Condition category
Not Applicable
Date applied
16/07/2014
Date assigned
28/08/2014
Last edited
22/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Tetanus, Diphtheria and Pertussis (Whooping Cough) are life-threatening diseases for people of all age groups. Despite this, worldwide, healthcare providers are finding that many people fail to keep their immunization appointments. In Kadoma City, Zimbabwe, a recent review found that only 74% of babies aged 6 weeks, 84% of babies aged 10 weeks and 74% of babies aged 14 weeks were being vaccinated against these diseases. Low vaccination rates can often result in outbreaks of the diseases that the vaccines are meant to prevent and could mean that the progress made towards achieving Millennium Development Goal 4 (MDG 4) (reducing the number of deaths among children under 5 years old by two-thirds) is reversed. It is, therefore, very important to try and encourage more people to vaccinate themselves and their families. This study will find out if using short message services (SMS), otherwise known as text messages, will encourage mothers to bring in their babies for immunization. We are also interested in knowing how much it costs and how many people are willing to be reminded in this way.

Who can participate?
Mothers or caregivers of babies that visit one of a number of Kadoma City Clinics on the third or seventh day after the birth of the child. They also have to have a cell phone.

What does the study involve?
Participants are randomly allocated into one of two groups. For those people in group 1 (intervention group), short message service reminders are sent to each person's cellphone to remind them to bring their children in for their vaccinations at 6, 10 and 14 weeks after birth. The first reminder is sent 7 days before the due immunization date. The second reminder is sent 3 days before and the third, final reminder, is sent a day before the immunization appointment. They are also given routine immunization health education materials. People in group 2 (control group) are only given the routine immunization health education materials. The vaccination rate is then analysed.

What are the possible benefits and risks of participating?
There are no any financial or other material benefits for participants in this study. However, taking part may give them an opportunity to learn and understand more about childhood immunization. The study is not expected to cause any physical harm. Some questions are asked about the participants social life which they may not feel comfortable enough about to answer, but they are free to ignore these questions if they wish.

Where is the study run from?
Kadoma City Clinics namely Rimuka Family Child Health, Ngezi, Waverly, Chemukute and Kadoma General Hospital (Zimbabwe).

When is the study starting and how long is it expected to run for?
January 2013 to August 2013.

Who is funding the study?
MPH Programme, University of Zimbabwe (Zimbabwe).

Who is the main contact?
Bangure Donewell
bangured@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mufuta Tshimanga

ORCID ID

Contact details

University of Zimbabwe
P.O Box A167
Avondale
Harare
00263
Zimbabwe
+263 (0) 775762259
tshimangamufuta@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MRCZ/B/492

Study information

Scientific title

Effectiveness of short message services reminders on a childhood immunization programme in Kadoma, Zimbabwe - a randomized controlled trial, 2013

Acronym

Study hypothesis

There is no difference on the immunization coverage among those receiving short message reminders and routine immunization health education material and those receiving routine immunization health education material only

Ethics approval

1. Joint Parirenyatwa Hospital and College of Health Sciences Research Ethics Committee, 23/04/2013, ref: JREC 31/13
2. The Medical Research Council of Zimbabwe, 06/05/2013, ref: MRCZ/B/492

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

N/A

Condition

Immunization

Intervention

Participants were randomly allocated into two groups.
1. Intervention group: In the intervention group short message service reminders were sent to study participants cellphones reminding them to bring children for immunization. They also recieved routine immunization health education materials
2. Control group: Received only the routine immunization health education materials

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary outcome measure was receipt of scheduled vaccines at 6, 10 and 14 weeks. This was measured by the attendance for each antigen during the three visits at 6, 10 and 14 weeks.

Secondary outcome measures

N/A

Overall trial start date

01/01/2013

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women or caregiver with a cell phone
2. A resident of Kadoma city
3. Consented in writing

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

306

Participant exclusion criteria

1. Mothers or caregivers that did not own a cell phone
2. Not a resident of Kadoma city

Recruitment start date

01/01/2013

Recruitment end date

31/08/2013

Locations

Countries of recruitment

Zimbabwe

Trial participating centre

University of Zimbabwe
Harare
00263
Zimbabwe

Sponsor information

Organisation

University of Zimbabwe (Zimbabwe)

Sponsor details

P.O Box A167
Avondale
Harare
00263
Zimbabwe
+263 (0) 4792157
tshimangamufuta@gmail.com

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Zimbabwe, Department of Community Medicine (Zimbabwe)

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25778170
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25885862

Publication citations

Additional files

Editorial Notes