Condition category
Not Applicable
Date applied
15/05/2015
Date assigned
16/06/2015
Last edited
24/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Although there has been a decrease in mortality (deaths) of children under 5, there were still 44 such deaths for every 1,000 live birth around the world reported in 2013. Around 800 women worldwide die every day from pregnancy and childbirth related causes. In 2013, the under-5 children mortality rate in Ghana was 71.4 (per 1,000 live birth), which is higher than the global average. Furthermore, 2,143 women in Ghana died in pregnancy in 1990 and 2,343 were reported dead in 2013. Malaria is a significant cause of death among both children under 5 and pregnant women. Diarrhoea is also a major cause of death among children under 5 in Ghana. A number of previous studies have reported the effect of community-based health care on maternal and child health and a Community-based Health Planning and Services (CHPS) in Ghana was thoroughly designed and applied nationally to respond to the significant shortage of health workers and to improve maternal and child health. The experimental phase of CHPS introduction manifested the effect of engaging volunteer in the system, but emphasis and support on community health volunteers (CHV) in CHPS implementation has been diminished. Recently, the importance of the CHV role in CHPS is being re-emphasized and brought into the political discussion. We expect that it is a timely and significant work to provide scientific evident to support the effect of CHVs on the promotion of health in Ghana. Here, we want to examine the effect of using CHVs in the communities on maternal and child health, through experimental research. Main outcomes of the study are improvement of contraception, maternal health and child health through prevention and treatment services focused on malaria and diarrhoea.

Who can participate?
Households with a woman aged 15-49 with at least one live birth in the past 5 years, a child under 5, and living in 42 communities of Ketu South district, Volta region in Ghana.

What does the study involve?
Communities under 9 CHPS zones are randomly selected and allocated into either the treatment or control group. In the intervention group, CHVs are given proper training, material support, incentives and regular monitoring. They are trained to promote contraception, ante-natal and post-natal care, prevention of diarrhoea in children under 5 through hand-washing and latrine management and prevention of malaria through appropriate use of mosquito net both in children under 5 and pregnant women. CHVs also provide oral dehydration solutions (ORS) for children under 5 experiencing diarrhoea and rapid diagnostic test for malaria to those experiencing suspected fever. Accordingly, the use of CHVs are expected to promote health-related awareness and ultimately encourage healthy behaviours.

What are the possible benefits and risks of participating?
We expect that the community members, especially women in fertility and children of the intervention group will show improved health outcome. Fertile women will benefit by using proper contraception to avoid unwanted pregnancy and to meet the family planning needs. Pregnant women will have more timely treatment thanks to rapid diagnostic test provided by CHVs in the community. Children under 5 will less likely develop malaria and diarrhoea due to regular health promotion and education as well as get proper management when experiencing symptoms. The same targets in the control group will be also benefit after the first phase of the trial. We expect no risks to participating in the study.

Where is the study run from?
Communities under 9 CHPS zones in Ketu South district, Volta region in Ghana

When is the study starting and how long is it expected to run for?
July 2015 to December 2016

Who is funding the study?
Korea International Cooperation Agency (KOICA)

Who is the main contact?
Mr Gyuhong Lee
ghlee@koica.go.kr

Trial website

Contact information

Type

Public

Primary contact

Mr Gyuhong Lee

ORCID ID

Contact details

825 Daewangpangyo-ro
Sujeong-gu
Seongnam-si
Gyeonggi-do
461-833
Korea
South
+82-31-740-0387
ghlee@koica.go.kr

Type

Scientific

Additional contact

Dr Yeonji Ma

ORCID ID

http://orcid.org/0000-0003-3557-4920

Contact details

#301,1057-3
Namhyeon-dong
Gwanak-gu
Seoul
151-800
Korea
South
+82-10-7628-3569
yeonjima@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of community health volunteer activation on maternal and child health in Volta region, Ghana: a cluster randomized controlled trial

Acronym

Study hypothesis

Community Health Volunteer (CHV) activation promotes maternal and child health.

Ethics approval

Ghana Health Service Ethics Review Committee, 16/07/2015, ref: GHS-ERC 07/01/15

Study design

Phase-in study cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Maternal and child health including family planning, malaria, diarrhoea area

Intervention

Activation of CHV is the main intervention of the trial and the intervention will be applied to the intervention group for a year from August 2015 to July 2016 and to the communities under control group for 5 months after completion of intervention to the treatment group.
42 communities were randomly selected from 61 communities under 9 Community-based Health Planning and Services (CHPS) compounds in the study area. They will be allocated to each treatment and control group with restricted randomization method.

