Condition category
Infections and Infestations
Date applied
09/03/2005
Date assigned
18/04/2005
Last edited
20/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Andersson

ORCID ID

Contact details

CIET Canada
1 Stewart Street
Room 319
Ottawa
K1N 5R2
Canada
+1 613 562 5393
neil@ciet.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

T-0581-100-19

Study information

Scientific title

Acronym

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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. CIET’s 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.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/07/2004

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/07/2004

Recruitment end date

31/07/2008

Locations

Countries of recruitment

Pakistan

Trial participating centre

CIET Canada
Ottawa
K1N 5R2
Canada

Sponsor information

Organisation

International Development Research Centre (Canada)

Sponsor details

250 Albert Street
Ottawa
K1P 6M1
Canada
+1 613 236 6163
info@idrc.ca

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

International Development Research Centre (Canada)

Alternative name(s)

Centre de recherches pour le développement international, IDRC

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Canada

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

Protocol in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15985160

Publication citations

  1. Protocol

    Andersson N, Cockcroft A, Ansari N, Omer K, Losos J, Ledogar RJ, Tugwell P, Shea B, Household cost-benefit equations and sustainable universal childhood immunisation: a randomised cluster controlled trial in south Pakistan [ISRCTN12421731]., BMC Public Health, 2005, 5, 72, doi: 10.1186/1471-2458-5-72.

Additional files

Editorial Notes