HIV Testing in Non-traditional Settings Study

HIV Clinical Trial

— HINTS  

Official title:

HIV Testing in Non-traditional Settings Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138878
• Other study ID #: 1.4
• Status: Completed
• Phase: N/A
• First received: June 4, 2010
• Last updated: April 11, 2012
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2010
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: 'National Research Ethics Committee'
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6350
• Est. completion date: December 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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)

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Questionnaire
Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting
• Focus Group Discussion
FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting
• 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
• Semi-structured telephone interview
Telephone interview administered to patients offered an HIV test during the pilot period

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster NHS Foundation Trust	London
United Kingdom	Homerton University NHS Foundation Trust	London
United Kingdom	Kings College Hospital NHS Foundation Trust	London
United Kingdom	North End Medical Centre, Hammersmith and Fulham Primary Care NHS Trust	London

Sponsors (6)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust	Department of Health, Executive Yuan, R.O.C. (Taiwan), Hammersmith and Fulham Primary Care Trust, Homerton University Hospital NHS Foundation Trust, King's College Hospital NHS Trust, Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(1) Feasibility of delivering opt-out HIV testing in ED/ACU/OPD/Primary Care setting		At end of twelve week testing period at each site	No
Secondary	(2) Estimate of prevalence of undiagnosed HIV with risk factor/demographic assessment		At end of twelve week testing period	No