HIVNCT01196468
HIV Indicator Diseases Survey Across Europe - UK Arm
An observational study of HIV and AIDS, run by Chelsea and Westminster NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV, AIDS, Indicator Diseases/Indicator Conditions
- What is being tested?
- HIV test (serological or salivary) and Interview
- How many people
- 2,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2010to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults (16 years and over), not known already to be HIV-positive, presenting for care in designated healthcare settings with one of five "indicator diseases." Sequential patients will be offered HIV tests, and if they accept, asked to provide additional information via focussed interview (sub-study).
Who may be able to join
- 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
Who cannot join
- Known HIV positive
- sub-study - declines to consent for additional information to be collected
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Chelsea and Westminster NHS Foundation Trust
London, SW10 9NH
Ann K Sullivan, MBBS FRCP
Nick Wales, MBBS FRCOG
- Recruiting
Royal Marsden NHS Foundation Trust
London, SW3 6JJ
David Cunningham, PhD FRCP
About this study
Official title: HIV Indicator Diseases Survey Across Europe
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.
Read more
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.
- Conditions
- HIV, AIDS, Indicator Diseases/Indicator Conditions
- Being tested
- HIV test (serological or salivary), Interview
- Keywords
- HIV, Testing, Targeted, Indicator, Diseases, Anal dysplasia, Cervical dysplasia, STI, Lymphoma, Seborrhoeic dermatitis, Exanthema, Thrombocytpaenia, Lymphopaenia, Hypergammaglobulinaemia
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Disease, Uterine Cervical Dysplasia, Sexually Transmitted Diseases, Lymphoma, Dermatitis, Seborrheic, Exanthema, Hypergammaglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV test (serological or salivary)Other
An HIV test will be offered to all patients accessing the healthcare setting for care of the "indicator" condition
InterviewOther
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
| Study group | Role | What they receive |
|---|---|---|
| Anal/cervical dyplasia | Any patient presenting for care with any degree of anal or cervical dysplasia Receives: Other: HIV test (serological or salivary); Other: Interview | |
| STI | Any patient presenting for care with any non-HIV sexually transmitted infection Receives: Other: HIV test (serological or salivary); Other: Interview | |
| Lymphoma | Any patient presenting for care with malignant lymphoma of any histological type Receives: Other: HIV test (serological or salivary); Other: Interview | |
| Seborrhoeic dermatitis/exanthema | Any patient presenting for care with seborrhoeic dermatitis/exanthema Receives: Other: HIV test (serological or salivary); Other: Interview | |
| Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia | Any patient presenting for care with unexplained thromobocytopaenia/leucopaenia of more than four weeks duration, or with hypergammaglobulinaemia Receives: Other: HIV test (serological or salivary); Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- HIV in Europe (Co-Sponsor)
- Investigators
- Ann K Sullivan, MBBS FRCP, Principal investigator, Chelsea and Westminster NHS Foundation TrustJens Lundgren, MBBS, Study director, University of Copenhagen and RighospitaletDavid Cunningham, PhD FRCP, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196468
- Sponsor's protocol ID
- Indicator Diseases Survey
- Status last verified
- Oct 2009
- First submitted
- 10 Aug 2010
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Indicator Diseases Survey Across Europe
- ClinicalTrials.gov ID
- NCT01196468
- Acronym / sponsor ID
- Indicator Diseases Survey
- Conditions
- HIV, AIDS, Indicator Diseases/Indicator Conditions
- Keywords
- HIV, Testing, Targeted, Indicator, Diseases, Anal dysplasia, Cervical dysplasia, STI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- HIV in Europe (Co-Sponsor)
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2014 (estimated)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anal/cervical dyplasia | – | Other: HIV test (serological or salivary), Other: InterviewAny patient presenting for care with any degree of anal or cervical dysplasia |
| STI | – | Other: HIV test (serological or salivary), Other: InterviewAny patient presenting for care with any non-HIV sexually transmitted infection |
| Lymphoma | – | Other: HIV test (serological or salivary), Other: InterviewAny patient presenting for care with malignant lymphoma of any histological type |
| Seborrhoeic dermatitis/exanthema | – | Other: HIV test (serological or salivary), Other: InterviewAny patient presenting for care with seborrhoeic dermatitis/exanthema |
| Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia | – | Other: HIV test (serological or salivary), Other: InterviewAny patient presenting for care with unexplained thromobocytopaenia/leucopaenia of more than four weeks duration, or with hypergammaglobulinaemia |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults (16 years and over), not known already to be HIV-positive, presenting for care in designated healthcare settings with one of five "indicator diseases." Sequential patients will be offered HIV tests, and if they accept, asked to provide additional information via focussed interview (sub-study).
Key inclusion criteria (8 listed)
- Aged 16 years and over
- Presenting for care with one of the indicator diseases or conditions:
- sub-study - consents to providing additional information
Key exclusion criteria (2 listed)
- Known HIV positive
- sub-study - declines to consent for additional information to be collected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV test (serological or salivary)An HIV test will be offered to all patients accessing the healthcare setting for care of the "indicator" condition | Other | Anal/cervical dyplasia, Lymphoma, STI, Seborrhoeic dermatitis/exanthema, Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia |
| InterviewDemographic 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 | Other | Anal/cervical dyplasia, Lymphoma, STI, Seborrhoeic dermatitis/exanthema, Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia |
Primary outcome
Prevalence of HIV infection in patients presenting to specific services with specific HIV indicator diseases
6 secondary outcomes
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)
Previous medical history and health-seeking behaviour (sub-study only)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann K Sullivan, MBBS FRCP principal investigator
Chelsea and Westminster NHS Foundation Trust
Jens Lundgren, MBBS study director
University of Copenhagen and Righospitalet
David Cunningham, PhD FRCP principal investigator
Royal Marsden NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and AIDS, run by Chelsea and Westminster NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann K Sullivan, MBBS FRCP (+44 (0)208 746 8000 ext. 56199, ann.sullivan@chelwest.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HIV infection in patients presenting to specific services with specific HIV indicator diseases. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2012.