Trial design
The two-arm parallel cluster randomized controlled trial will investigate the effectiveness of a community-based prevention program over six months on brucellosis in a rural population in Ahar, East Azerbaijan, Iran. Assessments were conducted at baseline [July 2016] and post assessment was done at 9 months after baseline measurements.
High prevalence rates of brucellosis in rural areas of Ahar and its crucial need for a community-based prevention program for brucellosis led to its selection as the study setting. Due to strong relationship among neighboring households in rural communities, it is unable to assign participants living in the same group. So, we performed a stratified randomized controlled trial in rural health houses as the units of randomization. Health houses are located in rural areas that provide health delivery facilities [17]. Sixteen health houses from sixteen villages with a high prevalence rate of brucellosis during previous two years were selected for recruitment of participants. Figure 1 shows the study flow chart. More details are included as an additional file 2.
Recruitment and Participants
Participants were randomly recruited from household health records in rural health houses from rural community that are at high risk for brucellosis.
Inclusion criteria
Participants 15 years of age or over, and living in the villages for at least 6 months after enrollment, were included in the study.
Exclusion criteria
People who were unwilling to provide consent for data collection and employees in the health centers or veterinary office were excluded from the study.
Randomization
A multi-stage random sampling method was used to select villages in the county. Ahar was stratified into four regions: north, south, west, and east. Two health centers were selected from each region and eight health houses that provided health delivery facilities and had a high prevalence rate of brucellosis during the last two years [14] were selected from each center. Participants were recruited via household health files from health houses in each village. Randomization was carried out after baseline measurements. The selected health houses were randomly allocated into intervention and control groups (eight per arm). To guarantee balance in numbers of the units allocated to each arm, permuted blocks randomization (PBD) was used for random assignment of the health houses to intervention and control groups. Randomization sequence was created manually by a biostatistician using Excel software [Command in the Excel for random block sizes column: =rand()] to assign health houses to the study arms using a 1:1 allocation ratio with block size of 4. A colleague not connected to the study was performed equal group random allocation. The participants were recruited by an independent researcher using computer-generated random number schedules from recorded lists of household health files at the health houses. Trained research assistants were conducted baseline measurements while group allocation concealment was implemented. Participants blinded to their group assignments.
Model for program planning
The PRECEDE/PROCEED model [18] was used for design development, implementation and evaluation of the brucellosis prevention and control program. PRECEDE/PROCEED includes nine phases based on assessments (PRECEDE) that should be made before planning health intervention, and evaluation (PROCEED) to enable measurement of the effectiveness of interventions at each stage of implementation, immediate and long-term effects (see Figure 2). Priority targets for intervention are established through each phase of the assessment process on the basis of importance and changeability of behavioral and ecological factors in determining brucellosis outcomes (phases 1-5). The assessment process encompasses seven behavioral and six ecological factors that have highest proportion of priority on importance and changeability (See Table 1). The evaluation (phases 7- 9) tracks the impact of the intervention on factors identified as important targets in the assessments process.
Phases 1 - Social assessment
Application of the PRECEDE/PROCEED model commences in phase 1 by assessing outcomes or goals of the intervention. The study began with diagnostic activities through gathering data on the community and identifying appropriate outcomes of the intervention. Brucellosis as a public health challenge in Ahar [7] plays a significant role in the national economy as well as in health-related quality of life (HRQOL). These phases involve assessment of the health of the target population.
Phase 2 and 3- Epidemiological, behavioral and environmental assessment
We used extensive literature review and informal discussions with selected key informants, health care staff, and veterinary and agriculture organizations in the targeted area. These activities resulted in determination of problems or issues that affect brucellosis incidence, what steps can be taken to reduce the impact of the diseases, and what needs to change to achieve prevention of brucellosis. The priority targets of behavioral and environmental risk factors for intervention on the basis of importance and changeability were determined in the target population. The process resulted in seven behavioral and six ecological factors that have highest proportion of priority on importance and changeability (See Table 1).
Phase 4 – Educational and ecological assessment
This phase helps to identify factors for intervention which if modified, would be most likely to result in behavior change. These factors are classified as predisposing, enabling, and reinforcing factors that were identified through a literature review and key informant interviews with: health workers, health care providers, experts for surveillance and control of brucellosis in health centers, veterinary specialist and experts of agriculture organizations who work on brucellosis in mentioned region. The results of this process were documented elsewhere [18]. Briefly, a standardized, structured questionnaire was used to gather information from the target population about potential routes of transmission to humans, and practices regarding dealing with aborted animal fetuses and processing and consumption of milk and dairy products. This questionnaire included five parts: predisposing, reinforcing, enabling, environmental and behavioral factors. The questionnaire was used to gather information from the target population about potential routes of transmission to humans, and practices regarding dealing with aborted animal fetuses and processing and consumption of milk and dairy products. The first part consisted of predisposing factors providing a reason or motivation to perform behavior including the knowledge, attitudes and self-efficacy about prevention; transmission and control of brucellosis. The knowledge section included 11 items that measure rural population awareness and understanding about causes, modes of transmission and protective behaviors of brucellosis. The attitudes were measured through 15 item 5-point Likert scales (strongly agree, agree, don’t know, disagree, and strongly disagree). Each of the five responses has a numerical value used to measure the belief. The self-efficacy section contains seven items with 5-point Likert-type responses (very uncertain, uncertain, don’t know, certain, and very certain). This section assessed the confidence of participants in their ability to conduct protective behavior against brucellosis.
