CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,861 enrolled
Drug / intervention
Treatment for all cases confirmed positive malaria cases with ACTs +4 moredrug
Likely dose
Not stated in record
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Search/NCT04301531
NCT04301531N/ACompleted

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 Research·interventional·Posted Mar 10, 2020·Updated May 6, 2023

In Brief

A clinical study evaluating Mass testing using RDTs, Treatment for all cases confirmed positive malaria cases with ACTs, and 3 other interventions for Malaria Asymptomatic Parasitaemia. Completed, enrolled 5,861 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGhana

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 10, 2020
Enrollment StartMar 1, 2020
Primary CompletionNov 30, 2021
Study CompletionJan 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.3 years ago

Interventions

Mass testing using RDTsother

To determined the prevalence of asymptomatic malaria parasitaemia. In arm 1 all participants will be tested six times over the study period while in arm 2 the participants will be only be tested at baseline and evaluation.

Treatment for all cases confirmed positive malaria cases with ACTsdrug

During each mass testing, all confirmed positive cases are treated in both arms.

Determination of Hbother

Hb of all children in the subgroup study are measured using a haemocure photometer.

Household surveyother

Determine the prevalence of febrile illnesses among children in the subgroup study

Community-base management of malariaother

Between interventions, participant who become febrile are tested and treated if confirmed positive for malaria by CHWs