We expect CHVs to be activated through provision of training, appropriate equipment for activity, incentives and regular monitoring. Main tasks of CHVs will be home visits to assigned households, support to community health nurse (CHN) activity in the community and outreach program, participation in the monthly review meeting at CHPS with CHNs and other CHVs, regular reporting and surveillance. Home-based counselling and care through home visit is a key activity of CHVs. They will deliver key messages to promote health-related perception and behavior, and deliver preventive and curative services to improve specific health outcomes. Key messages that will be delivered by CHVs include promotion of injectable and implant for contraception, delivery by a skilled birth attendant, utilization of mosquito net, proper hand-washing at 4 critical points, management of latrine and constant check on child's growth. Preventive and curatives measures that CHVs are allowed to take are provision of ORS to the under-5 children experiencing diarrhoea and examination of fever with thermometer and malaria with rapid diagnostic test.
Initial training for CHVs will be consist of 5 day program with theoretical and field training. Further refresher training is planned to strengthen the capacity of CHVs. In order to support activities of CHVs, necessary tools and material incentives will be provided. Equipment list includes rain coat, ID card, logbook, notepad, digital thermometer, educational materials and others. Incentives are composed of phone credit to facilitate theirs communication with the mothers and CHNs and some food items.
CHVs are encouraged to participate in the monthly review meeting held by CHNs at CHPS to report and share the progress and challenges.

Process evaluation will be carried out throughout the study period to monitor and assess implementation of the interventions by household survey, key documentation review and observation. Four times of household survey is planned and review of key documentations such as CHV logbook, community registry, CHPS inventory log and meeting minutes will be conducted mainly at monthly review meeting. Direct observation will be accompanied with household survey and document review process.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Use of contraceptive methods (implant or injectable) in the last 6 months (%)
2. Percentage of pregnant women taking ante-natal care of pregnant women (1 time & 4 or more times)
3. Percentage of women taking post-natal care (within 48 hours & within 6 weeks after delivery)
4. Percentage of pregnant women with fever taking rapid diagnostic test for malaria
5. Percentage of under-5 children with fever taking rapid diagnostic test for malaria
6. Percentage of under-5 children with diarrhoea taking oral dehydration solutions (ORS)
7. Incidence of malaria in under-5 children in the last 2 weeks
8. Incidence of diarrhoea in under-5 children in the last 2 weeks

Measurement methods:
Indicators to measure achievement of the primary outcomes will be assessed through 3 times of household survey; April 2015, February 2016, August 2016. Baseline survey was conducted in April 2015 and midterm survey in February 2016. An endline survey in August 2016 will be carried out after the initiation of intervention in July 2015.

Secondary outcome measures

1. Perceptional and behavioral change in hand-washing at 4 critical points
2. Perceptional and behavioral change in management of latrine
3. Perceptional and behavioral change in utilization of mosquito net
4. Perceptional change in use of contraception methods
5. Perceptional change in diarrheoa treatment using ORS
6. Perceptional change in malaria diagnosis using RDT
7. Perceptional change in taking ANC/PNC
8. Perceptional change in delivering by SBA

Measurement methods:
Indicators to measure achievement of the secondary outcomes including those key ones will be assess through 4 times of household survey accompanying some direct observations; November 2015, February 2016, May 2016, August 2016. Survey in February and August 2016 will be embedded to the midterm and endline survey to measure primary outcomes. Baseline survey conducted in April 2015 will provide the baseline data to measure the change.

Overall trial start date

01/07/2015

Overall trial end date

30/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 15-49 with a at least 1 live birth in the past 5 years and children under 5 years

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

2000 households (2000 mothers and 2000 under-5 children)

Participant exclusion criteria

1. Households without a woman aged 15-49 with at least 1 live birth in the past 5 years
2. Households rejecting participation of the study

Recruitment start date

18/04/2015

Recruitment end date

31/08/2016

Locations

Countries of recruitment

Ghana

Trial participating centre

Korea International Cooperation Agency (KOICA)
825 Daewangpangyo-ro Sujeong-gu Seongnam-si
Gyeonggi-do
461-833
Korea, South

Trial participating centre

Volta Regional Health Directorate, Ghana Health Service
Volta regional health directorate Ho
Volta region
-
Ghana

Sponsor information

Organisation

Korea International Cooperation Agency (KOICA)

Sponsor details

825 Daewangpangyo-ro
Sujeong-gu
Seongnam-si
Gyeonggi-do
461-833
Korea
South
+82-31-740-0114
webmaster@koica.go.kr

Sponsor type

Government

Website

http://koica.go.kr/

Funders

Funder type

Government

Funder name

Korea International Cooperation Agency

Alternative name(s)

KOICA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Korea, South

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.