Home-sampling in Partner Notification of Chlamydia

Chlamydia Clinical Trial

Official title:

Home-sampling as a Tool in a Chlamydia Trachomatis Partner Notification Context. A Multi-centre Cluster-randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596946
• Other study ID #: Forss8743, LiO 201 261
• Status: Completed
• Phase: N/A
• First received: May 9, 2012
• Last updated: May 10, 2012
• Start date: November 2006
• Est. completion date: November 2011

Study information

• Verified date: May 2012
• Source: Ostergotland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 633
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chlamydia
• Chlamydia Infections

Intervention

Behavioral:
• Contact tracing mode test at clinic

• Self-sampling at home - Sent Test Kit

Locations

Country	Name	City	State
Sweden	R&D department of Local Health Care	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
Ostergotland County Council, Sweden	Medical Research Council of Southeast Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	60 days or more were defined as an exclusion criterion	No