Female Circumcision Clinical Trial
Official title:
A Community-based Participatory Intervention to Change Attitudes Towards Female Circumcision Among Somali Immigrants in Sweden: a Cluster Randomized Controlled Trial
| Verified date | April 2016 |
| Source | Uppsala University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 372 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Uppsala University | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| Uppsala University | Malmö University |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention. | No |
| Primary | 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. | The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention. | No |
| Primary | The change in proportion of participants who oppose the continuation of female circumcision | The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention | No | |
| Secondary | 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. | The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention. | No |
| Secondary | 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. | The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention. | No |
| Secondary | 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. | The outcome measure will be assessed before the intervention and approximately 1-30 days after the intervention. | No |
| Secondary | 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. | No | |
| Secondary | 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. | No | |
| Secondary | 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. | The outcome measure will be assessed approximately 1-30 days after the intervention. | No |