Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

2,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach

1 country

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.6 years study duration

Study Start

First participant enrolled

July 1, 2010

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2010

Completed

29 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed

2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed

Last Updated

April 12, 2012

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

August 10, 2010

Last Update Submit

April 11, 2012

Conditions

HIV AIDS Indicator Diseases/Indicator Conditions

Keywords

HIVTestingTargetedIndicatorDiseasesAnal dysplasiaCervical dysplasiaSTILymphomaSeborrhoeic dermatitisExanthemaThrombocytpaeniaLymphopaeniaHypergammaglobulinaemia

Outcome Measures

Primary Outcomes (1)

Prevalence of HIV infection in patients presenting to specific services with specific HIV indicator diseases

Secondary Outcomes (6)

Previous HIV testing behaviour of individuals presenting with an indicator disease or condition (sub-study only)
Demographic data of individuals presenting for care with specified indicator diseases
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)
+1 more secondary outcomes