HIV Indicator Diseases Survey Across Europe - UK Arm

NCT01196468 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2012-04-12

No results posted yet for this study

Summary

In Europe many patients infected with HIV remain undiagnosed, although this percentage varies between 15-80% across the continent. In the UK it is estimated to be 27%. Undiagnosed HIV results in increased morbidity and mortality and reduced treatment response, as appropriate health interventions are delayed. It also has adverse public health implications, with those individuals unaware of their HIV status being more likely to transmit the virus.

An important public health issue is how to diagnose more individuals with HIV earlier in the course of their infection. In the US, the Centre for Disease Control and Prevention (CDC) has introduced testing guidelines whereby all individuals are tested, unless they object, at any point of contact with the healthcare system - the "opt-out" testing guidelines.

At the "HIV in Europe" Conference held in November 2007, the consensus, which included patient and public involvement, was that such an approach would not be suitable for Europe. The Conference recommended further development of focused HIV testing in patients presenting with certain clinical conditions and diseases - the "indicator disease'' testing guidelines.

Cost effectiveness analyses suggests cost savings if a screened population has an HIV prevalence of at least 1%, although this rate may be as low as 0.1%. However, there is very little - if any - evidence regarding HIV prevalence for certain conditions and diseases in specific and easy to identify sections of society. The focus of attention is on those conditions and diseases which occur more frequently in individuals known to be infected with HIV.

The aim of this study is to assess HIV prevalence for several diseases and conditions, within a specific segment of the population not yet diagnosed with HIV, who present for care with that specific disease or condition. These conditions have been selected as they occur frequently in individuals already diagnosed with HIV infection. This is a pilot study to inform phase two, which will involve more diseases and conditions with a wider participation of centres across Europe.

Conditions

  • HIV
  • AIDS
  • Indicator Diseases/Indicator Conditions

Interventions

OTHER

HIV test (serological or salivary)

An HIV test will be offered to all patients accessing the healthcare setting for care of the "indicator" condition

OTHER

Interview

Demographic data will be collected for each patient consenting to an HIV test. With informed written consent, additional data will be collected from patients via focussed interview. Data comprises: previous medical history, previous health seeking behaviours, previous HIV testing history, previous viral hepatitis testing/diagnosis history, and assessment of HIV acquisition risk factors

Sponsors & Collaborators

  • HIV in Europe (Co-Sponsor)

    collaborator UNKNOWN
  • Chelsea and Westminster NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ann K Sullivan, MBBS FRCP · Chelsea and Westminster NHS Foundation Trust

  • Jens Lundgren, MBBS · University of Copenhagen and Righospitalet

  • David Cunningham, PhD FRCP · Royal Marsden NHS Foundation Trust

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-07-31
Completion
2014-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01196468 on ClinicalTrials.gov