Effect of Community-Based Interventions on Increasing Family Planning Utilization in Pastoralist Community
Condition: Family Size
Study type: Interventional

Summary: 
      The cluster randomized controlled trial was done in Pastoralist community of Afar region,
      Ethiopia for a total of nine months. There was three arms in the study. The type of
      randomization will be a cluster randomized controlled trial where kebele are randomized to
      two different interventions and control groups. These interventions are women education to
      use family planning and male education/involvement to enhance family planning use in the
      community.
    

Detailed description: 
      The study hypothesized that doing on women education and men education/involvement in family
      planning utilization would be a practical way to achieve for an increment of family planning
      utilization in Pastoralist community of Afar region. The study was carried out in Afar
      region, North Eastern Ethiopia from Jan1, 2018, to September 5, 2018. A three-arm, parallel
      randomized controlled trial was used to answer the objective of the study. The type of
      randomization will be a cluster randomized controlled trial where kebele are randomized to
      two different interventions and one control groups together. These interventions are women
      education to use family planning and male education/involvement to enhance family planning
      use in the community.

      The unit of randomization was clustered which are kebeles in a different districts. From a
      given district 11 Kebele were selected randomly gives a total of 33 kebele. The 33 cluster
      were allocated to the 2 interventions and one control arms. The detail description of the two
      interventions and one control arm is described below.

        -  Arm 1): existing standard family planning service provision by the government health
           sectors.

        -  Arm 2): It focuses on the involvement of men to enhance the utilization of family
           planning by their wives and educating the women in the male intervention area.

        -  Arm 3): It deals with educating married women to use family planning.

      Data collection tool, procedures, and follow-up We develop the quantitative tool based on the
      previous finding in the region. It contains baseline and end line data collection with a
      nine-month duration. The tool was piloted on 10% (118) of the sample and it was tested for
      reliability and validity test for items of of knowledge, attitude, subjective norm, perceived
      behavioral control over FP use, intention to use for FP and male involvement. Accordingly,
      modification was made based on the finding of reliability and validity test. A tool which has
      a All items were subjected to exploratory factor analysis to identify the relevant
      constructs. Items with low load factor (less than 0.3) to the identified constructs were
      deleted. Then the reliability test was done to assess the consistency of items in each
      construct (Cronbach's Alpha > 0.7). At the end, a final tool was prepared based on the
      finding of the reliability and validity test. Then, it was pretested in 5% (45) of the
      sample. 6 clinical nurse data collectors and 2 supervisors were used to collect the data
      after they got training on the items and how to use mobile based application. They were
      assigned to a different cluster of a given district. The data was collected using mobile
      based application called open data kit (ODK) for a one month. A similar procedure was used in
      the end line data collection. Immediately after the data checked for its completeness, it was
      sent to the Mekelle University (MU) Server. Hence, at the middle of the intervention,
      qualitative data was collected to identify the participants acceptability and documenting
      best experience of the intervention.

      Intervention description:

      The community-based intervention in this study includes two components. These are educating
      women to use family planning and male involvement for use of family planning.

      Analysis plan and statistics methods The type of data used in the intervention study was a
      repeated cross-sectional. The data collected using ODK, was exported to R software version
      3.4.2 for analysis.Intention to treat analysis was used as a framework of analysis. All the
      analysis was used with 95% confidence interval and p-value <0.05 to declared statistically
      significant. Since the number of clusters per arm was 11, a cluster level summary was used to
      compare the control group with the intervention (women education and male involvement). A
      separate cluster level summaries analysis was done for control Vs the women arm and control
      with the male arm by considering the effect of cluster. Finally, the result was described
      with t-test, df, P-value, mean value of both group and 95% CI of the adjusted risk. Moreover,
      prevalence ratio of the end line FP user over the baseline FP was done.

      Ethical consideration Permission to undertake the study was obtained from Mekelle University
      College of Health Sciences institutional review board with a reference number ERC 1435/2018.
      And an official letter of cooperation was given to Afar Regional Health Bureau. Permission
      was obtained from all relevant authorities in the Afar regional health bureau and
      participating district health offices (Afambo, Kori and Mille). At the beginning community
      consent was secured from the influential group (religious and clan leader). Verbal consent
      was secured before conducting interviews and parental/guardian consent was waived to include
      the minors to the study by the ethical board. The informed consent was secured continuously
      every three months. A one-page consent letter was attached to the cover page of each
      questionnaire as an information sheet which includes a detail description about the benefit
      and risk of participating in the study, participation is on voluntary basis, the right to
      withdraw from the study, identification of informant was possible only through specific
      identification numbers and the privacy of collected information. Data collection was
      conducted through electronically smartphone mobile based application (ODK) and it was
      confidentially.
    

Intervention name(s): Women Education; Male Involvement; Control group
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): This intervention intends to provide health education message for women enhance FP utilization in pastoralist community. It was cognizant that, Ethiopia is the second most populous country in Africa. And there is a great discrepancy between contraceptive use, unmet need for FP and maternal and child morbidity and mortality between the pastoralist and agrarian community. Pastoralist community in the country expressed as low contraceptive users, a high unmet need for FP and highest maternal and child morbidity and mortality. The previous study indicates that only 5.4% of the women use contraceptive. The most common reason mentioned for not using of contraceptive are lack of awareness, demand for a large number of children and male dominance in all decision making power in general and FP in particular. In light of this, the study hypothesized that working with men and educating women towards the use of FP could enhance the use of family planning utilization.; Male involvement was a feature of intervention in this arm. Comprehensive health education about FP was given in addition to the video message about FP. In pastoralist community the most reason mentioned for not using of FP are husband objection and religion influence. And most of the decisions are in the palm of husband to seek care for reproductive, maternal and neonatal health in general and FP in particular. Besides, the pastoralist community manifested by high total fertility rate and maternal and child morbidity and mortality.; The third group in this community based intervention was following the community without provision of male iand married women education. In this group there was no intervention by the researchers. However, the activities performed by the government about family planning provision was maintained.
Other intervention name(s): Women empowerment; women empowerment through men involvement; Active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The cluster randomized controlled trail will be designed to enhance family planning (FP) utilization in pastoralist community. An integrated behavioral model was used to guide the intervention. It has three arm and these are two community-based intervention and one control group and it was carried out for 9 months. Baseline and end line data was collected. The package of health education message was given to the married women of both arm (women and male involvement) arm and men in the male arm. Different modality was used in the men and women arm. These are involving faema leader, use of audiovisual materials of role model person in the community and providing training for health extension workers (HEW) and health care provider to assist for the faema leader.
Masking: Single (Participant)
Primary purpose: Health Services Research