- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01596946
Home-sampling in Partner Notification of Chlamydia
May 10, 2012 updated by: Lars Falk, Ostergotland County Council, Sweden
Home-sampling as a Tool in a Chlamydia Trachomatis Partner Notification Context. A Multi-centre Cluster-randomized Controlled Trial.
Though partner notification is mandatory to perform of Chlamydia trachomatis infected individuals in Sweden, there was a 10-15% annually increase of reported cases between 1997 and 2007 indicating that partner notification may not be effective in preventing transmission.
The investigators wanted to determine whether there was any difference in time between home-sampling and clinical testing as a tool of partner notification measured from eliciting of partners to date of testing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
633
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Linköping, Sweden, 581 85
- R&D department of Local Health Care
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sexual Partners to chlamydia infected index patients accepting to participate in the study.
Exclusion Criteria:
Index patients not living in Sweden or not speaking Swedish.
- MSM.
- Sexual partners living in another county or abroad.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Contact tracing mode test at clinic
Conventional mode of contact tracing where the partners were asked by either the index patient or demanded by the counsellor to attend a clinic for C. trachomatis testing.
The date of testing for chlamydia of the study subject i e a sexual partner to a chlamydia infected index patient was noted.
Those partners being C trachomatis positive were referred to the STD-clinic for contact tracing and following the same study arm a the index patient.
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EXPERIMENTAL: Self-sampling at home
The intervention: Self-sampling of sexual partners to infected index patient for chlamydia by urine test or vaginal sampling at home.
They sent the kit tube to a microbiological laboratorium for analysis.
The test kit was sent by post by the counsellor at the STD-clinic or distributed via the index patient.
The partner in this arm was informed about the test result from the STD-clinic and those tested C trachomatis positive were given an appointment for treating and contact tracing as soon as possible.
Their partners were not randomised but following the same mode.
The days from the counselling conversation with the index patient to the date of testing was measured and compared with partners tested following arm 1 mode.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in time, measured as days from the meeting between the index patient and the counsellor (i.e. the eliciting of sexually partners) until the date of C. trachomatis testing of partners
Time Frame: 60 days or more were defined as an exclusion criterion
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Difference in time, measured as days from the meeting between the index patient and the counsellor (i.e. the eliciting of sexually partners) until the date of C. trachomatis testing of partners, if sexual partners had attended a clinic for testing or had the opportunity of home-sampling.
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60 days or more were defined as an exclusion criterion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lars Falk, MD PhD, Ostergotland CC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (ACTUAL)
October 1, 2011
Study Completion (ACTUAL)
November 1, 2011
Study Registration Dates
First Submitted
May 9, 2012
First Submitted That Met QC Criteria
May 10, 2012
First Posted (ESTIMATE)
May 11, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 11, 2012
Last Update Submitted That Met QC Criteria
May 10, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Forss8743, LiO 201 261
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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