Sexual Assault and RapeNCT03132389
Prevalence of Sexually Transmitted Infections Among People Attending the Sexual Assault Centre in Oslo, Norway.
An observational study of Sexual Assault and Rape and Sexually Transmitted Diseases, run by University of Oslo at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Sexual Assault and Rape, Sexually Transmitted Diseases
- How many people
- 640 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2017to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients attending and examined after sexual assault at the Sexual Assault Centre in Oslo (at Oslo Accident and Emergency Outpatient Clinic).
Who may be able to join
- Patients attending and examined after sexual assault at the Sexual Assault Centre in Oslo (at Oslo Accident and Emergency Outpatient Clinic).
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Being tested
- No intervention
- Keywords
- Sexual assault, Sexually transmitted diseases, Chlamydia trachomatis, Mycoplasma genitalium, Neisseria gonorrhoeae, Hepatitis B and C, HIV, Syphilis, Follow up visits after sexual assault
- Medical subject headings
- Sexually Transmitted Diseases, Hepatitis B, Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
Attendance percentage for follow up visits.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 May 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual Assault and RapeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Odd Martin Vallersnes, University of Oslo
- Investigators
- Mette Brekke, Professor, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132389
- Sponsor's protocol ID
- 2016/2279/REK
- Status last verified
- Mar 2020
- First submitted
- 24 Apr 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skjaelaaen K, Nesvold H, Brekke M, Sare M, Landaas ET, Mdala I, Olsen AO, Vallersnes OM. Sexually transmitted infections among patients attending a sexual assault centre: a cohort study from Oslo, Norway. BMJ Open. 2022 Dec 1;12(12):e064934. doi: 10.1136/bmjopen-2022-064934.
PubMed 36456026
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03132389
- Acronym / sponsor ID
- 2016/2279/REK
- Keywords
- Sexual assault, Sexually transmitted diseases, Chlamydia trachomatis, Mycoplasma genitalium, Neisseria gonorrhoeae, Hepatitis B and C, HIV, Syphilis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients attending after a sexual assault | – | Other: No interventionPatients attending and examined after sexual assault at the Sexual Assault Centre in Oslo, who have given informed consent to inclusion in the study. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients attending and examined after sexual assault at the Sexual Assault Centre in Oslo (at Oslo Accident and Emergency Outpatient Clinic).
Key inclusion criteria (2 listed)
- Patients attending and examined after sexual assault at the Sexual Assault Centre in Oslo (at Oslo Accident and Emergency Outpatient Clinic).
- Written informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAll 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. | Other | Patients attending after a sexual assault |
Primary outcome
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.
1 secondary outcome
Attendance percentage for follow up visits.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 36456026Skjaelaaen K, Nesvold H, Brekke M, Sare M, Landaas ET, Mdala I, Olsen AO, Vallersnes OM. Sexually transmitted infections among patients attending a sexual assault centre: a cohort study from Oslo, Norway. BMJ Open. 2022 Dec 1;12(12):e064934. doi: 10.1136/bmjopen-2022-064934.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Brekke, Professor study director
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Assault and Rape and Sexually Transmitted Diseases, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of the STI-tests taken at the primary examination and at follow up. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03132389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.