HIV Indicator Diseases Survey Across Europe - UK Arm

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Chelsea and Westminster NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
HIV in Europe (Co-Sponsor)
Information provided by:
Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01196468
First received: August 10, 2010
Last updated: April 11, 2012
Last verified: October 2009

August 10, 2010
April 11, 2012
July 2010
July 2011   (final data collection date for primary outcome measure)
Prevalence of HIV infection in patients presenting to specific services with specific HIV indicator diseases [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01196468 on ClinicalTrials.gov Archive Site
  • Previous HIV testing behaviour of individuals presenting with an indicator disease or condition (sub-study only) [ Designated as safety issue: No ]
    Any previous history of HIV tests taken: total number, dates, and results
  • Demographic data of individuals presenting for care with specified indicator diseases [ Designated as safety issue: No ]
    Data comprise: age group, sex, ethnicity (plus sexuality and injecting drug use history for sub-study participants only)
  • Time to transfer to care for those individuals testing HIV positive [ Designated as safety issue: No ]
  • Immune status of newly-diagnosed HIV positive individuals as determined by CD4 cell count [ Designated as safety issue: No ]
  • HIV risk factors (sub-study only) [ Designated as safety issue: No ]
  • Previous medical history and health-seeking behaviour (sub-study only) [ Designated as safety issue: No ]
    Past medical history will be recorded, with particular attention paid to previous illnesses that constitute AIDS-defining illnesses, or other severe, non-AIDS infections and cancers. Number of visits to primary care and any inpatient admissions over preceding five years will be recorded.
Same as current
Not Provided
Not Provided
 
HIV Indicator Diseases Survey Across Europe - UK Arm
HIV Indicator Diseases Survey Across Europe

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.

Not Provided
Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   None Retained
Description:

Salivary or serological HIV test

Non-Probability Sample

Adults (16 years and over), not known already to be HIV-positive, presenting for care in designated healthcare settings with one of five "indicator diseases." Sequential patients will be offered HIV tests, and if they accept, asked to provide additional information via focussed interview (sub-study).

  • HIV
  • AIDS
  • Indicator Diseases/Indicator Conditions
  • 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
  • Anal/cervical dyplasia
    Any patient presenting for care with any degree of anal or cervical dysplasia
    Interventions:
    • Other: HIV test (serological or salivary)
    • Other: Interview
  • STI
    Any patient presenting for care with any non-HIV sexually transmitted infection
    Interventions:
    • Other: HIV test (serological or salivary)
    • Other: Interview
  • Lymphoma
    Any patient presenting for care with malignant lymphoma of any histological type
    Interventions:
    • Other: HIV test (serological or salivary)
    • Other: Interview
  • Seborrhoeic dermatitis/exanthema
    Any patient presenting for care with seborrhoeic dermatitis/exanthema
    Interventions:
    • Other: HIV test (serological or salivary)
    • Other: Interview
  • Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia
    Any patient presenting for care with unexplained thromobocytopaenia/leucopaenia of more than four weeks duration, or with hypergammaglobulinaemia
    Interventions:
    • Other: HIV test (serological or salivary)
    • Other: Interview
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
February 2014
July 2011   (final data collection date for primary outcome measure)

Inclusion criteria

  • Aged 16 years and over
  • Presenting for care with one of the indicator diseases or conditions:

    • A sexually transmitted disease
    • Malignant lymphoma
    • Cervical or anal dysplasia or cancer
    • Unexplained leukocytopenia or thrombocytopenia lasting at least 4 weeks, or hypergammaglobulinaemia
    • Seborrheic dermatitis or exanthema
  • sub-study - consents to providing additional information

Exclusion criteria

  • Known HIV positive
  • sub-study - declines to consent for additional information to be collected
Both
16 Years and older
No
Contact: Ann K Sullivan, MBBS FRCP +44 (0)208 746 8000 ext 56199 ann.sullivan@chelwest.nhs.uk
Contact: Michael Rayment, MBBS MA MRCP +44 (0)208 746 8000 ext 56529 michaelrayment@nhs.net
United Kingdom
 
NCT01196468
Indicator Diseases Survey
Yes
Dr Ann Sullivan, Chelsea and Westminster NHS Foundation Trust, London, UK
Chelsea and Westminster NHS Foundation Trust
HIV in Europe (Co-Sponsor)
Principal Investigator: Ann K Sullivan, MBBS FRCP Chelsea and Westminster NHS Foundation Trust
Study Director: Jens Lundgren, MBBS University of Copenhagen and Righospitalet
Principal Investigator: David Cunningham, PhD FRCP Royal Marsden NHS Foundation Trust
Chelsea and Westminster NHS Foundation Trust
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP