HIV Indicator Diseases Survey Across Europe - UK Arm

HIV Clinical Trial

Official title:

HIV Indicator Diseases Survey Across Europe

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01196468
• Other study ID #: Indicator Diseases Survey
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2010
• Last updated: April 11, 2012
• Start date: July 2010
• Est. completion date: February 2014

Study information

• Verified date: October 2009
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: Ann K Sullivan, MBBS FRCP
• Phone: +44 (0)208 746 8000
• Email: ann.sullivan[@]chelwest.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 2014
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• AIDS
• HIV
• Indicator Diseases/Indicator Conditions

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster NHS Foundation Trust	London
United Kingdom	Royal Marsden NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust	HIV in Europe (Co-Sponsor)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of HIV infection in patients presenting to specific services with specific HIV indicator diseases			No
Secondary	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		No
Secondary	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)		No
Secondary	Time to transfer to care for those individuals testing HIV positive			No
Secondary	Immune status of newly-diagnosed HIV positive individuals as determined by CD4 cell count			No
Secondary	HIV risk factors (sub-study only)			No
Secondary	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.		No

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