NCT00973466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 13, 2011

Status Verified

January 1, 2011

Enrollment Period

1 year

First QC Date

September 4, 2009

Last Update Submit

January 12, 2011

Conditions

HIV InfectionsNeisseria GonorrhoeaeChlamydia TrachomatisHerpes Simplex

Keywords

HIV-infectionNeisseria gonorrheaChlamydia trachomatisHerpes simplex virusprevalence

Outcome Measures

Primary Outcomes (1)

  • Prevalence of infection with C.trachomatis, N. gonorrhea and Seroprevalence of HSV 2 infection

    6 months

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • HIV-infection
  • Attending the Clinic for Infectious Diseases from May 09 to November 09
  • Sexually active during the last 12 months
  • Written informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Infectious Diseases, Berne University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

HIV InfectionsHerpes SimplexAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHerpesviridae InfectionsDNA Virus InfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesSlow Virus Diseases

Study Officials

  • Hansjakob Furrer, MD

    University Hospital Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2009

First Posted

September 9, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

January 13, 2011

Record last verified: 2011-01

Locations

CH(1)