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

NCT02804724 | Completed

• 1 other identifier: 2-030-15
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV; Human immunodeficiency virus; Late diagnosis

Outcome Measures

Primary Outcomes (14)

• Age at diagnosis

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

  5 years

• Gender

  Gender; compared between early and late diagnosis groups

  5 years

• 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

• Ethnicity

  Ethnic group; compared between early and late diagnosis groups

  5 years

• Migrant status

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

  5 years

• Probable mode of transmission

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

  5 years

• Probable region of exposure

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

  5 years

• Registration with General Practitioner

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

  5 years

• 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

• 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

• Previous HIV testing

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

  5 years

• 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

• 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

• 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

Secondary Outcomes (2)

• Frequency of missed opportunities for diagnosis

  5 years

• Circumstance of HIV diagnosis

  5 years

Study Arms (1)

Newly diagnosed individuals with HIV

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

Other: No intervention

Interventions

No intervention OTHER

Newly diagnosed individuals with HIV

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Individuals aged \< 16 years of age

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

NHS Grampian

Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 22455558 BACKGROUND

• 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.

  PMID: 15894552 BACKGROUND

• 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.

  PMID: 23101142 BACKGROUND

• 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.

  PMID: 18624028 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Emmanuel Okpo, MBBS FFPH

  NHS Grampian and University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: June 17, 2016
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 17, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)