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临床试验/NCT03450564
NCT03450564已完成不适用

The Effect of Community-Based Interventions on Increasing Family Planning Utilization in Pastoralist Community of Afar Region Ethiopia: A Cluster Randomized Controlled Trial

Mekelle University2 个研究点 分布在 1 个国家目标入组 891 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
891
试验地点
2
主要终点
Family planning utilization

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

The study was masked to the participants in which they don't disclose the type of intervention.

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • A household was considered eligible for the study if the following criteria are met:
  • at least one married women with reproductive age group (15-49) year's child
  • able to provide a consent and voluntary to participate in the study
  • Cluster which has more than 30 married women. A household was excluded if the woman or her husband will not volunteer to participate in the study.

排除标准

  • Married women who are not volunteer to provide informed consent
  • Married women who are declared infertile

研究组 & 干预措施

Control group

Other

The third arm in this community-based intervention was following the community without provision of male and married women education. In this arm, there was no intervention by the researchers. However, the activities performed by the government about family planning provision was maintained.

干预措施: Control group (Other)

Women Education

Experimental

In the married women arm there was an intervention with health education provision based on the baseline finding so as to fill the gap.Faema leader and video from (role model women who start to use FP, FP experts was used.Health extension workers were responsible in assisting the faema leader. Twice a month there was a provision of health education message about family planning for a total of 9 months.

干预措施: Women Education (Behavioral)

Male Involvement

Experimental

In the married women arm there was an intervention with health education provision based on the baseline finding so as to fill the gap.Faema leader and video from (role model women who start to use FP, model who allows his wife to use FP, religious leader, FP experts was used.Health extension workers were responsible in assisting the faema leader. Twice a month there was a provision of health education message about family planning for a total of 9 months.

干预措施: Male Involvement (Behavioral)

结局指标

主要结局

Family planning utilization

时间窗: 9 months

the family planning utilization will be assessed by asking the participant either use or not use of contraceptive during data collection.Both the ever use or current use of the family planning will be collected from the married women.

次要结局

  • Intention to use family planning(9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mussie Alemayehu

Principal Investigator

Mekelle University

研究点 (2)

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