A Community-based Participatory Intervention to Change Attitudes Towards Female Circumcision Among Somali Immigrants in Sweden

NCT ID: NCT02335697

Last Updated: 2016-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-03-31

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.

Conditions

Female Circumcision; Female Genital Mutilation/Cutting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Attitude change towards female circumcision

Group Type: OTHER

Attitude change towards female circumcision

Intervention Type: BEHAVIORAL

The intervention comprises of a series of meetings between newly arrived Somalis and established Somalis. At each meeting, a pre-determined topic relating to FC will be discussed. The topics include culture, religion, health, children's rights, and Swedish laws. Different experts, chosen to match the specific topic of the meeting will be invited to each meeting to facilitate the interactive discussions between the participants. Somalis who are both familiar with the Swedish and Somali culture will facilitate the meetings. The intervention spans over a time period of six months. The intervention meetings will be held during the first five months of the intervention period; one meeting scheduled per month. Thereafter, there will be a 'wash-out' period of one month to allow for reflections and to minimize the risk of courtesy bias.

No intervention

No intervention

Group Type: OTHER

No intervention

Intervention Type: OTHER

Interventions

Attitude change towards female circumcision

The intervention comprises of a series of meetings between newly arrived Somalis and established Somalis. At each meeting, a pre-determined topic relating to FC will be discussed. The topics include culture, religion, health, children's rights, and Swedish laws. Different experts, chosen to match the specific topic of the meeting will be invited to each meeting to facilitate the interactive discussions between the participants. Somalis who are both familiar with the Swedish and Somali culture will facilitate the meetings. The intervention spans over a time period of six months. The intervention meetings will be held during the first five months of the intervention period; one meeting scheduled per month. Thereafter, there will be a 'wash-out' period of one month to allow for reflections and to minimize the risk of courtesy bias.

Intervention Type: BEHAVIORAL

No intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Malmö University

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birgitta Essén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Uppsala University

Uppsala, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 28801440 (View on PubMed)

Other Identifiers

Forte 2013-2095

Identifier Type: -

Identifier Source: org_study_id