Trial record 12 of 35 for:    mononucleosis

HIV Indicator Diseases Across Europe Study (HIDES)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jesper Grarup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01681706
First received: August 28, 2012
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

The purpose of this non-interventional study is to implement a survey initiative to assess HIV prevalence for one or more diseases and/or conditions within a specific segment of the population not yet diagnosed with HIV, who presents for care with the specific disease/condition.

The list of diseases below is not indicative of the most important indicator diseases for HIV but rather a list of diseases suggested for surveillance.

This study will enrol patients presenting with the following diseases/conditions:

  1. Presenting for care of malignant lymphoma, irrespective of type
  2. Presenting for care of cervical or anal dysplasia or cancer, (Cervical CIN II and above)
  3. Presenting for care of Hepatitis B or C virus infection (acute or chronic - and irrespective of time of diagnosis relative to time of survey),
  4. Presenting with ongoing mononucleosis-like illness
  5. Presenting with unexplained leukocytopenia or thrombocytopenia lasting at least 4 weeks
  6. Presenting with seborrheic dermatitis / exanthema
  7. Presenting with pneumonia, admitted to hospital for at least 24h
  8. Presenting with unexplained lymphadenopathy
  9. Presenting with peripheral neuropathy of unknown cause (diagnosed by neurologist)
  10. Presenting with primary lung cancer
  11. Presenting with severe or recalcitrant psoriasis (newly diagnosed)

Condition
HIV

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: HIV Indicator Diseases Across Europe Study

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Prevalence of HIV [ Time Frame: Participants are surveyed once up to month 23 for presenting indicator disease and result of the HIV test performed. Per site 100 participants are included in each survey - in total the single survey requires minimum 400 participants from all sites ] [ Designated as safety issue: No ]
    To assess the HIV prevalence for the identified diseases and/or conditions within a specific segment of the population not yet diagnosed with HIV and that present for care with the specific disease/condition.


Estimated Enrollment: 14000
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Most patients infected with HIV across the European continent remain undiagnosed; although this percentage varies markedly from 15-80% across the continent. Undiagnosed HIV is harmful to the person infected as appropriate health interventions are then delayed until the HIV infection is diagnosed. It is also detrimental to society as persons unaware of their HIV infection may transmit more frequently to others than persons that are aware of their HIV status.

An important public health issue is hence how to diagnose more HIV-infected persons earlier in the course of their infection. In the US, the Centers for Disease Control and Prevention (CDC) has introduced testing guidelines where all persons are tested upon entry into the hospital system (the "opt-out" testing guidelines).

At the "HIV in Europe" conference held in November 2007, the general sense was that such an approach would not be suitable for Europe. Conversely, the conference recommended further development of focused HIV testing in patients presenting with certain clinical conditions and/or diseases (i.e. indicator condition guided testing).

Cost effectiveness analyses suggests cost savings if a population with a HIV prevalence of 1% or more are tested although this rate may be as low as 0.1%. However, there is very little - if any - evidence on HIV prevalence for various conditions and diseases in specific and easy to identify sections of society. This is true in general and particularly across the European continent.

Surveys will be undertaken by the investigators:

Zangerle, Kitchen, U H Innsbruck, Vassilenko, Minsk Municipal Infectious Diseases Hospital, Necsoi, Clumeck, Saint-Pierre U H Hadziosmanovic, U of Sarajevo Begovac, U Hospital of Infectious Diseases Pedersen, Mogensen, Abildgaard, Titlestad, Odense U H Dragsted, Roskilde H Späth, U of Bonn Sthoeger, Neve-Or AIDS Centre d'Armino Monforte, Mareo, Comi, Centanni, San Paolo H Grzeszczuk, Medical U of Bialystok Maltez, H Curry Cabral Castro, HU A Coruna-Hospital Juan Canalejo Masia, HU Elche Estrada, HCU San Carlos Iribarren, H. Donostia Ortega, CH General de Valencia Ocampo, H Xeral-Cies Vernazza, Kantonsspital St. Gallen Perry, Fisher, Elton John Centre, Morris, RIDU Minton, St James's U H Palfreeman, Leicester Royal Infirmary Gazzard, Sullivan, ChelseaWestminster H Winston, Walsh, St Mary's H Anderson, Millett, Homerton H NHS Trust Farazmand, Huddersfield Royal Infirmary Ong, Krasnov, Kharkov Regional Clinic of Infectious Diseases Kutsyna, State Medical U

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants between the age of 18 and 64 years old, presenting with 1 of the 11 indicator diseases surveyed

Criteria

Inclusion Criteria:

  • HIV status unknown
  • Presenting for care with 1 of the 11 indicator diseases surveyed.

Exclusion Criteria:

  • Known HIV positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681706

Contacts
Contact: Dorthe Raben 0045 3545 5757 ext 5782 dra@cphiv.dk

Locations
Denmark
University of Copenhagen, Panum Institute, Health faculty, Recruiting
Copenhagen, Denmark, 2100
Contact: Dorthe Raben    0045 3545 5757 ext 5782    dra@cphiv.dk   
Principal Investigator: Jens Lundgren, Professor         
Sponsors and Collaborators
Jesper Grarup
Investigators
Principal Investigator: Jens D Lundgren, Prof. University of Copenhagen
  More Information

No publications provided

Responsible Party: Jesper Grarup, Director of Administration, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01681706     History of Changes
Other Study ID Numbers: HIDES
Study First Received: August 28, 2012
Last Updated: September 5, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
HIV
Indicator disease

ClinicalTrials.gov processed this record on October 23, 2014