HIV Indicator Diseases Survey Across Europe - UK Arm

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Chelsea and Westminster NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
HIV in Europe (Co-Sponsor)
Information provided by:
Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01196468
First received: August 10, 2010
Last updated: April 11, 2012
Last verified: October 2009
  Purpose

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.


Condition Intervention
HIV
AIDS
Indicator Diseases/Indicator Conditions
Other: HIV test (serological or salivary)
Other: Interview

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: HIV Indicator Diseases Survey Across Europe

Resource links provided by NLM:


Further study details as provided by Chelsea and Westminster NHS Foundation Trust:

Primary Outcome Measures:
  • Prevalence of HIV infection in patients presenting to specific services with specific HIV indicator diseases [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Previous HIV testing behaviour of individuals presenting with an indicator disease or condition (sub-study only) [ Designated as safety issue: No ]
    Any previous history of HIV tests taken: total number, dates, and results

  • Demographic data of individuals presenting for care with specified indicator diseases [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
  • Immune status of newly-diagnosed HIV positive individuals as determined by CD4 cell count [ Designated as safety issue: No ]
  • HIV risk factors (sub-study only) [ Designated as safety issue: No ]
  • Previous medical history and health-seeking behaviour (sub-study only) [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   None Retained

Salivary or serological HIV test


Estimated Enrollment: 2000
Study Start Date: July 2010
Estimated Study Completion Date: February 2014
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anal/cervical dyplasia
Any patient presenting for care with any degree of anal or cervical dysplasia
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
Other: 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
STI
Any patient presenting for care with any non-HIV sexually transmitted infection
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
Other: 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
Lymphoma
Any patient presenting for care with malignant lymphoma of any histological type
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
Other: 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
Seborrhoeic dermatitis/exanthema
Any patient presenting for care with seborrhoeic dermatitis/exanthema
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
Other: 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
Thromobocytopaenia/Leucopaenia, or hypergammaglobulinaemia
Any patient presenting for care with unexplained thromobocytopaenia/leucopaenia of more than four weeks duration, or with hypergammaglobulinaemia
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
Other: 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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196468

Contacts
Contact: Ann K Sullivan, MBBS FRCP +44 (0)208 746 8000 ext 56199 ann.sullivan@chelwest.nhs.uk
Contact: Michael Rayment, MBBS MA MRCP +44 (0)208 746 8000 ext 56529 michaelrayment@nhs.net

Locations
United Kingdom
Chelsea and Westminster NHS Foundation Trust Recruiting
London, United Kingdom, SW10 9NH
Principal Investigator: Ann K Sullivan, MBBS FRCP         
Sub-Investigator: Nick Wales, MBBS FRCOG         
Sub-Investigator: Helen Yarranton, MRCP MRCPath         
Sub-Investigator: Chris Bunker, MBBS FRCP         
Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Principal Investigator: David Cunningham, PhD FRCP         
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
HIV in Europe (Co-Sponsor)
Investigators
Principal Investigator: Ann K Sullivan, MBBS FRCP Chelsea and Westminster NHS Foundation Trust
Study Director: Jens Lundgren, MBBS University of Copenhagen and Righospitalet
Principal Investigator: David Cunningham, PhD FRCP Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Ann Sullivan, Chelsea and Westminster NHS Foundation Trust, London, UK
ClinicalTrials.gov Identifier: NCT01196468     History of Changes
Other Study ID Numbers: Indicator Diseases Survey
Study First Received: August 10, 2010
Last Updated: April 11, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Chelsea and Westminster NHS Foundation Trust:
HIV
Testing
Targeted
Indicator
Diseases
Anal dysplasia
Cervical dysplasia
STI
Lymphoma
Seborrhoeic dermatitis
Exanthema
Thrombocytpaenia
Lymphopaenia
Hypergammaglobulinaemia

ClinicalTrials.gov processed this record on October 28, 2014