reduce the parasite load at baseline. MTTT of children in Ghana has demonstrated a parasite load reduction from 25% to 1%. However, unanswered questions include - could this be scaled up? What proportion of the community could be covered over a given time? What would it take to accomplish large scale MTTT? In designing interventions that aim at reducing the burden of malaria in children under five, for example, MTTT has largely been left out. Adults who are not often targeted by such interventions remain reservoirs that fuel transmission. This study explores the scale-up of interventions that work using existing community volunteer teams to lower cost. These volunteers will play a surveillance role by conducting home-based management of malaria. To avoid challenges posed by stockouts, short message service (SMS) will be used to monitor the level of stocks for malaria medicine and Rapid Diagnostic Tests (RDTs). It is hypothesized that there are more asymptomatic malaria cases (those who carry the parasite but are not ill) than symptomatic cases reported by hospital records in the Pakro sub district and that, carrying out MTTT in combination with home-based management of malaria in specific communities could greatly reduce the burden. Through this study, the bottlenecks that hinder scaling-up of MTTT will be documented in order to facilitate the process.

详细描述

Introduction/Rationale

The World Health Organization (WHO) in 2010 reported that malaria was endemic in 96 countries reflecting an improvement of the situation of 2005 where it was endemic in 106 countries. Malaria morbidity and mortality remain a serious problem in sub Saharan Africa especially in areas with holo-endemic transmission. 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 198 million with 584,000 deaths in 2013. 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 insecticide treated nets, long lasting insecticidal nets (LLIN), vectors surveillance and intermittent preventive treatment in pregnancy (IPTp) and implementation of the WHO policy on test, treat and track. Despite the reported decrease, most of the endemic countries across sub Saharan Africa still bear the greatest burden of the disease where 90% of the deaths are reported with more than 75% of the mortalities in children under five.

Ghana National Malaria Control Programme (GNMCP) reports reveal that in 2006 malaria accounted for 37.5% of all out patient consultations, 36.0% of all hospital admissions, and about 33.4% of all mortality in children under age five years. Following the recommendation of the WHO, Ghana changed it 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. Of those admitted for malaria, 63% were children under 5 years of age while pregnant women constituted 16.8%. Furthermore, According to the Ghana Health Service (GHS) report of 2012, malaria accounted for 22.4% deaths in children less than five years of age and 3.4% deaths among pregnant women. Over the last decade, 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 programmes for children under five could effectively clear more than 90% of the parasite in this age group.

Different studies have demonstrated very high level of asymptomatic malaria parasitaemia in both less than 5 years old and school age children. In 2009, Ahorlu et al, reported a parasite prevalence of 25% in less than five year old children in the Shime sub district in the coast of Ghana. In the same light, reported a malaria parasitaemia prevalence of 58.6% among school children in the Ejusu Juaben District, while reported a 41.5% prevalence of malaria parasitaemia in Ghanaian school children in the Ashainti and Upper West regions of the country. A related study in the Dodowa area demonstrated that children with high levels of asymptomatic parasitaemia have a higher risk of coming down with clinical malaria.

The link between one parasite carrier or infected individual and the next relies on the mosquito picking up the parasite during a blood meal. This means that even if all patients with malaria are treated of the disease, those individuals who carry the parasite and are not ill could redistribute it to the healthy population with the help of the mosquito and therefore, the cycle simply continues. The high incidence of asymptomatic parasitaemia serves as a reservoir that fuels the malaria transmission cycle. If the parasite is cleared from the blood of asymptomatic individuals as well as the sick patients with the very efficacious Artemisinin-based Combination Therapy (ACT), then, even the most effective mosquito vector would have nothing to transmit following a blood meal.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
2 Months 至 15 Years(Child)
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 cohort 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

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).

结局指标

主要结局

The rate of asymptomatic malaria parasitaemia among afebrile children aged 6 months to 15 years and adults in the Pakro sub district will be known.

时间窗: Once every 4 months, over a period of 24 months

The change in the rate of asymptomatic parasistaemia at evaluation compared to baseline. This will be determined by testing for the presence of malaria parasite in healthy participants without a history of fever in the last 48 hours before an intervention. This will be done using rapid diagnostic test. The temperature will be taken before the the test to ensure that the patients are not febrile. Questionnaires will be used to collect data on the prevalence of febrile illnesses.

The list of challenges that needs to be addressed to enable scale-up of MTTT interventions feasible in Ghana.

时间窗: 24 months

This outcome will provide a list of challenges faced by the investigators during the implementation of MTTT. It will also state how many challenges were addressed and at what level. A detailed description will be made of how each challenge was addressed at the level of the community, administration and stakeholders. Data will be collected from field notes taken during monthly monitoring visits, field reports, interviews and focus group discussion.

The proportion hospital admissions due to malaria that are averted as a result of MTTT implementation will be determined.

时间窗: 24 months

The effect of MTTT on hospital admissions in the intervention communities will be evaluated by comparing the proportion of confirmed malaria cases during the MTTT intervention period to the proportion of confirmed malaria cases period before implementation of the MTTT intervention at the Pakro Health Centre. Data on malaria test results will be collected from hospital registers. The proportion will be defined as (number of confirmed malaria cases/number of participants tested for malaria) \*100. Questionnaires, focus group discussions and In-depth interviews will be used to gather complementary information to obtain a holistic picture of the effect of the interventions in the community.

次要结局

  • The cost benefit analysis of the scaling up MTTT intervention in the area will be known.(24 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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