Plain English Summary
Background and study aims
Malaria remains a major public health problem in the world, although significant progress has been made in recent decades. In the World Health Organization African Region countries, more than 40% of malaria-attributed deaths occur in the Democratic Republic of Congo (DRC) and Nigeria. There is a huge gap between possession and effective use of insecticide-treated bed nets (ITNs) in DRC. The difference between possession and use of ITNs and the risk of household loss can be corrected by using the “door to door” strategy combined with the "hang up" method, which is done by installing ITNs on the beneficiaries’ beds. We aim to investigate the effect of the door to door distribution strategy of ITNs combined with the "hang up" method in the context of mass ITNs distribution campaigns in DR Congo.
Who can participate?
Children aged under 5, pregnant mothers or family members of either of these, living in the Maniema province
What does the study involve?
Participants will be randomly allocated to either the intervention or the control group. Households in the intervention group will receive insecticide-treated bed nets, delivered to their door and hung up outside their house. Households in the control group will be given a token and informed of a specific place within their community where they can collect a net from.
What are the possible benefits and risks of participating?
The possible benefit to participants taking part is that they could be protected from malaria. There are no known risks to participants taking part in this study.
Where is the study run from?
School of Public Health, Kinshasa University (Democratic Republic of Congo)
When is the study starting and how long is it expected to run for?
March 2013 to December 2018
Who is funding the study?
The Episcopal Church Center (USA)
Who is the main contact?
Professor Yan Jin
jinyan1024@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Yan Jin
ORCID ID
http://orcid.org/0000-0002-6118-2069
Contact details
Department of Microbiology
Dongguk University College of Medicine
Dongdae-Ro 123
Gyounju
38066
Korea
South
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NMPC112015
Study information
Scientific title
Effect of long lasting insecticide-treated nets distribution with door-to-door delivery strategy combined with hang-up method on the utilisation of nets in the Maniema province, Democratic Republic of Congo
Acronym
Study hypothesis
We expect that the long lasting insecticide treated nets (LLINs) utilisation rate will be significantly higher among those who received the door-to-door distribution of nets combined with hang-up methods.
Ethics approval
Kinshasa University, 09/09/2013, ESP/CE/071/13
Study design
Interventional single-centre repeated cross-sectional experimental cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Health behaviours, attitude, and knowledge about malaria prevention, particularly mosquito net utilisation
Intervention
Health areas will be randomly allocated into either the intervention or the control group in a 1:1 ratio using a computer-generated block randomisation list. In intervention communities, all households receive one visit by members of the village health team. The team deliver ilong lasting insecticide treated bed nets (LLINs) to every household, door-to-door. The nets will be hung-up inside their house. In control communities, the village health team notify the community of the availability of LLINs from one place in the community, and provide them with tokens. LLINs are then distributed to those who visit this specific place.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Under 5 children’s utilisation of the LLINs during the previous night, assessed by a cross-sectional household survey at the baseline and 12 months after the distribution of LLINs
For the evaluation of the interventions, two cross-sectional household surveys were carried out. The baseline survey was done before the mass distribution in 2013. The end-line survey was conducted 12 months after the distribution of mosquito nets in 2015. The primary outcome is the utilization of insecticide-treated mosquito nets of under-five children at the time of the survey. The measurement was done through direct observation.
Secondary outcome measures
The following are assessed by a cross-sectional household survey at the baseline and 12 months after the distribution of LLINs:
1. Pregnant women’s utilisation of the LLINs during the previous night
2. Family member’s utilisation of the LLINs during the previous night
Overall trial start date
20/03/2013
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Anyone who fits any of the following criteria may participate in this study:
1. Children aged under 5
2. Pregnant mothers
3. Family members of the above
Participant type
All
Age group
All
Gender
Both
Target number of participants
2100 households
Participant exclusion criteria
N/A
Recruitment start date
20/09/2013
Recruitment end date
30/08/2015
Locations
Countries of recruitment
Congo, Democratic Republic
Trial participating centre
School of Public Health, Kinshasa University
Avenue de l'Université
Kinshasa
BP 127 Kinshasa XI
Congo, Democratic Republic
Sponsor information
Organisation
Dongguk University
Sponsor details
Department of Microbiology
Dongguk University College of Medicine
Gyeongju
Korea. 123
Dongdae-Ro
Gyeongju-si
Gyeongsangbuk-do
Korea
Gyeongju-si
38066
Korea
South
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
The Episcopal Church Center
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available.
Intention to publish date
01/12/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list