NCT00827970

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 1997

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1998

Completed
9.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
Last Updated

January 23, 2009

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

January 22, 2009

Last Update Submit

January 22, 2009

Conditions

Chlamydia TrachomatisInfertilityEctopic Pregnancy

Keywords

mass screening

Outcome Measures

Primary Outcomes (1)

  • Long term infertility complications

    2008

Study Arms (2)

1 Screening

EXPERIMENTAL

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

Behavioral: Screening for urogenital Chlamydia trachomatis

2 Control

NO INTERVENTION

Control group receiving usual care

Interventions

Screening for urogenital Chlamydia trachomatisBEHAVIORAL

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

1 Screening

Eligibility Criteria

Age21 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Diseases, Aarhus University Hospital Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 11807700RESULT

  • 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.

    PMID: 21097811DERIVED

MeSH Terms

Conditions

InfertilityPregnancy, Ectopic

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Berit Andersen, MD, Ph.D.

    Aarhus University Hospital Skejby, Department of Infectious Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

October 1, 1997

Primary Completion

February 1, 1998

Study Completion

August 1, 2007

Last Updated

January 23, 2009

Record last verified: 2009-01

Locations

DK(1)