Study Design, Period and Area
A Community-based unmatched case–control study design was conducted from March 20 to April 30, 2022 in Siraro District. The district is found in the West Arsi Zone and composed of 4 urban and 28 rural kebeles. Kebele is the smallest administrative unit below district according to Ethiopian context. The District is located in South west of Ethiopia at 64 Km far from the capital city of zone Shashemene and 314 Km from capital city of the country Addis Ababa. In line with the national immunization strategies, the district is providing Expanded Program on Immunization services through static and outreach strategies. There are 38 outreach sites which providing immunization services for communities living more than 5 km from the nearest health facility. The District Health Office is directly involved in providing support to primary health care units through conducting supportive supervision and quarterly review meetings.
According to the Siraro District Health Office estimate in 2021/22, the total population in the District is 217,572 with 35,749 under-five children and the estimated children aged 12–23 months are 16,326. The District has 1 Primary Hospital, 7 Health Centers and 27 functional Health Posts regarding Public health facilities’ coverage and there are 139 health professionals and 54 health extension workers (HEWs) in the district (Source: Siraro District Health Office).
Source Population And Study Population
The source and study population were all children aged 12 to 23 months with their mothers/ caretakers who had received at least one dose of the routine vaccination and living in eligible households from randomly selected kebeles in Siraro District. Cases were children between the ages of 12–23 months with their mothers/ caretakers who had missed at least one dose of the recommended routine vaccination for any reason and not full vaccinated for age as per national immunization schedule. Controls were children aged 12–23 months with their mothers /caretakers who had received all the recommended routine vaccination as per national immunization schedule for full vaccination by the age of their first birth year.
Inclusion Criteria And Exclusion Criteria
Inclusion Criteria: Children aged 12–23 months with their mothers/caretakers living in Siraro District for at least 6 months before the date of data collection. Children who had a full address from Family folder and living with their mothers/ caretakers at the time of the study and who are permanent residents in Siraro District were included in this study.
Exclusion Criteria: Child mothers/caretakers who had missed child vaccination card and have no date of childbirth (whose vaccination cards not available or lost were excluded in order to reduce recall and selection bias) and those unable to interview due to illness and hearing problems.
Sample Size Determination
The sample size was calculated based on double population proportion formula by using Epi Info statistical software version 7.2 for unmatched case–control study design by considering the determinant variables from previous case-control studies conducted in Ethiopia and compared to get a large sample(7, 13). The predictor variable not attended postnatal care follow up considered as a significant determinant of defaulter to full vaccination from previous studies since it gave the maximum sample size. Among controls 45.9% of mothers not attended postnatal care follow up, while among cases it was 75.3% and OR = 3.58 (7). Using the assumptions of 80% power (Zβ = 0.84), 95% confidence level (Zα/2 = 1.96), a case to control ratio of 1:2 and after adding 10% non-response rate and design effect of 1.5, the total sample size was 444 (148 cases and 296 controls).
Sampling Procedures
The appropriate representative kebeles and households were selected by using multistage sampling from 32 kebeles in the district. Initially, the kebeles found in the district were stratified into urban and rural. There are 28 rural and 4 urban kebeles in the district. Eight rural and two urban kebeles were selected randomly using lottery method by considering rule of thumb (30%) of kebeles from each stratum (Fig. 1). All eligible cases and controls were listed with their full address from the Family folder of nearby health post separately for each selected kebeles before actual data collection. Family folder is a registry book containing all family members’ profiles in the kebele.
Finally,148 cases were selected using consecutive sampling based on the principles of subsequent nearest eligible households and 296 controls were selected by using simple random sampling technique after proportional allocation to the number of children aged 12 to 23 months to the number of children in each kebele using computer-generated technique. When there are two or more children in eligible household one of them were selected using lottery method. In case of absenteeism of respondents during visit, after checking three times visits the next eligible households were included.
Study Variables
Dependent Variable
Defaulter to full vaccination status
Independent Variables
Sociodemographic characteristics of mother/caretakers (age, marital status, educational status occupation, residence, family size, income)
Child biographic related characteristics (child age, sex, birth order, birth interval)
Vaccination service delivery related characteristics (time to reach health facility, waiting time, postponing schedule, parents discussion on vaccination)
Knowledge, Attitude and Service Satisfaction of mothers/ caretakers on child vaccination
Maternal Health service utilization related characteristics (Antenatal care visit, postnatal care visit, place of delivery, pregnant mother conference participation, model family training)
Measurements And Operational Definitions
Defaulter (cases)
A child aged 12 to 23 months old who had started the routine immunization and missed at least one dose of the recommended routine vaccination schedule for any reasons were considered as defaulter (6).
Full vaccination (controls)
A child aged 12–23 months who had received all the recommended routine vaccination as per national immunization schedule for full vaccination by the age of their first birth year were considered as full vaccination (6).
