Home-sampling in Partner Notification of Chlamydia

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council of Southeast Sweden
Information provided by (Responsible Party):
Lars Falk, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT01596946
First received: May 9, 2012
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Chlamydia
Behavioral: Contact tracing mode test at clinic
Behavioral: Self-sampling at home - Sent Test Kit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Home-sampling as a Tool in a Chlamydia Trachomatis Partner Notification Context. A Multi-centre Cluster-randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Ostergotland County Council, Sweden:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 633
Study Start Date: November 2006
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Contact tracing mode test at clinic
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.
Behavioral: Self-sampling at home - Sent Test Kit

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01596946

Locations
Sweden
R&D department of Local Health Care
Linköping, Sweden, 581 85
Sponsors and Collaborators
Ostergotland County Council, Sweden
Medical Research Council of Southeast Sweden
Investigators
Principal Investigator: Lars Falk, MD PhD Östergötland CC
  More Information

No publications provided

Responsible Party: Lars Falk, MD PhD consultant, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier: NCT01596946     History of Changes
Other Study ID Numbers: Forss8743, LiO 201 261
Study First Received: May 9, 2012
Last Updated: May 10, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Ostergotland County Council, Sweden:
contact tracing
home sampling
cluster randomisation

Additional relevant MeSH terms:
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 24, 2014