- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Aberdeen City
-
Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
- NHS Grampian
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Newly diagnosed individuals with HIV
Individuals newly diagnosed with HIV in Grampian between January 2009 and December 2014
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age at diagnosis
Time Frame: 5 years
|
Age in years at diagnosis; compared between early and late diagnosis groups.
|
5 years
|
Gender
Time Frame: 5 years
|
Gender; compared between early and late diagnosis groups
|
5 years
|
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
|
5 years
|
Ethnicity
Time Frame: 5 years
|
Ethnic group; compared between early and late diagnosis groups
|
5 years
|
Migrant status
Time Frame: 5 years
|
Migrant status in relation to the United Kingdom; compared between early and late diagnosis groups
|
5 years
|
Probable mode of transmission
Time Frame: 5 years
|
Probable mode of HIV transmission; compared between early and late diagnosis groups
|
5 years
|
Probable region of exposure
Time Frame: 5 years
|
Probable region of exposure to HIV; compared between early and late diagnosis groups
|
5 years
|
Registration with General Practitioner
Time Frame: 5 years
|
Current registration status with General Practitioner; compared between early and late diagnosis groups
|
5 years
|
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
|
5 years
|
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
|
5 years
|
Previous HIV testing
Time Frame: 5 years
|
Previous HIV testing (no testing versus testing); compared between early and late diagnosis groups
|
5 years
|
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
|
5 years
|
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
|
5 years
|
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
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 years
|
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
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emmanuel Okpo, MBBS FFPH, NHS Grampian and University of Aberdeen
Publications and helpful links
General Publications
- Wohlgemut J, Lawes T, Laing RB. Trends in missed presentations and late HIV diagnosis in a UK teaching hospital: a retrospective comparative cohort study. BMC Infect Dis. 2012 Mar 28;12:72. doi: 10.1186/1471-2334-12-72.
- Sullivan AK, Curtis H, Sabin CA, Johnson MA. Newly diagnosed HIV infections: review in UK and Ireland. BMJ. 2005 Jun 4;330(7503):1301-2. doi: 10.1136/bmj.38398.590602.E0. Epub 2005 May 13. No abstract available.
- Ellis S, Curtis H, Ong EL; British HIV Association (BHIVA); BHIVA Clinical Audit and Standards sub-committee. HIV diagnoses and missed opportunities. Results of the British HIV Association (BHIVA) National Audit 2010. Clin Med (Lond). 2012 Oct;12(5):430-4. doi: 10.7861/clinmedicine.12-5-430.
- Lucas SB, Curtis H, Johnson MA. National review of deaths among HIV-infected adults. Clin Med (Lond). 2008 Jun;8(3):250-2. doi: 10.7861/clinmedicine.8-3-250.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- 2-030-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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