Clinical trial NCT02335697: A Community-based Participatory Intervention to Change Attitudes Towards Female Circumcision Among Somali Immigrants in Sweden
Official title: A Community-based Participatory Intervention to Change Attitudes Towards Female Circumcision Among Somali Immigrants in Sweden: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Circumcision
Female Genital Mutilation/Cutting
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Malmö University
First posted: 2015-01-12
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Visual Analogue Scale (VAS) of types of female circumcision (change in what type of female circumcision the participant thinks is acceptable to do)
timeFrame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.
measure: 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)
timeFrame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.
measure: The change in proportion of participants who oppose the continuation of female circumcision
timeFrame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention
Secondary outcomes:
measure: 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)
timeFrame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.
measure: 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)
timeFrame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.
measure: Visual Analogue Scale (VAS) of number of individuals performing female circumcision
timeFrame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.
measure: Change in answers to questions specifically related to one of the five topics of the intervention meetings
timeFrame: The outcome measures will be assessed before the intervention and approximately 1-30 days after the intervention.
measure: Outcomes will be analyzed for associations with number of attended intervention meetings.
timeFrame: The outcome measure will be assessed approximately 1-30 days after the intervention.
measure: Acceptability (questionnaire will be used to collect information about acceptability of the intervention)
timeFrame: The outcome measure will be assessed approximately 1-30 days after the intervention.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Birgitta Essén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wahlberg A, Johnsdotter S, Selling KE, Kallestal C, Essen B. Baseline data from a planned RCT on attitudes to female genital cutting after migration: when are interventions justified? BMJ Open. 2017 Aug 11;7(8):e017506. doi: 10.1136/bmjopen-2017-017506.