Chlamydia Trachomatis Clinical Trial
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).
Status | Completed |
Enrollment | 41719 |
Est. completion date | September 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 25 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Norway | Norwegain Institute of Public Health | Oslo |
Lead Sponsor | Collaborator |
---|---|
Norwegian Institute of Public Health |
Norway,
Andersen B, Olesen F, Møller JK, Østergaard 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. Epub 2002 Jan 3. — View Citation
Bakken IJ, Skjeldestad FE, Nordbø SA. [Chlamydia trachomatis infection in women seeking termination of pregnancy 1985-2000]. Tidsskr Nor Laegeforen. 2004 Jun 17;124(12):1638-40. Norwegian. — View Citation
Schachter J. Chlamydial infections. West J Med. 1990 Nov;153(5):523-34. Review. — View Citation
Strand RH, Skjeldestad FE, Øvreness T, Nordbø SA. [Chlamydia trachomatis--pattern of testing and prevalence among young women]. Tidsskr Nor Laegeforen. 2004 Jun 17;124(12):1636-7. Norwegian. — View Citation
van Bergen J, Götz 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Yield ratio tested for uro-genital C.trachomatis infection | |||
Primary | Yield ratio diagnosed for uro-genital C.trachomatis infection | |||
Primary | Yield ratio treated for uro-genital C.trachomatis infection |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03676816 -
Self Sampling for Rapid Turnaround Testing in the Emergency Department
|
N/A | |
Completed |
NCT00213018 -
Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
|
Phase 2 | |
Completed |
NCT00827970 -
Randomized Population-Based Study on Chlamydia Trachomatis Screening
|
N/A | |
Withdrawn |
NCT01358799 -
Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System
|
N/A | |
Completed |
NCT01733069 -
Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
|
N/A | |
Completed |
NCT00978848 -
Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing
|
N/A | |
Completed |
NCT02391233 -
Multimedia WORTH With Black Drug-Involved Women on Probation
|
N/A | |
Completed |
NCT00973466 -
Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients
|
N/A | |
Completed |
NCT03071510 -
Evaluation of the Atlas Genetics io® CTNG System
|
||
Recruiting |
NCT04446611 -
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes
|
N/A | |
Completed |
NCT01329588 -
Periodical Presumptive Treatment for the Control of Gonococcal Infections Among Sex Workers
|
Phase 4 | |
Not yet recruiting |
NCT06216964 -
Time to Clearance of Chlamydia Trachomatis and Neisseria Gonorrhoeae RNA After Treatment: a Prospective Cohort Study
|
N/A | |
Terminated |
NCT02795975 -
Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples
|
N/A | |
Completed |
NCT00213057 -
Safety and Acceptability of Carraguard™ Among HIV-negative Couples in Thailand
|
Phase 1 | |
Completed |
NCT00207454 -
Optimizing Strategies to Improve STD Partner Services
|
Phase 1 | |
Completed |
NCT00177437 -
Home Screening for Chlamydia Surveillance
|
Phase 3 | |
Completed |
NCT02787109 -
Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years
|
Phase 1 | |
Completed |
NCT01665690 -
Washington State Community Expedited Partner Treatment (EPT) Trial
|
Phase 4 | |
Completed |
NCT02128620 -
A Randomized Online Health Experiment for a Safer Youth Sexual Behaviour
|
N/A | |
Completed |
NCT00618449 -
Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
|
Phase 4 |