Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2010-07-31
2014-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CROSS_SECTIONAL
Study Groups
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Anal/cervical dyplasia
Any patient presenting for care with any degree of anal or cervical dysplasia
HIV test (serological or salivary)
An HIV test will be offered to all patients accessing the healthcare setting for care of the "indicator" condition
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
STI
Any patient presenting for care with any non-HIV sexually transmitted infection
HIV test (serological or salivary)
An HIV test will be offered to all patients accessing the healthcare setting for care of the "indicator" condition
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
Lymphoma
Any patient presenting for care with malignant lymphoma of any histological type
HIV test (serological or salivary)
An HIV test will be offered to all patients accessing the healthcare setting for care of the "indicator" condition
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
Seborrhoeic dermatitis/exanthema
Any patient presenting for care with seborrhoeic dermatitis/exanthema
HIV test (serological or salivary)
An HIV test will be offered to all patients accessing the healthcare setting for care of the "indicator" condition
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
Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia
Any patient presenting for care with unexplained thromobocytopaenia/leucopaenia of more than four weeks duration, or with hypergammaglobulinaemia
HIV test (serological or salivary)
An HIV test will be offered to all patients accessing the healthcare setting for care of the "indicator" condition
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
Interventions
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HIV test (serological or salivary)
An HIV test will be offered to all patients accessing the healthcare setting for care of the "indicator" condition
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
Eligibility Criteria
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Inclusion Criteria
* 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
* sub-study - declines to consent for additional information to be collected
16 Years
ALL
No
Sponsors
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HIV in Europe (Co-Sponsor)
UNKNOWN
Chelsea and Westminster NHS Foundation Trust
OTHER
Responsible Party
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Chelsea and Westminster NHS Foundation Trust, London, UK
Principal Investigators
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Ann K Sullivan, MBBS FRCP
Role: PRINCIPAL_INVESTIGATOR
Chelsea and Westminster NHS Foundation Trust
Jens Lundgren, MBBS
Role: STUDY_DIRECTOR
University of Copenhagen and Righospitalet
David Cunningham, PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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Chelsea and Westminster NHS Foundation Trust
London, , United Kingdom
Royal Marsden NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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Indicator Diseases Survey
Identifier Type: -
Identifier Source: org_study_id
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