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Determining the Impact of Scaling up Mass Testing, Treatment and Tracking on Malaria Prevalence in Ghana (DetI-MTTT)

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ClinicalTrials.gov Identifier: NCT04301531
Recruitment Status : Recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
Ghana National Malaria Control Programme
Communities
Information provided by (Responsible Party):
Noguchi Memorial Institute for Medical Research

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.


Condition or disease Intervention/treatment Phase
Malaria Asymptomatic Parasitaemia Other: Mass testing using RDTs Drug: Treatment for all cases confirmed positive malaria cases with ACTs Other: Determination of Hb Other: Household survey Other: Community-base management of malaria Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

In the intervention arm, all participants are tested using RDTs and treated if they carry the malaria parasite. This is carried out six times in two years.

In the control arm participants are only tested and treated if confirmed to be carrying the parasite at baseline and evaluation.

Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Determining the Impact of Scaling up Mass Testing, Treatment and Tracking on Malaria Prevalence Among Children in the Pakro Sub District of Ghana
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Arm 1 (intervention arm)
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 RDTs
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.

Drug: Treatment for all cases confirmed positive malaria cases with ACTs
During each mass testing, all confirmed positive cases are treated in both arms.

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

Other: Household survey
Determine the prevalence of febrile illnesses among children in the subgroup study

Other: Community-base management of malaria
Between interventions, participant who become febrile are tested and treated if confirmed positive for malaria by CHWs

Arm 2 (control arm)
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 RDTs
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.

Drug: Treatment for all cases confirmed positive malaria cases with ACTs
During each mass testing, all confirmed positive cases are treated in both arms.

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

Other: Household survey
Determine the prevalence of febrile illnesses among children in the subgroup study

Other: Community-base management of malaria
Between interventions, participant who become febrile are tested and treated if confirmed positive for malaria by CHWs




Primary Outcome Measures :
  1. The effect of MTTT/home-base management of malaria on malaria prevalence in children [ Time Frame: 2 years ]
    The difference in asymptomatic malaria parasitaemia prevalence in children <15 years in the intervention arm compared to the control arm.


Secondary Outcome Measures :
  1. Prevalence of anaemia in <15 children [ Time Frame: 2 years ]
    The difference in the prevalence of anaemia in children <15 years in the intervention arm compared to the control arm

  2. Prevalence of febrile illnesses [ Time Frame: 2 years ]
    The difference in prevalence of febrile illnesses in children <15 years in the intervention arm compared to the control arm

  3. Prevalence of asymptomatic malaria parasitaemia among household members [ Time Frame: 2 years ]
    The difference in asymptomatic malaria parasitaemia prevalence in household members in the intervention arm compared to the control arm.

  4. Difference in symptomatic malaria cases attending health facilities [ Time Frame: 2 years ]
    The difference in symptomatic malaria cases attending health facilities from households in the intervention arm compared to the control arm.

  5. Cost benefit analaysis of implementing MTTT [ Time Frame: 2 years ]
    The difference in cost benefit of MTTT between arm 1 and arm 2



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Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301531


Contacts
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Contact: Ndong Ignatius Cheng, PhD +233561817573 Ncheng@noguchi.ug.edu.gh
Contact: Collins S Ahorlu, PhD +233240439337 Cahorlu@noguchi.ug.edu.gh

Locations
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Ghana
Noguchi Memorial Institute for Medical Research Recruiting
Accra, Greater, Ghana, +233
Contact: Abraham K Anang, PhD    +2332448335872    Aanang@noguchi.ug.edu.gh   
Contact: Collins s. Ahorlu, PhD    +233240439337    cahorlu@noguchi.ug.edu.gh   
Principal Investigator: Ndong Ignatius Cheng, PhD         
Sponsors and Collaborators
Noguchi Memorial Institute for Medical Research
Ghana National Malaria Control Programme
Communities
Investigators
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Principal Investigator: Ndong Ignatius Cheng, PhD Noguchi Memorial Institute for Medical Research
Publications:
DISTRICT HEALTH DIRECTORATE, 2015. District Annual Report 2015, Akwapim South, Aburi, Ghana
GNMCP 2006. Ghana National Malaria Control Programme: Ghana Health Service Report 2006 Accra.
GHANA STATISITCAL SERVICE, 2010. Population and Housing Sensus. District Analytic Report: Akwapim South District.
ISRAEL, G. D. 1992. Determining sample size, University of Florida Cooperative Extension Service, Institute of Food and Agriculture Sciences, EDIS.
OTUPIRI, E., YAR, D. & HINDIN, J. 2012. Prevalence of Parasitaemia, Anaemia and treatment outcomes of Malaria among School Children in a Rural Community in Ghana. Journal of Science and Technology (Ghana), 32, 1-10.
WORLD HEALTH ORGANISATION Roll Back Malaria Report. Geneva: WHO; 2003. http://www.rollbackmalaria.org/microsites/wmd2011/amr_toc.html. Accessed 15 November. 2016
WORLD HEALTH ORGANISATION. World Malaria Report 2009. Geneva: WHO; 2009 http://www.who.int/malaria/world_malaria_report_2014/en. Accessed 3 December. 2016
WORLD HEALTH ORGANISATION. World Malaria Report 2010. Geneva: WHO; 2010. http://www.who.int/malaria/world_malaria_report_2010/en. Accessed 1 December 2016
WORLD HEALTH ORGANISATION. World Malaria Report 2011. Geneva: WHO; 2013 http://www.who.int/malaria/publications/world_malaria_report_2013/en. Accessed 2 December 2016
WORLD HEALTH ORGANISATION. World Malaria Report 2014. Geneva: WHO; 2014 http://www.who.int/malaria/publications/world_malaria_report_2014/en. Accessed 1 December, 2016

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Responsible Party: Noguchi Memorial Institute for Medical Research
ClinicalTrials.gov Identifier: NCT04301531    
Other Study ID Numbers: NMIMR
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noguchi Memorial Institute for Medical Research:
Malaria
Determine
impact
mass testing and treatment
children under 5
Pakro Ghana
Additional relevant MeSH terms:
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Malaria
Parasitemia
Protozoan Infections
Parasitic Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes