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

June 14, 2016 updated by: University of Aberdeen

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

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
        • NHS Grampian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Emmanuel Okpo, MBBS FFPH, NHS Grampian and University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Estimate)

June 17, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

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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