Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

5,861

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

March 1, 2020

Completed

3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed

Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

March 4, 2020

Last Update Submit

May 3, 2023

Conditions

Malaria Asymptomatic Parasitaemia

Keywords

MalariaDetermineimpactmass testing and treatmentchildren under 5Pakro Ghana

Outcome Measures

Primary Outcomes (1)

The effect of MTTT/home-base management of malaria on malaria prevalence in children
The difference in asymptomatic malaria parasitaemia prevalence in children \<15 years in the intervention arm compared to the control arm.
2 years

Secondary Outcomes (5)

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

Study Arms (2)

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

Other: Mass testing using RDTsDrug: Treatment for all cases confirmed positive malaria cases with ACTsOther: Determination of HbOther: Household surveyOther: Community-base management of malaria

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.

Other: Mass testing using RDTsDrug: Treatment for all cases confirmed positive malaria cases with ACTsOther: Determination of HbOther: Household surveyOther: Community-base management of malaria

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.