Knowledge about child vaccination
Mothers/caretakers were asked ten questions which are related to the child vaccination using “Yes, No and I don’t know” options. The correct answers were given a value of 1 and 0 for incorrect answers. After computing the sum score for each respondent, the minimum points to be scored were 0 and the maximum 10. The mean value of knowledge score (6.22) was used as a cut-off point to categorize knowledge into two groups. The variable was dichotomized into having “adequate knowledge” about vaccination for those respondents scored greater than or equal to mean score of knowledge points (≥ 6.22) and “inadequate knowledge” about vaccination for those respondents scored less than mean score of knowledge points (< 6.22) (4, 13).
Attitude toward child vaccination
Six questions were used to assess mothers/caretakers’ attitude towards child vaccination using five point Likert scale questions that have 1 to 5 options, were 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree. The sum score of mothers/caretakers’ attitude were computed and converted to give the minimum and maximum points of caretakers’ attitude score from 6 to 30 respectively. The variable was dichotomized into having “favorable attitude” toward child vaccination if the mothers/caretakers attitude score value greater than mean score (> 16.57), and “unfavorable attitude” toward child vaccination if the mothers/caretakers attitude score value less than or equal to mean score (≤ 16.57) (14).
Satisfaction towards child vaccination
Mothers/caretakers were asked seven service satisfaction related questions using a five point Likert scale questions that starts from 1 to 5 options (were 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree). Each variable was measured on 5 points and which together yields a minimum of 7 and a maximum of 35. A response to 7 measuring items were added and converted to give an individual level of mothers/caretakers satisfaction score from 1–100% for each item. The variable was dichotomized into “satisfied” and “not satisfied”. Mothers/caretakers who scored 75% and above on 7 satisfaction measuring items were considered as “satisfied”, and those who scored less than 75% as “not satisfied” (7).
Caretaker
Caretaker is the most responsible person who provides care to the child other than mother due to different reasons such as parents death, adoption of child, separated from family and others(6, 17).
Data Collection Tool and procedures
Data were collected using interviewer-administered structured questionnaire to obtain information from mothers/caregivers of the child by trained interviewers. The instrument was constructed from a review of available literatures on child immunization (4, 7, 13, 14). The questionnaire has seven parts, which includes sociodemographic characteristics of respondents, child biographic characteristics, child vaccination service delivery characteristics, mothers/caretakers’ knowledge on child vaccination, mothers/caretakers’ attitude towards child vaccination, immunization service satisfaction and maternal health service utilization characteristics.
The mothers/caregivers knowledge and attitude were assessed by ten and six questions respectively. Service satisfaction were assessed by seven questions related to immunization service satisfaction. For assessment of mothers/caretakers attitude and service satisfaction a five-point Likert scale questions were used and each questionnaire measures Likert scale response options scored from 1 to 5, (were 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree).
Six Diploma Nurses as data collectors and three BSc health professional supervisors were recruited based on a set of criteria, which includes understanding of the local language, Afan Oromo, and previous data collection experience. Data Collectors were trained for two days by the investigator on the purpose of the study, data collection tools or instruments, how to take consent, how to select children from households, how to interview and extract information from vaccination card and the overall data collection procedures.
Data Quality Assurance
The questionnaire was prepared in English, translated into Afan Oromo (local language of the area), and retranslated to English by other translator who is a health professional to ensure consistency of the tool. Pretest of the questionnaire was done on mothers/care givers by taking 5% of the total sample size (23 participants with 8 cases and 15 controls) in two kebeles that were not included in the study before actual data collection to identify any problems and check the clarity by ensuring the tool accurately addressed the research questions.
After the pretest the investigator, data collectors and supervisors were discussed on the questionnaire for any inconsistencies and ambiguity before actual data collection and the necessary adjustments were made on the questionnaire before using for actual data collection. Content validity of the tool was cross-checked by another health professional. Data collectors and supervisors were trained on the study instrument and data collection procedure. The investigator and supervisors were checked the collected data for consistency and completeness every day at the end of each data collection day and necessary corrective measures was taken accordingly
Data processing and analysis
The collected data were checked for completeness, consistencies and accuracy. Data were coded and entered in to Epi Data manager version 4.6, cleaned and analyzed using SPSS version 26.0. After cleaning data for inconsistencies and missing values the descriptive statistics were used to present the data with the different variables by tables and graphs. The binary logistic regression was used to identify the determinant variables. To control potential confounders, independent variables with P-value < 0.25 in the bivariable analysis was considered for multivariable logistic regression analysis and multi-collinearity of independent variables were checked by using Standard error (SE). The Standard error of 2 was used as cut off point to indicate the presence of multi-collinearity between independent variables however; in this study, it is found to be less than 2 standard error.
The model fitness test was checked by Hosmer and Lemeshow goodness of test and the model was fit to data. The statistical significance of the variables were interpreted using adjusted odd ratio (AOR) with 95% confidence interval and p-value ≤ 0.05 to identify independent determinants of defaulter to full vaccination. Finally, the result was presented in the form of text, using tables, figures and charts.