A Community-based Participatory Intervention to Change Attitudes Towards Female Circumcision Among Somali Immigrants in Sweden: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS) of types of female circumcision (change in what type of female circumcision the participant thinks is acceptable to do)
研究概览
简要总结
Female circumcision (FC) causes both immediate and long-term health consequences. In general, the more severe type of FC, the worse health consequences can be seen. Despite the negative health effects, the practice of FC is still found to be highly prevalent in many countries, mainly in Africa and the Middle East. Many studies have been performed on FC in African countries where the custom is widespread and there have also been many attempts to eradicate the practice in these countries. However, considerably less research exists on FC in non-practicing societies where there has been an influx of immigrants from countries that traditionally carry out this practice. Further, no anti-FC interventions designed using a comparison group have been performed in any country outside Africa.
This cluster randomized controlled trial aims to evaluate the effectiveness of a community-based participatory intervention on changing attitudes towards FC among newly arrived Somali immigrants in Sweden. Included in the research is an assessment of the acceptability of the intervention. Based on social convention theory, we hypothesize that an interaction between established Somali immigrants, thought to be predominantly opponents of FC, and newly arrived Somali immigrants will facilitate changes in attitudes among the newly arrived.
The trial will be implemented in two municipalities in Sweden that have a high proportion of Somali immigrants. Somali organizations in these municipalities will constitute the clusters. In total, 8 clusters will be included, 4 intervention clusters and 4 control clusters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Oral informed consent
- •Newly arrived (lived in Sweden for ≤ 4 years) Somali immigrants in Sweden with a residence permit
- •Men and women, ≥ 18 years old
排除标准
- 未提供
结局指标
主要结局
Visual Analogue Scale (VAS) of types of female circumcision (change in what type of female circumcision the participant thinks is acceptable to do)
时间窗: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.
In the VAS, 0 mm indicates that no type of female circumcision is regarded as acceptable to do, and 100 mm indicates that all types of female circumcision are regarded as acceptable to do. The outcome will be the change in what type of female circumcision the participant thinks is acceptable to do, as measured by the change from the pre-intervention score.
The change in proportion of participants who oppose the continuation of female circumcision
时间窗: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention
Visual Analogue Scale (VAS) of types of female circumcision (change in what type of female circumcision the participant would perform if he/she had a daughter, as measured by the change from the pre-intervention score)
时间窗: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.
In the VAS, 0 mm indicates that the participant would not perform any type of female circumcision on his/her hypothesized daughter, and 100 mm indicates that the participant would perform the most extensive type of female circumcision on his/her hypothesized daughter. The outcome will be the change in what type of female circumcision the participant would perform if he/she had a daughter, as measured by the change from the pre-intervention score.
次要结局
- Visual Analogue Scale (VAS) of types of female circumcision (participant assesses that Somali men in Sweden think that performing any type of female circumcision is not acceptable or acceptable)(The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.)
- Visual Analogue Scale (VAS) of number of individuals performing female circumcision(The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.)
- Change in answers to questions specifically related to one of the five topics of the intervention meetings(The outcome measures will be assessed before the intervention and approximately 1-30 days after the intervention.)
- Outcomes will be analyzed for associations with number of attended intervention meetings.(The outcome measure will be assessed approximately 1-30 days after the intervention.)
- Visual Analogue Scale (VAS) of types of female circumcision (participant assesses that Somali women in Sweden think performing any type of female circumcision is acceptable or not acceptable)(The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.)
- Acceptability (questionnaire will be used to collect information about acceptability of the intervention)(The outcome measure will be assessed approximately 1-30 days after the intervention.)