Objective 1. Identify the barriers and information imbalancesthat reduce childhood immunisation, in particular increasing understanding of the household cost-benefit equations underlying uptake of immunisation
Randomised controlled cluster trials are fairly widely used in developed countries, and have been introduced in several developing countries[18–20].
From the latest Pakistan census, 32 enumeration areas were randomly selected to represent the population of Lasbela district. Once the baseline survey was completed, clusters were randomised into intervention and control, with precautions about the usual biases of this design. In each cluster, interviewers contacted homes of 100 children under the age of 24 months of age (a total of 3344 households). Three successive cycles that examine successive cohorts of children in this age group, and the same number of households in each site (not necessarily the same households) will preserve the proportional representation.
Design of survey instruments
Questionnaires were adapted from international EPI standards. Additional fact-finding tools will produce qualitative evidence – key informant interviews, service worker questionnaires, protocols for institutional reviews and focus group discussions. The results of each round might identify additional stakeholder-driven issues and priorities and be used to refocus the subsequent survey cycles.
In addition to baseline data about the coverage with and obstacles to immunisation, we enriched the standard KAP approach with a behaviour change model adapted by CIET to measure youth responses to risk. The beyond-KAP approach, "cascada", refers to conscious knowledge about immunisation and its side effects, attitudes to childhood immunisation, social norms (what neighbours do) and positive or negative deviation from those norms, intentions to change or to vaccinate in the future, agency (expectancy of self-efficacy or collective efficacy) and discussion about immunisation, its benefits and side effects. The outcome of this "cascada" is the action, immunisation. We will document perceived and real costs of immunisation and non-immunisation, and the household weigh up of costs and benefits.
Eight rounds of piloting in non-sample sites included testing new sections of the instrument, testing the instrument for flow, and then testing the instrument as a whole in order to finalise the process. The pilot exercises assisted in refining the instruments, testing for clarity and ensuring proper translation.
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.
Objective 2. Formulate and implement knowledge transfer based on household cost-benefit equations, compared with health information in reference (control) communities
We will update and translate available knowledge on immunisation and combine this with data from the baseline as an intervention focussed on the household cost-benefit equation. Mass media channels can increase awareness and knowledge, but interpersonal channels seem to work better in changing attitudes and behaviour[23, 24]. A combination of communication channels could, therefore, include mass media appeals, reminder systems and engagement through trusted sources, and addressing risks and benefits of vaccination in an understandable manner[25–28]. Upon consideration of the evidence, people will hopefully adjust their household cost-benefit equations. We will measure this adjustment in the subsequent cycles.
We will estimate the impact of this knowledge transfer on changing beliefs and practices of decision-makers for children and, as a consequence, immunisation uptake. Differences between intervention and reference sites will be analysed for independence from age, sex, household employment, community size, remoteness and other factors. Risk analysis will rely on the Mantel-Haenszel procedure and contrasts reported as the odds ratio (OR) or risk difference (RD)[29–31]. In the analysis, each site or cluster is treated as a mini-universe characterised by certain social dynamics, history, culture and collective practices. Because qualitative data are coterminous (they coincide with the same population) with the individual questionnaires it is easy to link quantitative and qualitative data. An unconditional logistic regression model will be developed where appropriate, using a step-down approach from a saturated model.
We also seek to express a planning-appropriate perspective that fits the household cost-benefit perspective. 'Gain' is the theoretical proportion of the entire population that stands to benefit from the removal of an obstacle or the universalisation of an intervention. It is calculated by multiplying the risk difference (risk among exposed minus risk among unexposed) by the proportion requiring intervention (those exposed, if the interest is to remove risk factors).
Objective 3. Measure the impact of the KT on coverage and attitudes about immunisation
Focus groups to identify strategies
After the preliminary analysis, field teams will return to the communities to hold gender stratified focus groups. Key findings from the household interviews will be shared with the groups to generate additional insights, including how best to let similar communities know about the findings. Focus groups typically involve 8–12 participants. In a quiet location, groups are limited to a maximum of one hour in recognition of the value of participants' time. Participants are reassured about confidentiality (no identifiers are recorded). A trained facilitator runs the group, prompts to provoke discussion, and encourages participants to express opinions. A second member of the team records the content and manages the time.
Communication strategies (see below) to share the outcomes of the measurement with stakeholders in the intervention communities will be heavily conditioned by the outcome of the focus groups. The core concept is to socialise the household cost-benefit equation. Strategies are likely to include work with local elected representatives, community and religious leaders, service workers and community action groups such as citizen community boards (CCBs).
Each year for three years, the measurement will be repeated in both intervention and control sites. Much of the key instrument content will be unchanged, to detect time trends. Responses will provide substrate for the next round of household cost-benefit equations and cost-gain analysis, which in turn will feed into the next round of intervention.
Objective 4. Develop an evidence-based and gendered systems approach to increasing equity in immunisation, rooted in community knowledge, capable of building on local health protection cultures and of informing evidence-based decision-making to improve the health of populations and strengthen health systems through immunisation services
A lot of effort has gone into the supply side of immunisation (vaccine purchase, training health workers and logistics). There is a need to focus systematically on the demand for immunisation – which is probably a direct function of the quality of information people have.
Parallel to the community-based knowledge transfer 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 key public services.
The cost-gains approach offers a bridge between planner and community views. Proving the value of this parameter could support a paradigm shift in resource allocation, from a system based on reconciliation of competing sectoral claims without a comparable evidence base to cost-gain planning.
The main selling point of a new knowledge transfer approach to sustainable immunisation is that it must work. immunisation coverage must increase measurably and people in key positions must know about this. Mainstreaming the household cost-benefit equation begins with respectful dialogue with local health and political authorities about immunisation concepts, service delivery, effects and side effects in the communities. The central activity is then to demonstrate by measuring and communicating, in reiterative cycles, the effect on cost and benefit assessments. Comparisons between sites with different levels or types of intervention will be almost as informative as the longitudinal picture emerging by following each site over four years. Evaluation is thus built into the project.
In addition to the overall concept of evidence-based immunisation support, and the household cost-benefit equation, relevant procedures and tools include:
1. Protocols for the survey (household beyond-KAP, key informants and institutional review) and sample selection, processing results through double data entry, epidemiological analysis and interpretation in community-based focus groups;
2. Procedures for achieving policy level buy-in, including aggregation tools (like customised epidemiological mapping freeware) that allow compounding of local experiences into regional and national pictures; a menu of methods and practical examples of communication tools for opening evidence-based dialogue that can increase community ownership of immunisation.