Improving immunisation timeliness in infants and young children

A pragmatic, multi-centre, parallel design (1:1:1), open, randomised controlled trial to evaluate the effectiveness of a simple short message service (sms) vs tailored sms and home visiting compared to usual parent/carer practice to improve the uptake and timeliness of the primary immunisation series in children aged less than 2 years

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000204448

Acronym

PRICKLE BABES STUDY

Enrollment

322

Registered

2016-02-16

Start date

2016-06-02

Completion date

2018-06-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The uptake and timeliness of the primary immunisation series in infancy is critical to preventing infectious diseases morbidity and mortality. There is a high burden of vaccine preventable diseases in Aboriginal and Torres Strait Islander children irrespective of geographic location, however limited attention has been paid to those living in urban and regional settings. The need to improve the timeliness of the primary series has been known for at least 10 years but there has been little change over that time. Recent data from a cohort of Aboriginal and Torres Strait Islander children in Caboolture, Queensland suggests approximately 44% of children have not completed the primary series by 7 months of age. Identifying simple, culturally appropriate and cost effective interventions to improve timeliness is therefore a priority. This trial aims to To evaluate the effectiveness of targeted, culturally appropriate short messaging service (SMS) and/or home visiting in improving the uptake and timeliness of the primary immunisation series in urban/regional Aboriginal and Torres Strait Islander children

Interventions

Intervention Group A: a simple reminder sms will be sent once a fortnight starting 2 weeks before until 2 weeks following each milestone due date at 8, 16 and 24 weeks of age. All children not up to date at the 28-week timepoint will have a home visit to complete the primary series. Intervention Group B: a tailored sms with an educational message will be sent 2 weeks before and the week of the milestone due date. Children not immunised by 2 weeks following the due date will receive a home visit. Tailoring of the message will include a personal reference reference to the parent and child, his/her vaccines due, why it is important to get the vaccines and to be on time (educational component) and information on who to contact to schedule an appoinment. Information about access to transport services will also be provided. Adherence in both arms will be monitored by recording receipt and opening of sms messages and recording whether a response to the text message was received (response received yes or no).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

12 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

(i) Mother in the 2nd or 3rd trimester of pregnancy (ii) Not planning to move from the study area until the infant turns 8 months of age (iii) Access to a mobile phone (iv) Provision of written informed consent from the mother (v) Caboolture Community Medical l or Carbal are the family’s usual health care provider. (vii) For the RCT component, a live born infant

Exclusion criteria

None will apply

Outcome results