Clinical trial NCT00283127: Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women.
Official title: Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women. - A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia Trachomatis
Mass Screening
Keywords: Chlamydia trachomatis
Mass screening
Home sampling
Urine test
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
First posted: 2006-01-27
Enrollment: 41719
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Yield ratio tested for uro-genital C.trachomatis infection
measure: Yield ratio diagnosed for uro-genital C.trachomatis infection
measure: Yield ratio treated for uro-genital C.trachomatis infection
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegain Institute of Public Health
Study officials:
affiliation: NIPH
name: Preben Aavitsland, MD
role: STUDY_DIRECTOR
References:
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citation: 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.
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citation: 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.
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. doi: 10.1128/JCM.39.3.1008-1016.2001.
citation: 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.