Combining health services for malaria and maternal and child health to improve health of mothers and children in rural communities
| ISRCTN | ISRCTN18422527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18422527 |
| Protocol serial number | N/A |
| Sponsor | Japanese Society for the Promotion of Science (Grant-in-Aid for Scientific Research) |
| Funder | Japanese Society for the Promotion of Science (Grant-in-Aid for Scientific Research) |
- Submission date
- 09/01/2017
- Registration date
- 27/02/2017
- Last edited
- 05/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Department of Community and Global Health
The University of Tokyo
7-3-1 Hongo, Bunkyo-ku
Tokyo
113-0033
Japan
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised controlled trial |
| Secondary study design | Non randomised study |
| Scientific title | Integration of malaria control activities and Maternal, Neonatal, and Child Health services to achieve malaria elimination and better maternal and child health |
| Study acronym | MNCH |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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) |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/03/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 400 |
| Total final enrolment | 696 |
| Key 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 |
| Key exclusion criteria | 1. Refused participating with the intervention 2. Decline to be interviewed |
| Date of first enrolment | 01/03/2017 |
| Date of final enrolment | 01/03/2019 |
Locations
Countries of recruitment
- Cambodia
- Japan
Study participating centres
Bunkyo-ku
Tokyo
113-0033
Japan
Trapaing Svay Village
Sankat Phnom Penh Thmey
Khan Sensok
Phnom Penh
N\A
Cambodia
Motooka
Nishi Ward
Fukuoka prefecture
Fukoka
819-0385
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
04/04/2019: The final enrolment number was added.
