CClinicalTrials.gg
Status unknownNCT01681706HIDESUpdated Sep 10, 2012

HIV Indicator Diseases Across Europe Study

An observational study in HIV, sponsored by Jesper Grarup. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2012-09-10.

Sponsored by Jesper Grarup · Observational

The sponsor has not verified this record recently (last verified Sep 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
14,000
Ages
18 Years to 64 Years
Sex
All
01

Study summary

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)
Read the 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

02

Conditions studied

  • HIV

Keywords

  • HIV
  • Indicator disease
03

In context

Lead sponsor

This is the only study on the registry with Jesper Grarup as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Known HIV positive
05

Study design

Time perspective
Prospective
Enrollment
14,000 participants (estimated)
06

What researchers measure

Primary outcomes

  1. Prevalence of HIV

    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.

    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

07

Study locations

1 of 1 sites recruiting
  • University of Copenhagen, Panum Institute, Health faculty,
    Copenhagen, 2100, Denmark
    • Dorthe Raben · Contact · dra@cphiv.dk · 0045 3545 5757
    • Jens Lundgren, Professor · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01681706
Lead sponsor
Jesper Grarup
Responsible party
Jesper Grarup (Director of Administration, University of Copenhagen) — Sponsor-investigator
First posted
Sep 10, 2012
Start date
Feb 2012
Primary completion
Dec 2013 (estimated)
Completion
Jun 2014 (estimated)
Last update
Sep 10, 2012

Study contacts

Dorthe Raben
Contact
dra@cphiv.dk
0045 3545 5757 ext. 5782
Jens D Lundgren, Prof.
principal investigator · University of Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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