HIV Indicator Diseases Survey Across Europe - UK Arm

NCT ID: NCT01196468

Last Updated: 2012-04-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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HIV AIDS Indicator Diseases/Indicator Conditions

Study Design

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Study Time Perspective

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)

Intervention Type OTHER

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

Interview

Intervention Type OTHER

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)

Intervention Type OTHER

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

Interview

Intervention Type OTHER

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)

Intervention Type OTHER

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

Interview

Intervention Type OTHER

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)

Intervention Type OTHER

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

Interview

Intervention Type OTHER

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)

Intervention Type OTHER

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

Interview

Intervention Type OTHER

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HIV in Europe (Co-Sponsor)

UNKNOWN

Sponsor Role collaborator

Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Ann K Sullivan, MBBS FRCP

Role: CONTACT

+44 (0)208 746 8000 ext. 56199

Michael Rayment, MBBS MA MRCP

Role: CONTACT

+44 (0)208 746 8000 ext. 56529

Other Identifiers

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Indicator Diseases Survey

Identifier Type: -

Identifier Source: org_study_id

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