HIV Testing in Non-traditional Settings Study

NCT01138878 | Completed

• 1 other identifier: 1.4
• Study Type: observational
• Target: 6,350
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

HIV

Keywords

HIV; testing; non traditional settings; acceptability; feasibility

Outcome Measures

Primary Outcomes (1)

• (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 Outcomes (1)

• (2) Estimate of prevalence of undiagnosed HIV with risk factor/demographic assessment

  At end of twelve week testing period

Study Arms (4)

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; 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

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

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

Other: Questionnaire; Other: Focus Group Discussion

Interventions

Questionnaire OTHER

Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting

Patient intra-study group; Patient pre-study group; Post-study staff group; Staff pre-study group

Focus Group Discussion OTHER

FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting

Patient pre-study group; Post-study staff group; Staff pre-study group

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

Patient intra-study group

Semi-structured telephone interview OTHER

Telephone interview administered to patients offered an HIV test during the pilot period

Patient intra-study group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (4)

Homerton University NHS Foundation Trust

London, E9 6SR, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Chelsea and Westminster NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

North End Medical Centre, Hammersmith and Fulham Primary Care NHS Trust

London, W14 9NP, United Kingdom

Location

MeSH Terms

Interventions

Surveys and Questionnaires; HIV Testing

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 8, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2011
• Last Updated: April 12, 2012

Record last verified: 2010-05

Locations

GB (4)