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NCT Number: NCT02804724

Factors Associated With Late HIV Diagnosis in Grampian: an Epidemiological Study

Human immunodeficiency virus (HIV) is a major global health concern which has resulted in an estimated 39 million deaths world-wide. Although it is now a treatable medical condition there is still avoidable morbidity and mortality associated with HIV infection in the UK. Late diagnosis (CD4 count of <350 cells/mm3 or AIDS-defining illness irrespective of CD4 count) is associated with increased morbidity and mortality, increased risk of transmission, impaired response to antiretroviral therapy and increased healthcare costs. In Grampian, 49% of patients were diagnosed late between 1984 and 2011. Therefore, the aim of the study is to determine the factors associated with late HIV diagnosis in Grampian between 2009 and 2014 to ascertain whether diagnoses could have been made earlier.

The study constitutes a secondary data analysis. Individuals newly diagnosed with HIV between January 2009 and December 2014 were identified from a Health Protection Scotland (HPS) database. The majority of outcome data were extracted from the existing HPS database. Missing data were collected via a retrospective review of patient case-notes, laboratory reports and an electronic patient management system. Patients were classified as early or late diagnosis and comparisons were made between the groups using statistical tests. The study sought to provide a basis for recommendations for improvement of information and services to facilitate earlier HIV diagnosis in Grampian.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Grampian

Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals diagnosed with HIV between January 2009 and December 2014
  • Individuals diagnosed in NHS Grampian

Exclusion criteria

  • Individuals aged < 16 years of age

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Age at diagnosis

    Time frame: 5 years

    Age in years at diagnosis; compared between early and late diagnosis groups.

  2. Gender

    Time frame: 5 years

    Gender; compared between early and late diagnosis groups

  3. Scottish Index of Multiple Deprivation (SIMD) Quintile

    Time frame: 5 years

    SIMD quintile (1 representing most deprived to 5 representing least deprived); compared between early and late diagnosis groups

  4. Ethnicity

    Time frame: 5 years

    Ethnic group; compared between early and late diagnosis groups

  5. Migrant status

    Time frame: 5 years

    Migrant status in relation to the United Kingdom; compared between early and late diagnosis groups

  6. Probable mode of transmission

    Time frame: 5 years

    Probable mode of HIV transmission; compared between early and late diagnosis groups

  7. Probable region of exposure

    Time frame: 5 years

    Probable region of exposure to HIV; compared between early and late diagnosis groups

  8. Registration with General Practitioner

    Time frame: 5 years

    Current registration status with General Practitioner; compared between early and late diagnosis groups

  9. Contact with healthcare professional

    Time frame: 5 years

    Contact with healthcare professional(s) in the year preceding HIV diagnosis (contact versus no contact); compared between early and late diagnosis groups

  10. Frequency of healthcare contacts

    Time frame: 5 years

    Frequency of contact with healthcare professional(s) in the year preceding HIV diagnosis; compared between early and late diagnosis groups

  11. Previous HIV testing

    Time frame: 5 years

    Previous HIV testing (no testing versus testing); compared between early and late diagnosis groups

  12. Clinical indicator disease

    Time frame: 5 years

    Presence or absence of a BHIVA clinical indicator disease in the five years preceding diagnosis; compared between early and late diagnosis groups

  13. Number of clinical indicator disease(s)

    Time frame: 5 years

    Number of BHIVA clinical indicator disease(s) present in the five years preceding diagnosis; compared between early and late diagnosis groups

  14. Co-existing hepatitis B/C infection

    Time frame: 5 years

    Presence or absence of a co-existing hepatitis B/C infection; compared between early and late diagnosis groups

Secondary outcomes

  1. Frequency of missed opportunities for diagnosis

    Time frame: 5 years

    Number of missed opportunities for diagnosis as defined by the BHIVA testing guidelines; compared between early and late diagnosis groups

  2. Circumstance of HIV diagnosis

    Time frame: 5 years

    Circumstance of HIV diagnosis; no BHIVA clinical indicator disease present versus testing offered following detection of a BHIVA clinical indicator disease versus no testing offered following the detection of a BHIVA clinical indicator disease. Compared between early and late diagnosis groups

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • NHS Grampian

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2016
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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