Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283127
Status:
COMPLETED
Last Update Posted:
2010-03-03
First Post:
2006-01-26
Brief Title:
Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women
Sponsor:
Norwegian Institute of Public Health
Organization:
Norwegian Institute of Public Health
Study Overview
Official Title:
Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women - A Randomised Control Trial
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urogenital Chlamydia trachomatis infection is the most common bacterial sexually transmitted infection in Norway Urogential Ctrachomatis 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 untreatedWe 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 doctors office control in identifying men and women aged 18-25 years with urogenital Ctrachomatis infection Part A We also want to identify factors influencing the acceptability of home sampling for Ctrachomatis infections Part Band determine factors associated with Ctrachomatis 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 Ctrachomatis 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 groupThe 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 samplesurethral or cervical swabs or urine samplestaken 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 physicians 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 Crachomatis within one month after after a positive Ctrachomatis 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 RatioPR of urogential Ctrachomatis infections associated with different factors by comparing Ctrachomatis positive and Ctrachomatis negative in the intervention group
Part D is an economic study which will be addressed in a separate protocol
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 Ctrachomatis 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 groupThe 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 samplesurethral or cervical swabs or urine samplestaken 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 physicians 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 Crachomatis within one month after after a positive Ctrachomatis 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 RatioPR of urogential Ctrachomatis infections associated with different factors by comparing Ctrachomatis positive and Ctrachomatis negative in the intervention group
Part D is an economic study which will be addressed in a separate protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None