Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02335697
Recruitment Status : Completed
First Posted : January 12, 2015
Last Update Posted : April 29, 2016
Sponsor:
Collaborator:
Malmö University
Information provided by (Responsible Party):
Uppsala University

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.


Condition or disease Intervention/treatment Phase
Female Circumcision Female Genital Mutilation/Cutting Behavioral: Attitude change towards female circumcision Other: No intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Community-based Participatory Intervention to Change Attitudes Towards Female Circumcision Among Somali Immigrants in Sweden: a Cluster Randomized Controlled Trial
Study Start Date : November 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Intervention
Attitude change towards female circumcision
Behavioral: 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.

No intervention
No intervention
Other: No intervention



Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) of types of female circumcision (change in what type of female circumcision the participant thinks is acceptable to do) [ Time Frame: 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.

  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) [ Time Frame: 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.

  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 Outcome Measures :
  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) [ Time Frame: 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 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.

  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) [ Time Frame: 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 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.

  3. Visual Analogue Scale (VAS) of number of individuals performing female circumcision [ Time Frame: 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 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.

  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) [ Time Frame: The outcome measure will be assessed approximately 1-30 days after the intervention. ]
    A questionnaire will be used to collect information about acceptability of the intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335697


Locations
Layout table for location information
Sweden
Uppsala University
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Malmö University
Investigators
Layout table for investigator information
Principal Investigator: Birgitta Essén, MD, PhD Uppsala University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02335697     History of Changes
Other Study ID Numbers: Forte 2013-2095
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016