Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women.
Condition: Chlamydia Trachomatis; Mass Screening
MeSH terms: Chlamydia Infections
Study type: Interventional

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.
    

Intervention name(s): Home sampling (urine test) for uro-genital C.trachomatis.
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chlamydia trachomatis; Mass screening; Home sampling; Urine test