Chlamydia TrachomatisNCT00283127
Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women.
A study testing Home sampling (urine test) for uro-genital C.trachomatis. in people with Chlamydia Trachomatis and Mass Screening, run by Norwegian Institute of Public Health at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis, Mass Screening
- What is being tested?
- Home sampling (urine test) for uro-genital C.trachomatis.
- Type of treatment
- Surgery or procedure
- How many people
- 41,719 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2006to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women. - A Randomised Control Trial
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).
Read the 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.
- Conditions
- Chlamydia Trachomatis, Mass Screening
- Being tested
- Home sampling (urine test) for uro-genital C.trachomatis.
- Keywords
- Chlamydia trachomatis, Mass screening, Home sampling, Urine test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home sampling (urine test) for uro-genital C.trachomatis.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield ratio tested for uro-genital C.trachomatis infection
Yield ratio diagnosed for uro-genital C.trachomatis infection
Yield ratio treated for uro-genital C.trachomatis infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startFeb 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chlamydia TrachomatisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41,719 participants
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Investigators
- Preben Aavitsland, MD, Study director, NIPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283127
- Sponsor's protocol ID
- 2.2005.1223
- Status last verified
- Jan 2009
- First submitted
- 26 Jan 2006
- Last updated
- 3 Mar 2010
- Results posted
- No
Publications
Schachter J. Chlamydial infections. West J Med. 1990 Nov;153(5):523-34. No abstract available.
PubMed 2260289Strand RH, Skjeldestad FE, Ovreness T, Nordbo SA. [Chlamydia trachomatis--pattern of testing and prevalence among young women]. Tidsskr Nor Laegeforen. 2004 Jun 17;124(12):1636-7. Norwegian.
PubMed 15229709Bakken 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.
PubMed 15229710Andersen B, Olesen F, Moller JK, Ostergaard 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. doi: 10.1086/338268. Epub 2002 Jan 3.
PubMed 11807700van 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.
PubMed 15681716Van 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.
PubMed 11230419Klovstad 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.
PubMed 23343391
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Sampling Versus Conventional Sampling for Screening of Urogenital Chlamydia Trachomatis in Young Men and Women. - A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT00283127
- Acronym / sponsor ID
- 2.2005.1223
- Conditions
- Chlamydia Trachomatis, Mass Screening
- Keywords
- Chlamydia trachomatis, Mass screening, Home sampling, Urine test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41,719 participants
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Study start
- Feb 2006
- Study completion
- Sep 2006
- First posted
- 27 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- All persons in the population register in Rogaland born between 1/1-1980 - 31/12 -1987 registered as:
- In total 78 persons were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home sampling (urine test) for uro-genital C.trachomatis. | Procedure or surgery | – |
Primary outcome
Yield ratio tested for uro-genital C.trachomatis infection
Yield ratio diagnosed for uro-genital C.trachomatis infection
Yield ratio treated for uro-genital C.trachomatis infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2010.
- Background: PubMed 2260289Schachter J. Chlamydial infections. West J Med. 1990 Nov;153(5):523-34. No abstract available.
- Background: PubMed 15229709Strand RH, Skjeldestad FE, Ovreness T, Nordbo SA. [Chlamydia trachomatis--pattern of testing and prevalence among young women]. Tidsskr Nor Laegeforen. 2004 Jun 17;124(12):1636-7. Norwegian.
- Background: PubMed 15229710Bakken 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.
- Background: PubMed 11807700Andersen B, Olesen F, Moller JK, Ostergaard 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. doi: 10.1086/338268. Epub 2002 Jan 3.
- Background: PubMed 15681716van 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.
- Background: PubMed 11230419Van 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.
- Derived from this study: PubMed 23343391Klovstad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preben Aavitsland, MD study director
NIPH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home sampling (urine test) for uro-genital C.trachomatis. in people with Chlamydia Trachomatis and Mass Screening, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yield ratio tested for uro-genital C.trachomatis infection. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00283127, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2010.