TITLE: Effects of engaging communities in decision making and action through traditional and religious leaders on fully vaccination rates; a cluster randomized control trial.1. Background

Low vaccination rates continue to be a problem, especially for vulnerable and marginalised populations in the midst of weak routine vaccination services. There is need for interventions to increase uptake in a sustainable and cost-effective manner. Traditional and religious leaders are influential and are respected in their communities as opinion formers and guides in religious, social and family life. They have been used to support mass campaigns for vaccination activities and as agents of change to get communities to use health services. National immunisation programs have adopted this strategy as part of their mandate for Polio Eradication. However, most interventions are focused on the provision of information, which is useful, but fall short to really empowering communities to act.
This intervention aims at evaluating the use of the traditional and religious leaders (TRL) as a means to engage communities in the planning, implementation, and monitoring of immunisation services in selected communities in Cross River State, Southern Nigeria.

2. Objectives and Aims
The primary objective of the trial is:
• to evaluate the effects of a community- and health facility-based multi-component intervention on vaccination coverage in children 0-23 months old.
The secondary objectives of the trial are to:
• evaluate the impact on the proportion of children 0-23 months old starting but not completing the course of Pentavalent 1-3 vaccinations
• evaluate the impact on the timing of Pentavalent and measles vaccinations
• evaluate the impact on the morbidity and mortality to vaccine-preventable diseases
• evaluate the changes in the processes and perceptions of actors
• estimate the costs and cost-effectiveness of the intervention
• evaluate the impact on utilization of other preventive clinic services

3. Methods / Approaches
This is a prospective cluster-randomised controlled trial. The intervention has multiple components targeting:
• TRL: Continuous education programmes
• Communities: meetings with WDC to exchange ideas, organization of utilisation of services
• Health services: quality of care, feedback on vaccination status
• Ward Development Committees (WDC): strengthening decision-making and monitoring

The study is sited in Cross River State, South-South geopolitical zone of Nigeria. The State has 18 Local Government Areas and 193 political wards. There are 18 Local Government Areas (LGAs) in the study location. Eight LGAs are selected from the north, central and south of the State. The eight LGAs are selected, in four strata. The strata are: north urban, central rural, south rural, mixed urban. Two LGAs are randomly selected per strata and one of each pair is randomised to control or intervention. Three wards are selected within each LGA using simple random sampling using R. Each ward has between 2 and 16 villages, within the region of 500-2000 inhabitants. Wards adjacent to a ward in the opposite study arm are not eligible for selection. Within each ward, four villages are randomly selected. Where there are less than four villages in a ward all the villages are included in the study. Within each village, 25 children aged 0-23 months are selected.
The total sample size for the baseline survey is 1200 children per study arm. Details of the sample size calculation are available in the pre-analysis plan. The sample size was calculated on the basis that 53% of children would be fully vaccinated in the absence of the intervention: from the tables below this number is reasonable. The sample size is based on the desired 10% change from 53% assumed pre-intervention proportion of fully vaccinated children with at least 80% power and a 5% significance level.

Baseline data to assess level of vaccine coverage in the study communities was conducted. This involved community survey, Focus Group Discussions (FGDs), and key informant interviews (KIIs) to elicit the causes of low vaccination and the role of the community leaders in routine vaccination.

4. Results

Baseline Results:
The carers of 1301 children in control LGA and 1297 children in intervention LGA were surveyed from 2667 households visited. Vaccination card was seen for 70% of the children. Based on the record from the card 43.4% of the children were up-to-date with their vaccination at the time of the study; 9.8% were unvaccinated. There was delay in children getting vaccinated on schedule.
Factors identified during the FGDs and KIIs as the causes of delay in vaccination or complete resistance to vaccination included fear of side effects and facility oriented factors like poor logistic support, inadequate manpower among others. Below are some quotes from the sessions.
“There is real irony in the belief of our people that immunization makes a child not to walk well. They belief that when they bring their children as healthy as they are that the injection used will further paralyse the child. So instead of taking a healthy child to the centre for immunization I should take the one that is sick” (WDC, Etung).
“Some are afraid of injection, that the injection gives their babies fever” (Caregiver, Abi).
“Most nursing mothers complain about the cry of the baby after bringing the child for immunization.” (WDC, Abi).
“… They see it as something that will bring more harm” (Religious leader, Etung).
The sessions also explored the role the traditional and religious leaders played in routine vaccination. Below were the responses from the respondents:
“It is only during campaigns that we involve a larger group but for the routine immunization every community member knows that every [it is on] Thursday or Wednesday.”(Health worker, Ikom).
“Routine immunization is … normally is for those that are working in the health facility. Our team don’t interfere.”(WDC member Obudu).
“I am not sure we do anything in routine. It is only when they send letters for campaign immunization” (Religious leader, Etung).

5. Target Groups
The intervention targets traditional rulers, religious leaders, Ward Development Committee members, health workers, and the community members. It aims at getting community involved in routine vaccination.

6. Further lines of action / next steps

The interventions are developed around existing structures in the community. Communities are randomised into intervention and control arms using the LGA as the unit of randomization. The control arm receives routine care while the intervention receives the different components of training and community engagement. Eight sessions of training of the leaders are planned within 18 months along with a session of training of health workers. Training sessions with the community leaders target empowering the leaders to improve their knowledge on vaccination and vaccine preventable diseases, and supporting them to assume their leadership role in vaccination. The training for the health workers is to provide them with support tools for problem analysis and production of user-friendly information on their performance to the community. Other interventions are strengthening of the Ward Development Committee and sharing of vaccination information with the community.

7. Other important information
The intervention is on-going.