Clinical trial NCT01138878: HIV Testing in Non-traditional Settings Study
Official title: HIV Testing in Non-traditional Settings Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
testing
non traditional settings
acceptability
feasibility
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
name: Public Health England
name: Homerton University Hospital NHS Foundation Trust
name: King's College Hospital NHS Trust
name: Hammersmith and Fulham Primary Care Trust
First posted: 2010-06-08
Enrollment: 6350
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For patient pre-study and intra-study: All patients aged 16-65 (not know already to be HIV positive) attending the healthcare setting (Primary Care centre, Emergency Department, Acute Care Unit, Medical Outpatient Clinic) before or during the twelve week HIV testing pilot programme

For Staff pre-study and post-study: All members of staff (HCP, Allied Health Professionals and Admin/Clerical) working within the healthcare settings examined before and during the implementation of the HIV testing programme

Brief summary: Surveillance data suggests that approximately one third of the 82 000 HIV infected adults in the UK remain undiagnosed - that is, they are living with the infection but do not know this. The majority of HIV testing in the UK to date has taken place in sexual health clinics and in antenatal care. Published National guidelines advocate routine HIV testing of 16-65 year olds in more general healthcare settings in parts of the country with relatively high rates of HIV (more than 2 per thousand individuals diagnosed locally). The HINTS Study investigates the utility, feasibility and acceptability, to patients and staff, of offering routine HIV testing in four general medical settings, all set in areas of high HIV prevalence. The settings comprise: Primary Care, Outpatients, an Acute Care Unit and an Emergency Department.


Eligibility criteria: Inclusion Criteria (patient study only):

* aged 16 - 65 and accessing relevant healthcare setting for care
* able to consent to HIV test
* able to provide adequate contact details
* to complete written questionnaire: adequate written English
* to participate in focus group discussion (pre-study group)/participate in semi-structured telephone interview (intra-study group): ability to provide fully informed consent

Exclusion Criteria:

* known HIV positive
* unable to provide adequate contact details
* unable to provide consent (to HIV test and/or participation in questionnaire/focus group/semi-structured interview studies)

Primary outcomes:
measure: (1) Feasibility of delivering opt-out HIV testing in ED/ACU/OPD/Primary Care setting
timeFrame: At end of twelve week testing period at each site
Secondary outcomes:
measure: (2) Estimate of prevalence of undiagnosed HIV with risk factor/demographic assessment
timeFrame: At end of twelve week testing period
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Homerton University NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster NHS Foundation Trust
city: London
country: United Kingdom
facility: North End Medical Centre, Hammersmith and Fulham Primary Care NHS Trust
Study officials:
affiliation: Chelsea and Westminster NHS Foundation Trust
name: Ann K Sullivan, MBBS FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Homerton University Hospital NHS Foundation Trust
name: Jane Anderson, MBBS FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Kings College Hospital NHS Foundation Trust
name: Melinda Tenant-Flowers, MBBS FRCP MSc
role: PRINCIPAL_INVESTIGATOR
References: