HIV Testing in Non-traditional Settings Study (HINTS)

This study has been completed.

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

ClinicalTrials.gov Identifier:

NCT01138878

First received: June 4, 2010

Last updated: April 11, 2012

Last verified: May 2010

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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


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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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

Keywords provided by Chelsea and Westminster NHS Foundation Trust:


HIV testing non traditional settings acceptability feasibility

ClinicalTrials.gov processed this record on June 26, 2017

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