HIV Testing in Non-traditional Settings Study (HINTS)
This study has been completed.
Sponsor:
Chelsea and Westminster NHS Foundation Trust
Collaborators:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Health Protection Agency, United Kingdom
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
ClinicalTrials.gov Identifier:
NCT01138878
First received: June 4, 2010
Last updated: April 11, 2012
Last verified: May 2010
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Purpose
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 | Intervention |
|---|---|
|
HIV |
Other: Questionnaire Other: Focus Group Discussion Other: HIV test (serum or salivary) Other: Semi-structured telephone interview |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | HIV Testing in Non-traditional Settings Study |
Resource links provided by NLM:
Further study details as provided by Chelsea and Westminster NHS Foundation Trust:
Primary Outcome Measures:
- (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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- (2) Estimate of prevalence of undiagnosed HIV with risk factor/demographic assessment [ Time Frame: At end of twelve week testing period ] [ Designated as safety issue: No ]
| Enrollment: | 6350 |
| Study Start Date: | July 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138878
Locations
| United Kingdom | |
| Chelsea and Westminster NHS Foundation Trust | |
| London, United Kingdom, SW10 9NH | |
| Kings College Hospital NHS Foundation Trust | |
| London, United Kingdom, SE5 9RS | |
| Homerton University NHS Foundation Trust | |
| London, United Kingdom, E9 6SR | |
| 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)
Health Protection Agency, United Kingdom
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
No publications provided
| Responsible Party: | Dr Ann Sullivan, Chelsea and Westminster NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01138878 History of Changes |
| Other Study ID Numbers: | 1.4 |
| Study First Received: | June 4, 2010 |
| Last Updated: | April 11, 2012 |
| Health Authority: | UK: 'National Research Ethics Committee' |
Keywords provided by Chelsea and Westminster NHS Foundation Trust:
|
HIV testing non traditional settings acceptability feasibility |
Additional relevant MeSH terms:
|
HIV Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013