Condition category
Not Applicable
Date applied
30/08/2018
Date assigned
18/02/2019
Last edited
22/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

http://med.dongguk.ac.kr/

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

Publication citations

Additional files

Editorial Notes

22/02/2019: Internal review.