CClinicalTrials.gg
CompletedNCT01138878HINTSUpdated Apr 12, 2012

HIV Testing in Non-traditional Settings Study

An observational study in HIV, sponsored by Chelsea and Westminster NHS Foundation Trust. Completed at 4 sites in United Kingdom. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-12.

Sponsored by Chelsea and Westminster NHS Foundation Trust · Observational

Study type
Observational
Time perspective
Cross-sectional
Enrollment
6,350
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • HIV

Keywords

  • HIV
  • testing
  • non traditional settings
  • acceptability
  • feasibility
03

In context

Lead sponsor

Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 53 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Inclusion criteria

  • 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

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)
05

Study design

Time perspective
Cross-sectional
Enrollment
6,350 participants (actual)

Groups and cohorts

  • Patient pre-study group

    A set of all 16-65 yr olds (not know already to be HIV-positive) accessing the healthcare setting prior to the introduction of the HIV testing pilot programme

    Other: Questionnaire · Other: Focus Group Discussion

  • Staff pre-study group

    A set of staff working within the healthcare setting prior to the introduction of the HIV screening programme

    Other: Questionnaire · Other: Focus Group Discussion

  • Patient intra-study group

    A set of patients, aged 16-65 and known not to be HIV-positive, who access the healthcare setting during the HIV testing pilot programme

    Other: Questionnaire · Other: HIV test (serum or salivary) · Other: Semi-structured telephone interview

  • Post-study staff group

    A set of staff who worked within the healthcare setting for the duration of the HIV testing pilot programme

    Other: Questionnaire · Other: Focus Group Discussion

Interventions

  • OtherQuestionnaire

    Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting

  • OtherFocus Group Discussion

    FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting

  • OtherHIV test (serum or salivary)

    An HIV test offered to all 16-65 year olds (not known already to be HIV-positive) accessing the healthcare setting during the twelve week pilot period

  • OtherSemi-structured telephone interview

    Telephone interview administered to patients offered an HIV test during the pilot period

06

What researchers measure

Primary outcomes

  1. (1) Feasibility of delivering opt-out HIV testing in ED/ACU/OPD/Primary Care setting

    Time frame: At end of twelve week testing period at each site

Secondary outcomes

  1. (2) Estimate of prevalence of undiagnosed HIV with risk factor/demographic assessment

    Time frame: At end of twelve week testing period

07

Study locations

4 sites
  • Homerton University NHS Foundation Trust
    London, E9 6SR, United Kingdom
  • Kings College Hospital NHS Foundation Trust
    London, SE5 9RS, United Kingdom
  • Chelsea and Westminster NHS Foundation Trust
    London, SW10 9NH, United Kingdom
  • North End Medical Centre, Hammersmith and Fulham Primary Care NHS Trust
    London, W14 9NP, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01138878
Lead sponsor
Chelsea and Westminster NHS Foundation Trust
Collaborators
Department of Health, Executive Yuan, R.O.C. (Taiwan), Public Health England, Homerton University Hospital NHS Foundation Trust, King's College Hospital NHS Trust, Hammersmith and Fulham Primary Care Trust
First posted
Jun 8, 2010
Start date
Jul 2009
Primary completion
Jul 2010
Completion
Dec 2011
Last update
Apr 12, 2012

Study contacts

Ann K Sullivan, MBBS FRCP
principal investigator · Chelsea and Westminster NHS Foundation Trust
Jane Anderson, MBBS FRCP
principal investigator · Homerton University Hospital NHS Foundation Trust
Melinda Tenant-Flowers, MBBS FRCP MSc
principal investigator · Kings College Hospital NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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