Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women.
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.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Chlamydia Trachomatis
Intervention
Home sampling (urine test) for uro-genital C.trachomatis.
Location
Norwegain Institute of Public Health
Oslo
Norway
0403
Status
Completed
Source
Norwegian Institute of Public Health
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00283127
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Chlamydia Muridarum
Species of CHLAMYDIA causing pneumonitis in mice and hamsters. These isolates formerly belonged to CHLAMYDIA TRACHOMATIS.
Chlamydia Trachomatis
Type species of CHLAMYDIA causing a variety of ocular and urogenital diseases.
Chlamydia
A genus of the family CHLAMYDIACEAE whose species cause a variety of diseases in vertebrates including humans, mice, and swine. Chlamydia species are gram-negative and produce glycogen. The type species is CHLAMYDIA TRACHOMATIS.
Trachoma
A chronic infection of the CONJUNCTIVA and CORNEA caused by CHLAMYDIA TRACHOMATIS.
Chlamydophila
A genus of the family CHLAMYDIACEAE comprising gram-negative non CHLAMYDIA TRACHOMATIS-like species infecting vertebrates. Chlamydophila do not produce detectable quantities of glycogen. The type species is CHLAMYDOPHILA PSITTACI.
Clinical Trials
Immunopathogenesis of Chlamydia
Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic...
Home Screening for Chlamydia Surveillance
This is a randomized controlled trial to determine whether a home screening test for chlamydia and gonorrhea will lead to increased use of screening tests and increased detection of sexual...
Chlamydia Trachomatis Immunology and Vaccinology Study
The primary objective is to prospectively follow 200 women with or at risk of cervicitis to determine the chlamydia-specific cellular responses that correlate with protection against incid...
Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin
Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, f...
Antigen-Specific Cell Mediated Immune Response to Chlamydia Trachomatis
This is an exploratory study in which the investigators will develop a way to identify the cell responses most strongly associated with protection against chlamydia infection. This study...
PubMed Articles
ABSTRACT: BACKGROUND: We assessed the feasibility of collecting urine samples for testing on genital Chlamydia trachomatis infection in a population-based survey, and prevalence of this infection amon...
How to Detect Chlamydia trachomatis in Males?
Much is known about the role of Chlamydia trachomatis in female infertility, although the same cannot be said about the organism's role in male infertility. Recently, a number of workers have provided...
Chlamydia trachomatis and placental inflammation in early preterm delivery.
Chlamydia trachomatis may infect the placenta and subsequently lead to preterm delivery. Our aim was to evaluate the relationship between the presence of Chlamydia trachomatis and signs of placental i...
Objectives To investigate the performance of the fully automated cobas 4800 CT/NG test for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Methods The study was conducted using 900 clini...
The value of testing semen for Chlamydia trachomatis in men of infertile couples.
Summary Chlamydia trachomatis is an important bacterial cause of infertility. In men, the recommended specimen for diagnosing chlamydial infection is urine, with little or no emphasis placed on testin...
