Household cost-benefit equations and equity in immunisation: a randomised cluster controlled trial of knowledge translation for sustainable universal childhood immunisation in south Pakistan

ISRCTN	ISRCTN12421731
DOI	https://doi.org/10.1186/ISRCTN12421731
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	T-0581-100-19
Sponsor	International Development Research Centre (Canada)
Funder	International Development Research Centre (Canada)

Submission date: 09/03/2005
Registration date: 18/04/2005
Last edited: 25/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Neil Andersson
Scientific

CIET Canada
1 Stewart Street
Room 319
Ottawa
K1N 5R2
Canada

Phone	+1 613 562 5393
Email	neil@ciet.org

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Household cost-benefit equations and equity in immunisation: a randomised cluster controlled trial of knowledge translation for sustainable universal childhood immunisation in south Pakistan
Study objectives	The hypothesis is that this dynamic equation can be influenced by a multi-directional knowledge transfer (KT) and, based on this culture-appropriate exchange, that people will adjust their household cost-benefit equations and their uptake of immunisation. A corollary of the household cost-benefit equation is accessible to planners and health service managers: cost-gains. By deriving this from the same data used by communities for their cost-benefit equations, a common language can be identified for interaction between health services and communities. Parallel to the community-based knowledge transfer (KT) intervention, the team will work with the district authorities in Lasbela. We will build capacity to improve immunisation rates in the selected district, reaching health care workers, community leaders and policy makers. Research teams will be trained in community-based research, enhancing the capacity for ongoing monitoring of immunisation and other health interventions. This project hopes to address two main areas: 1. In the Lasbela district, what cost-benefit calculations are used to make decisions about immunisation and how do they change over the four year period? 2. Does the intervention-sharing of information in focus groups and the feedback loop- influence the household cost-benefit calculation? If so, how?
Ethics approval(s)	Two review panels, one at the University of Ottawa and a panel in the south of Pakistan registered with the US Government's Office of Human Research Protections, deliberated the ethical issues and approved the study.
Health condition(s) or problem(s) studied	Immunisation
Intervention	We propose to test the importance of this household cost-benefit equation that decision-makers for children derive from their knowledge, attitudes, social norms, intentions, sense of agency and degree of socialisation about immunisation. Step 1: Two communities will be chosen as the locations for piloting the cost-benefit survey. Piloting involves development of the instrument and making changes through collaboration with the communities. Step 2: The communities in which the pilot was performed will be excluded from the randomisation. Step 3: All households in both the intervention and control communities will respond to the household questionnaire. In the case of the intervention communities the information gathered in the household questionnaire will be brought back to the communities in focus groups (one focus group of 6 - 10 people in each of the 10 intervention locations). Step 4: Step 3 will be repeated 3 additional times over the four year period in order to assess any changes in household cost-benefit calculations. The use of a control group permits us to see whether observed changes are the result of the focus group feedback loop or caused by factors external to the project.
Intervention type	Other
Primary outcome measure(s)	Survey content: In addition to baseline data about the coverage with and obstacles to immunisation, the standard Knowledge, Attitudes, and Practices (KAP) approach will be enriched by a modification: steps to behaviour change model developed by Community Information and Epidemiological Technology (CIET) to measure youth responses to risk. CIETs beyond-KAP approach, "cascade", refers to knowledge about: 1. Immunisation and its side effects 2. Attitudes to childhood immunisation 3. Social norms (what neighbours do) and positive or negative deviation from those norms 4. Intentions to vaccinate in the future 5. Agency (self-efficacy expectancy about immunisation) and degree of socialisation or discussion about immunisation, its benefits and side effects The outcome of this "cascade" is immunisation, which will be documented in detail. Attention will be paid to perceived or real costs of immunisation and non-immunisation, and the weigh up costs and benefits. Gender and poverty affect the household cost-benefit equation. The poor, who typically have less access to services and less information about services, will almost certainly weigh up the cost and benefit in a different way than will the rich. Some diseases like measles and pertussis may be an inconvenience for the well nourished but, for the malnourished, they are a question of life or death. Costs of not vaccinating (disease burden, care and funerals) are borne disproportionately by the poor and, in a single epidemic; they can wipe out household economies.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	2000
Total final enrolment	958
Key inclusion criteria	This project is a randomised controlled trial; randomisation will be computer generated. There will be 2000 participating households (1000 intervention; 1000 control); 20 locations are to be chosen and randomised by computer (10 intervention; 10 control) and interviewers will interview 100 households with parents of children less than 5 years or parents planning on having children in the next year in each of these locations.
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/07/2004
Date of final enrolment	31/07/2008

Locations

Countries of recruitment

Canada
Pakistan

Study participating centre

CIET Canada

Ottawa
K1N 5R2
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/10/2009	25/02/2021	Yes	No
Protocol article	protocol	28/06/2005		Yes	No

Editorial Notes

25/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
06/11/2019: Internal review.