Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women.

NCT00283127 | Completed

• 1 other identifier: 2.2005.1223
• Study Type: interventional
• Target: 41,719
• Locations: 1 country
• Sites: 1

Brief Summary

Urogenital Chlamydia trachomatis infection is the most common bacterial sexually transmitted infection in Norway. Urogential C.trachomatis infection can easily be treated with antibiotics. However, left untreated it is a major cause of pelvic inflammatory disease (PID) that can lead to complications such as infertility, ectopic pregnancy and chronic pelvic pain in women. Most infections are asymptomatic and many do not seek the doctor for testing. Therefore cases remain undetected and untreated.We want to determine the efficacy and feasibility of screening for urogenital C. trachomatis infection with home sampling (intervention) compared to the current strategy of conventional sampling at the doctor's office (control) in identifying men and women aged 18-25 years with urogenital C.trachomatis infection (Part A). We also want to identify factors influencing the acceptability of home sampling for C.trachomatis infections (Part B)and determine factors associated with C.trachomatis infections (Part C).

Conditions

Chlamydia Trachomatis; Mass Screening

Keywords

Chlamydia trachomatis; Mass screening; Home sampling; Urine test

Outcome Measures

Primary Outcomes (3)

• Yield ratio tested for uro-genital C.trachomatis infection

• Yield ratio diagnosed for uro-genital C.trachomatis infection

• Yield ratio treated for uro-genital C.trachomatis infection

Interventions

Home sampling (urine test) for uro-genital C.trachomatis. PROCEDURE

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All persons in the population register in Rogaland County from 18-25 years of age (born between 1/1-1980 - 31/12 -1987) registered 01.11.05. Per 11.11.2005 the size of this population was 41 793. The age cut off is decided because this is the age group with the highest incidence of Chlamydia infections.

You may not qualify if:

• All persons in the population register in Rogaland born between 1/1-1980 - 31/12 -1987 registered as:
• living abroad (including Svalbard) - 6 persons
• without (permanent) address - 49 persons
• with client address- 6 persons with secret adress - 16 persons
• military - 1 person
• In total 78 persons were excluded

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead

Study Sites (1)

Norwegain Institute of Public Health

Oslo, Oslo County, 0403, Norway

Location

Related Publications (7)

• Schachter J. Chlamydial infections. West J Med. 1990 Nov;153(5):523-34. No abstract available.

  PMID: 2260289 BACKGROUND

• Strand RH, Skjeldestad FE, Ovreness T, Nordbo SA. [Chlamydia trachomatis--pattern of testing and prevalence among young women]. Tidsskr Nor Laegeforen. 2004 Jun 17;124(12):1636-7. Norwegian.

  PMID: 15229709 BACKGROUND

• Bakken IJ, Skjeldestad FE, Nordbo SA. [Chlamydia trachomatis infection in women seeking termination of pregnancy 1985-2000]. Tidsskr Nor Laegeforen. 2004 Jun 17;124(12):1638-40. Norwegian.

  PMID: 15229710 BACKGROUND

• 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: 11807700 BACKGROUND

• van Bergen J, Gotz HM, Richardus JH, Hoebe CJ, Broer J, Coenen AJ; PILOT CT study group. Prevalence of urogenital Chlamydia trachomatis increases significantly with level of urbanisation and suggests targeted screening approaches: results from the first national population based study in the Netherlands. Sex Transm Infect. 2005 Feb;81(1):17-23. doi: 10.1136/sti.2004.010173.

  PMID: 15681716 BACKGROUND

• Van Der Pol B, Ferrero DV, Buck-Barrington L, Hook E 3rd, Lenderman C, Quinn T, Gaydos CA, Lovchik J, Schachter J, Moncada J, Hall G, Tuohy MJ, Jones RB. Multicenter evaluation of the BDProbeTec ET System for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens, female endocervical swabs, and male urethral swabs. J Clin Microbiol. 2001 Mar;39(3):1008-16. doi: 10.1128/JCM.39.3.1008-1016.2001.

  PMID: 11230419 BACKGROUND

• Klovstad H, Natas O, Tverdal A, Aavitsland P. Systematic screening with information and home sampling for genital Chlamydia trachomatis infections in young men and women in Norway: a randomized controlled trial. BMC Infect Dis. 2013 Jan 23;13:30. doi: 10.1186/1471-2334-13-30.

  PMID: 23343391 DERIVED

MeSH Terms

Interventions

Urinalysis

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Preben Aavitsland, MD

  NIPH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 26, 2006
• First Posted: January 27, 2006
• Study Start: February 1, 2006
• Study Completion: September 1, 2006
• Last Updated: March 3, 2010

Record last verified: 2009-01

Locations

NO (1)