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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804724
• Other study ID #: 2-030-15
• Status: Completed
• Phase: N/A
• First received: June 29, 2015
• Last updated: June 14, 2016
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: June 2016
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
United Kingdom	NHS Grampian	Aberdeen	Aberdeen City

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View Citation

Lucas SB, Curtis H, Johnson MA. National review of deaths among HIV-infected adults. Clin Med (Lond). 2008 Jun;8(3):250-2. — View 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. Epub 2005 May 13. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age at diagnosis	Age in years at diagnosis; compared between early and late diagnosis groups.	5 years	No
Primary	Gender	Gender; compared between early and late diagnosis groups	5 years	No
Primary	Scottish Index of Multiple Deprivation (SIMD) Quintile	SIMD quintile (1 representing most deprived to 5 representing least deprived); compared between early and late diagnosis groups	5 years	No
Primary	Ethnicity	Ethnic group; compared between early and late diagnosis groups	5 years	No
Primary	Migrant status	Migrant status in relation to the United Kingdom; compared between early and late diagnosis groups	5 years	No
Primary	Probable mode of transmission	Probable mode of HIV transmission; compared between early and late diagnosis groups	5 years	No
Primary	Probable region of exposure	Probable region of exposure to HIV; compared between early and late diagnosis groups	5 years	No
Primary	Registration with General Practitioner	Current registration status with General Practitioner; compared between early and late diagnosis groups	5 years	No
Primary	Contact with healthcare professional	Contact with healthcare professional(s) in the year preceding HIV diagnosis (contact versus no contact); compared between early and late diagnosis groups	5 years	No
Primary	Frequency of healthcare contacts	Frequency of contact with healthcare professional(s) in the year preceding HIV diagnosis; compared between early and late diagnosis groups	5 years	No
Primary	Previous HIV testing	Previous HIV testing (no testing versus testing); compared between early and late diagnosis groups	5 years	No
Primary	Clinical indicator disease	Presence or absence of a BHIVA clinical indicator disease in the five years preceding diagnosis; compared between early and late diagnosis groups	5 years	No
Primary	Number of clinical indicator disease(s)	Number of BHIVA clinical indicator disease(s) present in the five years preceding diagnosis; compared between early and late diagnosis groups	5 years	No
Primary	Co-existing hepatitis B/C infection	Presence or absence of a co-existing hepatitis B/C infection; compared between early and late diagnosis groups	5 years	No
Secondary	Frequency of missed opportunities for diagnosis	Number of missed opportunities for diagnosis as defined by the BHIVA testing guidelines; compared between early and late diagnosis groups	5 years	No
Secondary	Circumstance of HIV diagnosis	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	No

External Links

•   Public Health England. HIV in the United Kingdom: 2014 Report