HIVHINTSNCT01138878
HIV Testing in Non-traditional Settings Study
An observational study of HIV, run by Chelsea and Westminster NHS Foundation Trust at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Questionnaire, Focus Group Discussion and HIV test (serum or salivary)
- How many people
- 6,350 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jul 2009to Dec 2011
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Homerton University NHS Foundation Trust
London, E9 6SR
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
Chelsea and Westminster NHS Foundation Trust
London, SW10 9NH
North End Medical Centre, Hammersmith and Fulham Primary Care NHS Trust
London, W14 9NP
About this study
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.
- Conditions
- HIV
- Being tested
- Questionnaire, Focus Group Discussion, HIV test (serum or salivary), Semi-structured telephone interview
- Keywords
- HIV, testing, non traditional settings, acceptability, feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting
Focus Group DiscussionOther
FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting
HIV test (serum or salivary)Other
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
Semi-structured telephone interviewOther
Telephone interview administered to patients offered an HIV test during the pilot period
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Questionnaire; Other: Focus Group Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
(1) Feasibility of delivering opt-out HIV testing in ED/ACU/OPD/Primary Care setting
Measured: 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
Measured: At end of twelve week testing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Cross-sectional
- Enrolment
- 6,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Ann K Sullivan, MBBS FRCP, Principal investigator, Chelsea and Westminster NHS Foundation TrustJane Anderson, MBBS FRCP, Principal investigator, Homerton University Hospital NHS Foundation TrustMelinda Tenant-Flowers, MBBS FRCP MSc, Principal investigator, Kings College Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138878
- Sponsor's protocol ID
- 1.4
- Acronym
- HINTS
- Status last verified
- May 2010
- First submitted
- 4 Jun 2010
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Testing in Non-traditional Settings Study
- ClinicalTrials.gov ID
- NCT01138878
- Acronym / sponsor ID
- HINTS / 1.4
- Conditions
- HIV
- Keywords
- HIV, testing, non traditional settings, acceptability, feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,350 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- 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
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Jun 2010 (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.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient pre-study group | – | Other: Questionnaire, Other: Focus Group DiscussionA 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 |
| Staff pre-study group | – | Other: Questionnaire, Other: Focus Group DiscussionA set of staff working within the healthcare setting prior to the introduction of the HIV screening programme |
| Patient intra-study group | – | Other: Questionnaire, Other: HIV test (serum or salivary), Other: Semi-structured telephone interviewA set of patients, aged 16-65 and known not to be HIV-positive, who access the healthcare setting during the HIV testing pilot programme |
| Post-study staff group | – | Other: Questionnaire, Other: Focus Group DiscussionA set of staff who worked within the healthcare setting for the duration of the HIV testing pilot programme |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| QuestionnaireAdministration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting | Other | Patient intra-study group, Patient pre-study group, Post-study staff group, Staff pre-study group |
| Focus Group DiscussionFGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting | Other | Patient pre-study group, Post-study staff group, Staff pre-study group |
| 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 | Patient intra-study group |
| Semi-structured telephone interviewTelephone interview administered to patients offered an HIV test during the pilot period | Other | Patient intra-study group |
Primary outcome
(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
1 secondary outcome
(2) Estimate of prevalence of undiagnosed HIV with risk factor/demographic assessment
Time frame: At end of twelve week testing period
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 12 Apr 2012.
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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.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Chelsea and Westminster NHS Foundation Trust at 4 sites 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 5 inclusion and 3 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 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
(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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2012.