Home-sampling in Partner Notification of Chlamydia

NCT ID: NCT01596946

Last Updated: 2012-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

633 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-11-30

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.

Detailed Description

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Conditions

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Chlamydia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Contact tracing mode test at clinic

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Self-sampling at home - Sent Test Kit

Intervention Type BEHAVIORAL

Interventions

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Contact tracing mode test at clinic

Intervention Type BEHAVIORAL

Self-sampling at home - Sent Test Kit

Intervention Type BEHAVIORAL

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Research Council of Southeast Sweden

OTHER_GOV

Sponsor Role collaborator

Ostergotland County Council, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Lars Falk

MD PhD consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Falk, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Östergötland CC

Locations

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R&D department of Local Health Care

Linköping, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Forss8743, LiO 201 261

Identifier Type: -

Identifier Source: org_study_id

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