Human Immunodeficiency VirusNCT02804724
Factors Associated With Late HIV Diagnosis in Grampian: an Epidemiological Study
An observational study of Human Immunodeficiency Virus, run by University of Aberdeen at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- How many people
- 124 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals newly diagnosed with HIV in Grampian between January 2009 and December 2014
Who may be able to join
- Individuals diagnosed with HIV between January 2009 and December 2014
- Individuals diagnosed in NHS Grampian
Who cannot join
- Individuals aged < 16 years of age
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- No intervention
- Keywords
- HIV, Human immunodeficiency virus, Late diagnosis
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed individuals with HIV | Individuals newly diagnosed with HIV in Grampian between January 2009 and December 2014 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at diagnosis
Age in years at diagnosis; compared between early and late diagnosis groups.
Measured: 5 years
Gender
Gender; compared between early and late diagnosis groups
Measured: 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
Measured: 5 years
Ethnicity
Ethnic group; compared between early and late diagnosis groups
Measured: 5 years
Migrant status
Migrant status in relation to the United Kingdom; compared between early and late diagnosis groups
Measured: 5 years
Probable mode of transmission
Probable mode of HIV transmission; compared between early and late diagnosis groups
Measured: 5 years
Probable region of exposure
Probable region of exposure to HIV; compared between early and late diagnosis groups
Measured: 5 years
Registration with General Practitioner
Current registration status with General Practitioner; compared between early and late diagnosis groups
Measured: 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
Measured: 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
Measured: 5 years
Previous HIV testing
Previous HIV testing (no testing versus testing); compared between early and late diagnosis groups
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years
Secondary outcomes (2)
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
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Emmanuel Okpo, MBBS FFPH, Principal investigator, NHS Grampian and University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804724
- Sponsor's protocol ID
- 2-030-15
- Status last verified
- Jun 2016
- First submitted
- 29 Jun 2015
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 22455558Sullivan 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.
PubMed 15894552Ellis 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.
PubMed 23101142Lucas 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.
PubMed 18624028
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Late HIV Diagnosis in Grampian: an Epidemiological Study
- ClinicalTrials.gov ID
- NCT02804724
- Acronym / sponsor ID
- 2-030-15
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, Human immunodeficiency virus, Late diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed individuals with HIV | – | Other: No interventionIndividuals newly diagnosed with HIV in Grampian between January 2009 and December 2014 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals newly diagnosed with HIV in Grampian between January 2009 and December 2014
Key inclusion criteria (2 listed)
- Individuals diagnosed with HIV between January 2009 and December 2014
- Individuals diagnosed in NHS Grampian
Key exclusion criteria (1 listed)
- Individuals aged < 16 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Newly diagnosed individuals with HIV |
Primary outcome
Age at diagnosis
Time frame: 5 years
Age in years at diagnosis; compared between early and late diagnosis groups.
Gender
Time frame: 5 years
Gender; compared between early and late diagnosis groups
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
Ethnicity
Time frame: 5 years
Ethnic group; compared between early and late diagnosis groups
Migrant status
Time frame: 5 years
Migrant status in relation to the United Kingdom; compared between early and late diagnosis groups
Probable mode of transmission
Time frame: 5 years
Probable mode of HIV transmission; compared between early and late diagnosis groups
Probable region of exposure
Time frame: 5 years
Probable region of exposure to HIV; compared between early and late diagnosis groups
Registration with General Practitioner
Time frame: 5 years
Current registration status with General Practitioner; compared between early and late diagnosis groups
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
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
Previous HIV testing
Time frame: 5 years
Previous HIV testing (no testing versus testing); compared between early and late diagnosis groups
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
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
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
2 secondary outcomes
Frequency of missed opportunities for diagnosis
Time frame: 5 years
Circumstance of HIV diagnosis
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Background: PubMed 22455558Wohlgemut 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.
- Background: PubMed 15894552Sullivan 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.
- Background: PubMed 23101142Ellis 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.
- Background: PubMed 18624028Lucas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Okpo, MBBS FFPH principal investigator
NHS Grampian and University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age at diagnosis (time frame: 5 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02804724, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.