Randomized Population-Based Study on Chlamydia Trachomatis Screening

NCT ID: NCT00827970

Last Updated: 2009-01-23

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

30000 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-10-31

Study Completion Date

2007-08-31

Brief Summary

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30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.

The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.

Detailed Description

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Conditions

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Chlamydia Trachomatis Infertility Ectopic Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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1 Screening

Individuals receiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.

Group Type EXPERIMENTAL

Screening for urogenital Chlamydia trachomatis

Intervention Type BEHAVIORAL

Receeiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.

2 Control

Control group receiving usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Screening for urogenital Chlamydia trachomatis

Receeiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* born in 1974, 1974 or 1976 AND living in Aarhus County October 1007

Exclusion Criteria

\-
Minimum Eligible Age

21 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus County, Denmark

OTHER

Sponsor Role collaborator

Novo foundation

UNKNOWN

Sponsor Role collaborator

The Danish Medical Research Council

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Aarhus University Hospital Skejby, Department of Infectious Diseases

Principal Investigators

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Berit Andersen, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital Skejby, Department of Infectious Diseases

Locations

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Department of Infectious Diseases, Aarhus University Hospital Skejby

Aarhus N, , Denmark

Site Status

Countries

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Denmark

References

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Andersen B, Olesen F, Moller JK, Ostergaard L. Population-based strategies for outreach screening of urogenital Chlamydia trachomatis infections: a randomized, controlled trial. J Infect Dis. 2002 Jan 15;185(2):252-8. doi: 10.1086/338268. Epub 2002 Jan 3.

Reference Type RESULT
PMID: 11807700 (View on PubMed)

Andersen B, van Valkengoed I, Sokolowski I, Moller JK, Ostergaard L, Olesen F. Impact of intensified testing for urogenital Chlamydia trachomatis infections: a randomised study with 9-year follow-up. Sex Transm Infect. 2011 Mar;87(2):156-61. doi: 10.1136/sti.2010.042192. Epub 2010 Nov 20.

Reference Type DERIVED
PMID: 21097811 (View on PubMed)

Other Identifiers

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Cesoirs01

Identifier Type: -

Identifier Source: org_study_id

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