Impact of Scaling up Mass Testing, Treatment and Tracking on Malaria Prevalence Among Children

NCT04167566 | Completed DMC

• 1 other identifier: NoguchiMIMR
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria; Malaria, Asymptomatic Parasitaemia

Keywords

Impact; mass testing; treatment; tracking; Malaria prevalence; Children; Pakro Ghana

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  Once every 4 months, over a period of 24 months

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

  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.

  24 months

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

  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.

  24 months

Secondary Outcomes (1)

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

  24 Months

Study Arms (1)

Intervention Communities

OTHER

All participants confirmed using rapid diagnostic test (RDTs) to be carrying the malaria parasite will be treated using artemisinin combination therapy (ACT) following the Ghana National Malaria Treatment Guidelines and followed up on days 1, 2, 3 during treatment as DOTs (Directly observed therapy) and on day 7 post treatment. The research team together with Community volunteers will be provided the treatment guidelines which specify the dosage for each treatment regimen. Participants who receive the treatment will be observed for five minutes to ensure that they retain the drug. Those who vomit within this period will have the treatment repeated.

Combination Product: Artemisinin Combination Therapy ACTs

Interventions

Artemisinin Combination Therapy ACTs COMBINATION_PRODUCT

All participants will be tested using RDTs and all confirmed cases will be treated with ACTs. The ACT regimen use at each time will be the one the National Malaria Control Programme will be using at that particular moment.

Intervention Communities

Eligibility Criteria

• Age: 2 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Noguchi Memorial Institute for Medical Research: lead
• World Health Organization: collaborator

Study Sites (1)

Noguchi Memorial Institute for Medical Research

Accra, Greater, +233, Ghana

Location

Related Publications (29)

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• 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.

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• ISRAEL, G. D. 1992. Determining sample size, University of Florida Cooperative Extension Service, Institute of Food and Agriculture Sciences, EDIS.

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• GHANA STATISITCAL SERVICE, 2010. Population and Housing Sensus. District Analytic Report: Akwapim South District.

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• Ndong IC, Okyere D, Enos JY, Amambua-Ngwa A, Merle CSC, Nyarko A, Koram KA, Ahorlu CS. Challenges and perceptions of implementing mass testing, treatment and tracking in malaria control: a qualitative study in Pakro sub-district of Ghana. BMC Public Health. 2019 Jun 6;19(1):695. doi: 10.1186/s12889-019-7037-1.

  PMID: 31170964 RESULT

• Ndong IC, Okyere D, Enos JY, Mensah BA, Nyarko A, Abuaku B, Amambua-Ngwa A, Merle CSC, Koram KA, Ahorlu CS. Prevalence of asymptomatic malaria parasitaemia following mass testing and treatment in Pakro sub-district of Ghana. BMC Public Health. 2019 Dec 3;19(1):1622. doi: 10.1186/s12889-019-7986-4.

  PMID: 31795981 DERIVED

MeSH Terms

Conditions

Malaria; Tooth, Impacted

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ignatius C Ndong, PhD

  Noguchi Memorial Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The interventions are designed to compare the baseline to evaluation findings. There are two components to this implementation study a) The longitudinal (cohort) study: This is basically the prevalence surveys to be conducted with the selected cohort of children 6 months to 15 years - at baseline and before each of the subsequent MTTT rounds. b) The Survey involves using structured questionnaire to interview caretakers of children under five to solicit their views on the implementation process perceived benefits and challenges etc. Though the target group is children from 6 months to 15 years of age, all parasitised adults will be cleared of the parasite during the interventions as well to reduce the parasite reservoirs. Prevalence of malaria trends in cohort group over the study period will reveal the effect of MTTT scale-up on the children 6 month to 15 years. Between interventions, the teams will conduct homes-based management of malaria for confirmed febrile cases.

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 19, 2019
• Study Start: July 1, 2017
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 2017-2019
• Access Criteria: The findings of this study will be published in open access journal and the data will be made available to individual researchers upon request.

Locations

GH (1)