HIV Indicator Diseases Survey Across Europe - UK Arm

Study Overview
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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.

Official Title
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HIV Indicator Diseases Survey Across Europe

Conditions
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HIV, AIDS, Indicator Diseases/Indicator Conditions

Intervention / Treatment
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* Other: HIV test (serological or salivary)
* Other: Interview


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anal/cervical dyplasia<br>Any patient presenting for care with any degree of anal or cervical dysplasia | Other: HIV test (serological or salivary)<br>* An HIV test will be offered to all patients accessing the healthcare setting for care of the indicator condition<br>Other: Interview<br>* 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<br>|
| STI<br>Any patient presenting for care with any non-HIV sexually transmitted infection | Other: HIV test (serological or salivary)<br>* An HIV test will be offered to all patients accessing the healthcare setting for care of the indicator condition<br>Other: Interview<br>* 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<br>|
| Lymphoma<br>Any patient presenting for care with malignant lymphoma of any histological type | Other: HIV test (serological or salivary)<br>* An HIV test will be offered to all patients accessing the healthcare setting for care of the indicator condition<br>Other: Interview<br>* 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<br>|
| Seborrhoeic dermatitis/exanthema<br>Any patient presenting for care with seborrhoeic dermatitis/exanthema | Other: HIV test (serological or salivary)<br>* An HIV test will be offered to all patients accessing the healthcare setting for care of the indicator condition<br>Other: Interview<br>* 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<br>|
| Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia<br>Any patient presenting for care with unexplained thromobocytopaenia/leucopaenia of more than four weeks duration, or with hypergammaglobulinaemia | Other: HIV test (serological or salivary)<br>* An HIV test will be offered to all patients accessing the healthcare setting for care of the indicator condition<br>Other: Interview<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of HIV infection in patients presenting to specific services with specific HIV indicator diseases |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Previous HIV testing behaviour of individuals presenting with an indicator disease or condition (sub-study only) | Any previous history of HIV tests taken: total number, dates, and results |  | 
| Demographic data of individuals presenting for care with specified indicator diseases | 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 |  |  | 
| Immune status of newly-diagnosed HIV positive individuals as determined by CD4 cell count |  |  | 
| HIV risk factors (sub-study only) |  |  | 
| Previous medical history and health-seeking behaviour (sub-study only) | 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. |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Testing, Targeted, Indicator, Diseases, Anal dysplasia, Cervical dysplasia, STI, Lymphoma, Seborrhoeic dermatitis, Exanthema, Thrombocytpaenia, Lymphopaenia, Hypergammaglobulinaemia