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

Chlamydia Trachomatis Clinical Trial

Official title:

Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women. - A Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283127
• Other study ID #: 2.2005.1223
• Status: Completed
• Phase: N/A
• First received: January 26, 2006
• Last updated: March 2, 2010
• Start date: February 2006
• Est. completion date: September 2006

Study information

• Verified date: January 2009
• Source: Norwegian Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: The Data InspectorateNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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).

Description:

Study design The different objectives will be addressed through a complex design with several sub-studies.

Part A is a randomised control trial where we compare the intervention group who will be offered home-sampling and recieve a package by mail (containing information on urogenital C.trachomatis infections, sampling eqiupment for urine tests and a questionnaire) with a control group who will continue with todays system of conventional sampling at the doctores office (no intervention). The study population are all men and women between 18-25 years of age in Rogaland County in Norway. The population register will be used to randomly assigne to either the intervention group or the control group.The intervention group will be asked to take a urine sample and send this by mail to the laboratory for analysis within three months after the invitation, and to fill out and return a questionnaire. For the ones in the control group all samples(urethral or cervical swabs or urine samples)taken within the same three months will be sendt to the same laboratory. In this part of the study we will measure the yield ratio for the tested, diagnosed and treated in the two groupsafter the study period of three months. All samples either obtained at home or at the physician's office, will be analyzed by BDProbeTec ET Chlamydia Amplified DNA assay. This is a well documented Nucleid Acid amplification method. Samples will be analysed according to manufactures instructions. Data on number of tested and diagnosed in the two groups will be collected from Stvanger University Hospital. Data on number of treated will be collected from the Norwegain Prescription Database by merging the study dataset with their datafiles. This way we will recive information on who has received treatment for C.rachomatis within one month after after a positive C.trachomatis test.

In Part B a case-cohort from the intervention group (Part A) consisting of a random selection of respondents and non-respondents will be used to determine the feasibility of home sampling as a screening strategy by measuring the risk (OR) related to different factors that determined response. Data are collected through selfadminitered questionnaires.

Part C is a cross sectional study consisting of all respondents in the intervention group. In this part we will measure Prevalence Ratio(PR) of urogential C.trachomatis infections associated with different factors by comparing C.trachomatis positive and C.trachomatis negative in the intervention group.

Part D is an economic study which will be addressed in a separate protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41719
• Est. completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis
• Mass Screening

Intervention

Procedure:
• Home sampling (urine test) for uro-genital C.trachomatis.

Locations

Country	Name	City	State
Norway	Norwegain Institute of Public Health	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian Institute of Public Health

Country where clinical trial is conducted

Norway, 

References & Publications (6)

Andersen B, Olesen F, Møller JK, Østergaard 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. Epub 2002 Jan 3. — View Citation

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

Schachter J. Chlamydial infections. West J Med. 1990 Nov;153(5):523-34. Review. — View Citation

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

van Bergen J, Götz 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yield ratio tested for uro-genital C.trachomatis infection
Primary	Yield ratio diagnosed for uro-genital C.trachomatis infection
Primary	Yield ratio treated for uro-genital C.trachomatis infection