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HIV Testing in Non-traditional Settings Study (HINTS)

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ClinicalTrials.gov Identifier: NCT01138878
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : April 12, 2012
Sponsor:
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
Information provided by:
Chelsea and Westminster NHS Foundation Trust

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
HIV Other: Questionnaire Other: Focus Group Discussion Other: HIV test (serum or salivary) Other: Semi-structured telephone interview

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 6350 participants
Time Perspective: Cross-Sectional
Official Title: HIV Testing in Non-traditional Settings Study
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting
Other: Focus Group Discussion
FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting
Staff pre-study group
A set of staff working within the healthcare setting prior to the introduction of the HIV screening programme
 Other: Questionnaire
Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting
Other: Focus Group Discussion
FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting
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
Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting
Other: HIV 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
Other: Semi-structured telephone interview
Telephone interview administered to patients offered an HIV test during the pilot period
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
Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting
Other: Focus Group Discussion
FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  1. (2) Estimate of prevalence of undiagnosed HIV with risk factor/demographic assessment [ Time Frame: At end of twelve week testing period ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   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

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)
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138878


Locations
United Kingdom
Homerton University NHS Foundation Trust
London, United Kingdom, E9 6SR
Kings College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Chelsea and Westminster NHS Foundation Trust
London, United Kingdom, SW10 9NH
North End Medical Centre, Hammersmith and Fulham Primary Care NHS Trust
London, United Kingdom, W14 9NP
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
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
Investigators
Principal Investigator: Ann K Sullivan, MBBS FRCP Chelsea and Westminster NHS Foundation Trust
Principal Investigator: Jane Anderson, MBBS FRCP Homerton University Hospital NHS Foundation Trust
Principal Investigator: Melinda Tenant-Flowers, MBBS FRCP MSc Kings College Hospital NHS Foundation Trust
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr Ann Sullivan, Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01138878     History of Changes
Other Study ID Numbers: 1.4
First Posted: June 8, 2010    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: May 2010

Keywords provided by Chelsea and Westminster NHS Foundation Trust:
HIV
testing
non traditional settings
acceptability
feasibility