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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03132389
Other study ID # 2016/2279/REK
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date July 31, 2019

Study information

Verified date March 2020
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study the investigators seek to register the prevalence of sexually transmitted infections (STI) among people attending the Sexual Assault Centre in Oslo, Norway. The main aim of this study is to gather representative data on STIs after sexual assaults. Consequently, if the attendance for medical follow up turns out to be good/sufficient, prophylactic (antibiotic) treatment can potentially be omitted.


Description:

Patients who attend sexual assault centres are often concerned about being infected with STIs. Therefore, the patients attending sexual assault centres are offered examination and often receive prophylactic treatment against some STIs (e.g. chlamydia trachomatis, HIV and hepatitis B).

In this study, the investigators seek to register the prevalence of STI among people attending the Sexual Assault Centre in Oslo, Norway. The primary aim of the study is to gather representative data on STIs after a sexual assault. Furthermore, the investigators want to evaluate if there are any variables that can predict transmission after a sexual assult. Results from this study will also be compared with findings of STI in the general population.

At the Sexual Assault Centre in Oslo, Norway, patients are routinely offered three medical follow up consultations. Consequently, if the attendance at follow up visits turns out to be adequate, prophylactic (antibiotic) treatment can potentially be omitted.

Since victims of assault are in a vulnerable situation, it would be useful to be able to inform them more precisely about infection risk and provide adequate prophylactic treatment. More knowledge about the incidence of infection after abuse will increase patient safety and improve the quality of treatment for these patients.


Recruitment information / eligibility

Status Completed
Enrollment 640
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria:

- Patients attending and examined after sexual assault at the Sexual Assault Centre in Oslo (at Oslo Accident and Emergency Outpatient Clinic).

- Written informed consent

Exclusion Criteria:

- Patients who only had a consultation only with a social worker and no medical examination.

- Unable to communicate in Norwegian, Swedish, Danish or English language

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
All patients included in the study will be offered the same examination and treatment procedure as the patients who are not included. Identical procedures and examinations will be performed in participants and non-participants.

Locations

Country Name City State
Norway Sexual Assault Centre in Oslo Oslo

Sponsors (2)

Lead Sponsor Collaborator
University of Oslo Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Results of the STI-tests taken at the primary examination and at follow up. Results of the STI-tests (i.e. Chlamydia trachomatis, Mycoplasma genitalium, Neisseria gonorrhoeae, Hepatitis B, Hepatitis C, HIV, Syphilis) taken at the primary attendance and at follow up. 1 week
Secondary Attendance percentage for follow up visits. 3 months
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