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Prevalence of Sexually Transmitted Infections Among People Attending the Sexual Assault Centre in Oslo, Norway.

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ClinicalTrials.gov Identifier: NCT03132389
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : June 19, 2017
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Odd Martin Vallersnes, University of Oslo

Brief 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.

Condition or disease Intervention/treatment
Sexual Assault and Rape Sexually Transmitted Diseases Other: No intervention

Detailed 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.


Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Sexually Transmitted Infections Among People Attending the Sexual Assault Centre in Oslo, Norway: a Cohort Study at the Sexual Assault Centre in Oslo, Norway.
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients attending after a sexual assault
Patients attending and examined after sexual assault at the Sexual Assault Centre in Oslo, who have given informed consent to inclusion in the study.
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.



Primary Outcome Measures :
  1. Results of the STI-tests taken at the primary examination and at follow up. [ Time Frame: 1 week ]
    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.


Secondary Outcome Measures :
  1. Attendance percentage for follow up visits. [ Time Frame: 3 months ]


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients attending and examined after sexual assault at the Sexual Assault Centre in Oslo (at Oslo Accident and Emergency Outpatient Clinic).
Criteria

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

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): NCT03132389


Contacts
Contact: Odd Martin Vallersnes, PhD, MD +4793082583 o.m.vallersnes@medisin.uio.no
Contact: Katarina Skjaelaaen, MD +4792066614 skjaelaaen@hotmail.com

Locations
Norway
Sexual Assault Centre in Oslo Recruiting
Oslo, Norway, 0180
Sponsors and Collaborators
University of Oslo
Oslo University Hospital
Investigators
Study Director: Mette Brekke, Professor University of Oslo

Responsible Party: Odd Martin Vallersnes, Associate professor, University of Oslo
ClinicalTrials.gov Identifier: NCT03132389     History of Changes
Other Study ID Numbers: 2016/2279/REK
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Odd Martin Vallersnes, University of Oslo:
Sexual assault
Sexually transmitted diseases
Chlamydia trachomatis
Mycoplasma genitalium
Neisseria gonorrhoeae
Hepatitis B and C
HIV
Syphilis
Follow up visits after sexual assault

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Wounds and Injuries
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female