Condition category
Infections and Infestations
Date applied
01/06/2013
Date assigned
07/06/2013
Last edited
10/06/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In partnership with the Division of Disease Surveillance and Response (DDSR) at the Ministry
of Public Health and Sanitation (MOPHS) in Kenya, a study will be conducted to see how well the short message service (SMS)-based outbreak alert system works when compared to the standard practice currently in practice in Kenya. Health facility representatives will use this system to report suspected disease outbreaks for a period of 6 months.

Who can participate?
153 health facilities, that are run by the government, private and non-profit organisations, belonging to 12 districts in Kenya, can participate in this study.

What does the study involve?
The health facilities are randomly allocated to one of two groups. Health facility workers, who is in charge of surveillance, belonging to one group will use the SMS-based disease outbreak alert system and those in the other (control) group will use the standard system. The time spent on disease notification at the health facility, and the response by surveillance coordinators at national and district levels will be measured and compared.

What are the possible benefits and risks of participating?
The results will help to understand and consider the effectiveness of the SMS-based outbreak alert system in order to enhance the disease surveillance and response mechanisms in Kenya.

Where is the study run from?
The study sites will include the two counties, Busia and Kajiado in Kenya.

When is the study starting and how long is it expected to run for?
The study is starting in June 2013 and is expected to run till March 2014.

Who is funding the study?
JICA-JST SATREPS project, Japan and Kenya.

Who is the main contact?
Ms Mitsuru Toda
mitsuru@post.harvard.edu

Trial website

Contact information

Type

Scientific

Primary contact

Ms Mitsuru Toda

ORCID ID

Contact details

KEMRI-NUITM
PO Box 1993-00202
Nairobi
00202
Kenya

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluating the response to suspected disease outbreaks using a short message service (SMS) model: a cluster randomized controlled trial

Acronym

Study hypothesis

To determine the feasibility of the implementation of an SMS based based outbreak alert model and evaluate the timeliness of disease notification and response in selected health facilities in Kenya.
Null hypothesis: Implementation of the SMS based outbreak alert system will not change the timeliness of notification and response of disease outbreaks in selected health facilities in Kenya.

Ethics approval

Kenya Medical Research Institute (KEMRI) Ethical Review Committee (ERC) gave approval on 6th May 2013. [Scientific Steering Committee (SSC) reference number 2523]

Study design

Interventional, single-center, pre-post cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request an interviewee information sheet

Condition

14 priority diseases that require immediate reporting: adverse events following immunization,
anthrax, cholera, Guinea worm, measles, neonatal tetanus, plague, Rift Valley fever, severe
acute respiratory infections, viral hemorrhagic fever, yellow fever, and other (any public health
event of national and international concerns).

Intervention

153 facilities in 12 districts will be randomized to two groups: intervention and control groups, to measure the effects of the SMS-based outbreak alert system before and after implementation.
The intervention will target health facility workers, a representative who is in-charge of surveillance, to utilise the SMS-based outbreak alert system. Surveillance
coordinators at the national and district levels who are in charge of data management and outbreak response will be the ones who will manage, consume, and act upon the information that is sent through the SMS-based outbreak alert system.
Control: The standard disease notification and response systems (mostly paper-based) that are currently in place in Kenya.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Percentage of health facilities that reported suspected outbreak cases within 24 hours to the next level
2. Percentage of health facilities that responded to suspected outbreak cases within 24 hours of notification

Secondary outcome measures

1. To assess the feasibility of implementing the SMS-based outbreak alert system
2. To determine the impact of the SMS-based outbreak alert system on the timeliness of disease outbreak notification
3. To determine the impact of the SMS-based outbreak alert system on the timeliness of disease
outbreak response
4. To determine qualitatively the factors that influence performance on disease outbreak
notification and response
Documents review, structured interview, and knowledge assessment questions will be conducted to collect quantitative information. Key informant interview will be conducted to collect qualitative information.

Overall trial start date

17/06/2013

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Health facilities that are listed on the Kenya Master Facility List (MFL)
2. Health facilities that offer curative services
3. Health facilities that are operational
4. Interviews will be conducted with health workers and disease surveillance coordinators who are literate and can comprehend English

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

153 health facilities

Participant exclusion criteria

1. Health facilities that are not listed on MFL
2. Health facilities that do not offer curative services
3. Health facility in-charges or a representative who cannot send SMS during training
4. Health facilities that do not have mobile phone network coverage in the area

Recruitment start date

17/06/2013

Recruitment end date

31/03/2014

Locations

Countries of recruitment

Kenya

Trial participating centre

KEMRI-NUITM, PO Box 1993-00202
Nairobi
00202
Kenya

Sponsor information

Organisation

Nagasaki University (Japan)

Sponsor details

Institute of Tropical Medicine
1-12-4 Sakamoto
Nagasaki
852-8523
Japan

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

JICA-JST SATREPS project (Partners include: Japan International Cooperation Agency (JICA), Japan Science and Technology Agency (JST), Nagasaki University, Ministry of Public Health and Sanitation in Kenya, and Kenya Medical Research Institute)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes