HIV Indicator Diseases Survey Across Europe - UK Arm
- Conditions
- HIVAIDSIndicator Diseases/Indicator Conditions
- Interventions
- Other: HIV test (serological or salivary)Other: Interview
- Registration Number
- NCT01196468
- Lead Sponsor
- Chelsea and Westminster NHS Foundation Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Anal/cervical dyplasia HIV test (serological or salivary) Any patient presenting for care with any degree of anal or cervical dysplasia Anal/cervical dyplasia Interview Any patient presenting for care with any degree of anal or cervical dysplasia Lymphoma HIV test (serological or salivary) Any patient presenting for care with malignant lymphoma of any histological type Seborrhoeic dermatitis/exanthema Interview Any patient presenting for care with seborrhoeic dermatitis/exanthema Lymphoma Interview Any patient presenting for care with malignant lymphoma of any histological type Seborrhoeic dermatitis/exanthema HIV test (serological or salivary) Any patient presenting for care with seborrhoeic dermatitis/exanthema STI HIV test (serological or salivary) Any patient presenting for care with any non-HIV sexually transmitted infection STI Interview Any patient presenting for care with any non-HIV sexually transmitted infection Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia HIV test (serological or salivary) Any patient presenting for care with unexplained thromobocytopaenia/leucopaenia of more than four weeks duration, or with hypergammaglobulinaemia Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia Interview Any patient presenting for care with unexplained thromobocytopaenia/leucopaenia of more than four weeks duration, or with hypergammaglobulinaemia
- Primary Outcome Measures
Name Time Method Prevalence of HIV infection in patients presenting to specific services with specific HIV indicator diseases
- Secondary Outcome Measures
Name Time Method HIV risk factors (sub-study only) 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 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.
Trial Locations
- Locations (2)
Chelsea and Westminster NHS Foundation Trust
🇬🇧London, United Kingdom
Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom