Malaria Clinical Trial
Official title:
Exploring the Impact of Scaling up Mass Testing, Treatment and Tracking on Malaria Prevalence Among Children in the Pakro Sub District of Ghana
NCT number | NCT04167566 |
Other study ID # | NoguchiMIMR |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | July 30, 2019 |
Verified date | November 2019 |
Source | Noguchi Memorial Institute for Medical Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5000 |
Est. completion date | July 30, 2019 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Months to 15 Years |
Eligibility |
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 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 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). |
Country | Name | City | State |
---|---|---|---|
Ghana | Noguchi Memorial Institute for Medical Research | Accra | Greater |
Lead Sponsor | Collaborator |
---|---|
Noguchi Memorial Institute for Medical Research | World Health Organization |
Ghana,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | The cost benefit analysis of the scaling up MTTT intervention in the area will be known. | This outcome describes the benefit in terms of number of cases of malaria prevented or amount of income saved by the participants or resources saved by the health system as a result of implementing MTTT | 24 Months |
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