Clinical trial NCT02804724: Factors Associated With Late HIV Diagnosis in Grampian: an Epidemiological Study
Official title: Factors Associated With Late HIV Diagnosis in Grampian: an Epidemiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: HIV
Human immunodeficiency virus
Late diagnosis
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2016-06-17
Enrollment: 124
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals newly diagnosed with HIV in Grampian between January 2009 and December 2014

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.


Eligibility 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

Primary outcomes:
measure: Age at diagnosis
timeFrame: 5 years
measure: Gender
timeFrame: 5 years
measure: Scottish Index of Multiple Deprivation (SIMD) Quintile
timeFrame: 5 years
measure: Ethnicity
timeFrame: 5 years
measure: Migrant status
timeFrame: 5 years
measure: Probable mode of transmission
timeFrame: 5 years
measure: Probable region of exposure
timeFrame: 5 years
measure: Registration with General Practitioner
timeFrame: 5 years
measure: Contact with healthcare professional
timeFrame: 5 years
measure: Frequency of healthcare contacts
timeFrame: 5 years
measure: Previous HIV testing
timeFrame: 5 years
measure: Clinical indicator disease
timeFrame: 5 years
measure: Number of clinical indicator disease(s)
timeFrame: 5 years
measure: Co-existing hepatitis B/C infection
timeFrame: 5 years
Secondary outcomes:
measure: Frequency of missed opportunities for diagnosis
timeFrame: 5 years
measure: Circumstance of HIV diagnosis
timeFrame: 5 years
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
state: Aberdeen City
Study officials:
affiliation: NHS Grampian and University of Aberdeen
name: Emmanuel Okpo, MBBS FFPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.