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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804724
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Collaborator:
NHS Grampian
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:

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.


Condition or disease Intervention/treatment
Human Immunodeficiency Virus Other: No intervention

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Study Type : Observational
Actual Enrollment : 124 participants
Time Perspective: Retrospective
Official Title: Factors Associated With Late HIV Diagnosis in Grampian: an Epidemiological Study
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Newly diagnosed individuals with HIV
Individuals newly diagnosed with HIV in Grampian between January 2009 and December 2014
Other: No intervention



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals newly diagnosed with HIV in Grampian between January 2009 and December 2014
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804724


Locations
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United Kingdom
NHS Grampian
Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Investigators
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Principal Investigator: Emmanuel Okpo, MBBS FFPH NHS Grampian and University of Aberdeen
Additional Information:
Publications:
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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT02804724    
Other Study ID Numbers: 2-030-15
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Aberdeen:
HIV
Human immunodeficiency virus
Late diagnosis
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases