HIV Testing in Non-traditional Settings Study (HINTS)

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 Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: Questionnaire; Other: Focus Group Discussion; Other: HIV test (serum or salivary); Other: Semi-structured telephone interview

• Study Type: Observational
• Enrollment (Actual): 6350

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital NHS Foundation Trust
  • London, United Kingdom, E9 6SR
    • Homerton University NHS Foundation Trust
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster NHS Foundation Trust
  • London, United Kingdom, W14 9NP
    • North End Medical Centre, Hammersmith and Fulham Primary Care NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 4, 2010
• First Submitted That Met QC Criteria: June 7, 2010
• First Posted (Estimate): June 8, 2010

Study Record Updates

• Last Update Posted (Estimate): April 12, 2012
• Last Update Submitted That Met QC Criteria: April 11, 2012
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: HIV; feasibility; testing; acceptability; non traditional settings
• Other Study ID Numbers: 1.4