The second part was information on reinforcing factors that encourage and support certain behavior due to social support, rewards and praise. Reinforcing factors are supporting groups such as family members’ or friends’ encouragement to take preventive measures against brucellosis. The prime source of reinforcement identified (as mentioned above through qualitative methods) in the form of social support were providing positive feedback or giving advice from family, friends and health workers. These reinforcing factors were assessed with six items assessing encouragement of behavior to be repeated and sustained by family members or friends.
The third part assessed enabling factors allowing people to act due to financial support, resources, assistance and services. This part measured access to materials, financial and educational resources including access to personal protective equipment such as gloves and masks, financial support for renovation of barns and buildings, and veterinary services for supporting regular animal vaccination against brucellosis.
The fourth part, regarding environmental factors, assessed characteristics of the environment that facilitate behavior or resources required to attain protective behavior against brucellosis. This part assessed environmental safety measures in brucellosis transmission vectors by various direct and indirect measures targeted to reduce risk of brucellosis infection and create protective measures for the environment.
Finally, the fifth part looked at behavioral factors that were evaluated by nine items such as working in pastoral livestock, regular vaccination of animals against brucellosis, consumption of pasteurized dairy products on a regular basis and wearing protective clothes during working in barns.
Phase 5 and 6-adminstrative, policy assessment and intervention
In this phase, the predisposing, enabling, and reinforcing factors that influence behavior were analyzed through results from the pre-test assessment phase 3. Then, the appropriate strategies and interventions were matched with project priority changes according with policies, resources, and organizational situations.
The first priority for intervention was identified as enabling factors. This phase requires coordinated efforts and intersectional collaboration between local public health organizations, agricultural, and veterinary organizations. The activities included continuous and constant training of health workers for brucellosis prevention, provide adequate facilities for restoration and renovation of barns, provide farmers with access to disinfectants and training for proper use of disinfectants, and compensation for farmers whose animals have died and were slaughtered due to brucellosis.
The second priority for intervention was aimed at predisposing factors: promoting knowledge, attitudes and self-efficacy of participants through designing and implementing educational interventions tailored with demographic variables.
The third priority for intervention was aimed at reinforcing factors: the main source of reinforcement as identified by local confidants, family members and friends. The activities were included encouraging more people to properly dispose of animal waste, help to bury aborted animal fetuses and support for regular animal vaccination against brucellosis, respectively.
We selected an advocacy strategy for intervention and changing policies, brucellosis occurrence, and prevention program in Ahar. The advocacy goal was built on decreasing the prevalence of brucellosis and increasing health related quality of life up to 10% in cooperation with the Health Centers, veterinary, and agricultural organizations, by the end of 2016.
Stakeholders are all those who gain or lose from reaching the goal set for our advocacy efforts. We identified stakeholders through informal interviews and consultation with related organizations. The stakeholders were categorized into four groups, including beneficiaries (farmers, household women, primary health care network of Ahar, veterinary organizations), partners (primary health care network of Ahar, farmers, veterinary and agricultural organizations), decision makers (primary health care network of Ahar, farmers, veterinary and agricultural organizations) and adversaries. The approaches and persuasion techniques of advocacy are clarified in Table 2.
Project activities integrate veterinary and public health campaigns to increase public awareness of brucellosis and to provide information about ways in which people can reduce the risk of the disease. Close cooperation and coordination between all partners is crucial to success.
Measurement tools
All participants also were asked demographic questions: gender, age, marital status, educational qualifications, job, history of brucellosis and family history of the disease. A standardized, structured questionnaire including five parts (predisposing, reinforcing, enabling, environmental and behavioral factors related to brucellosis) is used [18].
Sample size
The sample size will be calculated based on standard deviation increase in knowledge (6.8) [21] as one of the most important variables. As such a study with a power of 90% at 5% significance level, 185 participants in each group will need. Given that there might be an attrition risk, 200 participants per group would be sought. According to the total sample size of the study, from each health houses, samples proportion to the population of the health houses was considered.
Statistical analysis
The characteristics of participants were summarized as numbers and percent or means with standard deviations if appropriate. If the continuous variables were not being normally distributed, appropriate transformations were performed to close them to normal distribution.
Generalized mixed effects-model was used to analyze data. This model in cluster randomization incorporate random effects to reflect the correlation among observations made of members of the same health house. According to distribution of our outcomes, appropriate distribution and link functions were selected. For all parameters, 95% confidence intervals will be defined. Two-sided p values of less than 0.05 will be regarded as statistically significant. All analyses will be performed with the Statistical Package for Social Sciences version 23 (SPSS Inc., Chicago, IL).