Home-sampling in Partner Notification of Chlamydia

Not Applicable

Completed

• Conditions: Chlamydia
• Interventions: Behavioral: Contact tracing mode test at clinic; Behavioral: Self-sampling at home - Sent Test Kit

• Registration Number: NCT01596946
• Lead Sponsor: Ostergotland County Council, Sweden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Status Verified: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-10
• Last Update Submitted: 2012-05-10
• Study First Posted: 2012-05-11
• Last Update Posted: 2012-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 633

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contact tracing mode test at clinic	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.
Self-sampling at home	Self-sampling at home - Sent Test Kit	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.

Primary Outcome Measures

Name	Time	Method
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	60 days or more were defined as an exclusion criterion	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.

Trial Locations

Locations (1)

R&D department of Local Health Care; 🇸🇪 Linköping, Sweden