Condition category
Infections and Infestations
Date applied
09/01/2017
Date assigned
27/02/2017
Last edited
27/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Malaria is a tropical infection that is spread through mosquitoes. Malaria can be very serious and even fatal as it only takes one mosquito bite to become infected. The symptoms include fever (a high temperature), sweats and chills, vomiting, pain, diarrhoea and headache. Malaria can be prevented and treated by taking antimalarial medication. Cambodia has a very high rate of malaria and therefore has increased the number of Village Malaria Workers (VMWs; community based workers trained to provide treatment for malaria). Despite this, the rates of malaria have still remained high Pregnant women in Cambodia are very vulnerable to malaria and they rarely get in depth care throughout their pregnancy, during birth, and after delivery. Combining both malaria treatments and maternal, neonatal, and child health (MNCH) services could help lower malaria rates and improve the health of women and babies, improving health systems in Cambodia. The aim of this study is to see if combining malaria control and MNCH services can improve the healthcare of women in Cambodia and reduce malaria rates.

Who can participate?
Women who are between the ages of 18 and 29 that are pregnant or have children under the age of two years old living in the participating villages.

What does the study involve?
Participating villages are allocated to one of two groups. Those in the first group receive the integrated continuum of care (ICoC) program through Village Malaria Workers (VMWs) that includes regular health check-ups, health education, and being set up on a system that guides and tracks patients. The second group receive care from VMWs and then are enrolled in the same ICoC program of the first group if there is a positive impact. Two years after the program, follow up is done by randomly surveying participants to ask about their health behaviours and knowledge of maternal health.

What are the possible benefits and risks of participating?
Participants may benefit from increased knowledge about malaria and maternal health. Health centers will have and VMW will benefit from receiving new equipment that will help them diagnose and treat malaria. There are no direct risks of participating.

Where is the study run from?
This trial is run from the University of Tokyo (Japan) and takes place in six health centers in the Ratanakiri province (Cambodia)

When is the study starting and how long is it expected to run for?
April 2015 to March 2020

Who is funding the study?
Japanese Society for the Promotion of Science (Japan)

Who is the main contact?
Dr Junko Yasuoka

Trial website

Contact information

Type

Scientific

Primary contact

Dr Junko Yasuoka

ORCID ID

Contact details

Department of Community and Global Health
The University of Tokyo
7-3-1 Hongo
Bunkyo-ku
Tokyo
113-0033
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Integration of malaria control activities and Maternal, Neonatal, and Child Health services to achieve malaria elimination and better maternal and child health

Acronym

MNCH

Study hypothesis

Integration of malaria control and MNCH services through village malaria workers (VMWs’) network can promote active case detection and treatment of malaria for pregnant women and improve MNCH Integrated Continuum of Care (ICoC).

Ethics approval

1. Research Ethics Committee of the Graduate School of Medicine The University of Tokyo, 11/30/2015, ref: 11030
2. National Ethical Committee for Health Research Cambodia, 10/31/2016, ref: 368NECHR

Study design

Non-randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Malaria and Maternal, Neonatal, and Child Health

Intervention

Participants are allocated into two study arms: the intervention arm and the control arm. Out of 62 Village Malaria Worker villages under six health centers, which are accessible throughout the year in Ratanakiri province, 30 villages under three health centers will be selected by convenience sampling.

The intervention arm involves 30 villages with Village Malaria Workers (VMWs) in Ratanakiri and will include the following:
1. Integrated Continuum of Care (ICoC) orientation
2. ICoC card utilization
3. Regular malaria test and health check-ups
4. Health education

The control arm involves 32 VMW villages and they receive standard care.

After two years from the initiation of the intervention, follow-up survey (face-to-face interviews using structured questionnaire) will be conducted, targeting
- Participants of the intervention in intervention villages
- Randomly selected mothers with children under two in control villages
The follow-up survey will ask about mothers' knowledge and health behavior during and after pregnancy.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Percentage of pregnant women who receive malaria test measured using the Rapid Diagnostic Test four times during pregnancy (about 4 months, 6-7 months, 8 months, and 9 months)
2. Percentage of mothers, who receive all three maternal, neonatal, and child health (MHCH) services (antenatal care, delivery and postnatal care) or Village Malaria Workers’ health check-up four times during pregnancy and after delivery is measured using the integrated continuum care (ICoC) card and is done four times during antenatal care (about 4 months, 6-7 months, 8 months, and 9 months), at delivery, and three times for postnatal care (by 2 days, at 7 days, and at 6 weeks)

Secondary outcome measures

1. Pregnant women’s and mothers’ knowledge about danger signs, breastfeeding, and proper feeding practices for children under two is measured using face to face interviews using structured questionnaires at the end of the intervention
2. Rate of infectious diseases, including malaria, diarrhea, and pneumonia, among mothers and children under two is measured using records in the ICoC at the end of the intervention

Overall trial start date

01/04/2015

Overall trial end date

31/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Intervention arm:
1. Pregnant women
1.2. Between the ages of 18 and 49 years old (reproductive age)
2. Mothers with children under two

Control arm:
1. Pregnant women
1.2. Between the ages 18 and 49 years old (reproductive age)
2. Mothers with children under two

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Refused participating with the intervention
2. Decline to be interviewed

Recruitment start date

01/03/2017

Recruitment end date

01/03/2019

Locations

Countries of recruitment

Cambodia

Trial participating centre

The University of Tokyo, Japan (lead centre) and six
7-3-1 Hongo Bunkyo-ku
Tokyo
113-0033
Japan

Trial participating centre

National Center for Parasitology, Entomology and Malaria Control Cambodia
Corner street 92 Trapaing Svay Village Sankat Phnom Penh Thmey Khan Sensok
Phnom Penh
N\A
Cambodia

Trial participating centre

Kyushu University
Institute of Decision Science for a Sustainable Society Motooka Nishi Ward Fukuoka prefecture
Fukoka
819-0385
Japan

Sponsor information

Organisation

Japanese Society for the Promotion of Science (Grant-in-Aid for Scientific Research)

Sponsor details

Kojimachi Business Center Building
5-3-1 Kojimachi
Chiyoda-ku
Tokyo
102-0083
Japan

Sponsor type

Research council

Website

Funders

Funder type

Research organisation

Funder name

Japanese Society for the Promotion of Science (Grant-in-Aid for Scientific Research)

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 plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

29/02/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes