NCT03132389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

April 24, 2017

Last Update Submit

March 24, 2020

Conditions

Keywords

Sexual assaultSexually transmitted diseasesChlamydia trachomatisMycoplasma genitaliumNeisseria gonorrhoeaeHepatitis B and CHIVSyphilisFollow up visits after sexual assault

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Attendance percentage for follow up visits.

    3 months

Study Arms (1)

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

Interventions

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.

Patients attending after a sexual assault

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sexual Assault Centre in Oslo

Oslo, 0180, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sexually Transmitted DiseasesHepatitis BSyphilis

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesTreponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, Bacterial

Study Officials

  • Mette Brekke, Professor

    University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 27, 2017

Study Start

May 1, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations