CClinicalTrials.gg
CompletedNCT02335697Updated Apr 29, 2016

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

An interventional study of Attitude change towards female circumcision and No intervention in Female Circumcision and Female Genital Mutilation/Cutting, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-29.

Sponsored by Uppsala University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
372
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Female Circumcision
  • Female Genital Mutilation/Cutting
03

In context

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
372 participants (actual)

Study arms

  • Other
    Intervention

    Attitude change towards female circumcision

    Behavioral: Attitude change towards female circumcision

  • Other
    No intervention

    No intervention

    Other: No intervention

Interventions

  • BehavioralAttitude 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.

  • OtherNo intervention
06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale (VAS) of types of female circumcision (change in what type of female circumcision the participant thinks is acceptable to do)

    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.

    Time frame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.

  2. 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)

    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.

    Time frame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.

  3. The change in proportion of participants who oppose the continuation of female circumcision

    Time frame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention

Secondary outcomes

  1. 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)

    In the VAS, 0 mm indicates that the participant assesses that Somali men in Sweden think that performing any type of female circumcision is not acceptable, and 100 mm indicates that the participant assesses that Somali men in Sweden think performing any type of female circumcision is acceptable. The outcome will be the change in the participant's assessment, as measured by the change from the pre-intervention score.

    Time frame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.

  2. 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)

    In the VAS, 0 mm indicates that the participant assesses that Somali women in Sweden think performing any type of female circumcision is acceptable, and 100 mm indicates that the participant assesses that Somali women in Sweden think that performing all types of female circumcision is acceptable. The outcome will be the change in the participant's assessment, as measured by the change from the pre-intervention score.

    Time frame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.

  3. Visual Analogue Scale (VAS) of number of individuals performing female circumcision

    In the VAS, 0 mm indicates that the participant assesses that no one within the Somali community in Sweden circumcise their daughters, and 100 mm indicates that the participant assesses that everybody within the Somali community in Sweden circumcise their daughters. The outcome will be the change in the participant's assessment, as measured by the change from the pre-intervention score.

    Time frame: The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention.

  4. Change in answers to questions specifically related to one of the five topics of the intervention meetings

    Time frame: The outcome measures will be assessed before the intervention and approximately 1-30 days after the intervention.

  5. Outcomes will be analyzed for associations with number of attended intervention meetings.

    Time frame: The outcome measure will be assessed approximately 1-30 days after the intervention.

  6. Acceptability (questionnaire will be used to collect information about acceptability of the intervention)

    A questionnaire will be used to collect information about acceptability of the intervention.

    Time frame: The outcome measure will be assessed approximately 1-30 days after the intervention.

07

Study locations

1 site
  • Uppsala University
    Uppsala, 75185, Sweden
08

References and documents

Publications

  • 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. PubMed 28801440 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02335697
Lead sponsor
Uppsala University
Collaborators
Malmö University
Responsible party
Sponsor
First posted
Jan 12, 2015
Start date
Nov 2014
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Apr 29, 2016

Study contacts

Birgitta Essén, MD, PhD
principal investigator · Uppsala University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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