Home-sampling in Partner Notification of Chlamydia

Study Overview
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Brief Summary
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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.

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

Conditions
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Chlamydia

Intervention / Treatment
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* Behavioral: Contact tracing mode test at clinic
* Behavioral: Self-sampling at home - Sent Test Kit


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Contact tracing mode test at clinic<br>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<br> <br> |
| Experimental: Self-sampling at home<br>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<br> <br> |

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact tracing, home sampling, cluster randomisation