Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients (CTNG)
| Tracking Information | |||||
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| First Received Date ICMJE | September 4, 2009 | ||||
| Last Updated Date | January 12, 2011 | ||||
| Start Date ICMJE | May 2009 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prevalence of infection with C.trachomatis, N. gonorrhea and Seroprevalence of HSV 2 infection [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00973466 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients | ||||
| Official Title ICMJE | Prevalence of Asymptomatic and Symptomatic Infection of N. Gonorrheae and C. Trachomatis and Seroprevalence of HSV Typ 2 and Sexual Health Seeking Behaviour in People With HIV Infection in Bern | ||||
| Brief Summary | There has been an increase in incidence in sexually transmitted infections in HIV infected patients in the last years. In this study the investigators will prospectively evaluate the prevalence of symptomatic and asymptomatic infections with N. gonorrhea and Ch. trachomatis as well as the seroprevalence of Herpes simplex Type 2 infection in HIV-infected patients attending the clinic for infectious diseases at the Berne University Hospital. In addition, participants will be asked to fill out a questionnaire on sexual behaviour and sexual health. Study hypothesis: STI prevalence is high in certain risk-groups to justify screening in regular intervals. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | All consecutive HIV-infected patients attending the Clinic for Infectious Diseases at Bern University Hospital will be asked to participate in the study if they were sexually active during the last 12 months |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | HIV-infection
All HIV-infected patients attending the Clinic for Infectious Diseases at Berne university hospital, having been sexually active during the past 12 months and having given written informed consent |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00973466 | ||||
| Other Study ID Numbers ICMJE | KEK26/09 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hansjakob Furrer, Leitender Arzt, University Hospital Inselspital, Berne | ||||
| Study Sponsor ICMJE | University Hospital Inselspital, Berne | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital Inselspital, Berne | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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