HIV Testing in Non-traditional Settings Study

Study Overview
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Brief Summary
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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.

Official Title
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HIV Testing in Non-traditional Settings Study

Conditions
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HIV

Intervention / Treatment
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* Other: Questionnaire
* Other: Focus Group Discussion
* Other: HIV test (serum or salivary)
* Other: Semi-structured telephone interview


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient pre-study group<br>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<br>* Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting<br>Other: Focus Group Discussion<br>* FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting<br>|
| Staff pre-study group<br>A set of staff working within the healthcare setting prior to the introduction of the HIV screening programme | Other: Questionnaire<br>* Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting<br>Other: Focus Group Discussion<br>* FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting<br>|
| Patient intra-study group<br>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<br>* Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting<br>Other: HIV test (serum or salivary)<br>* 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<br>Other: Semi-structured telephone interview<br>* Telephone interview administered to patients offered an HIV test during the pilot period<br>|
| Post-study staff group<br>A set of staff who worked within the healthcare setting for the duration of the HIV testing pilot programme | Other: Questionnaire<br>* Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting<br>Other: Focus Group Discussion<br>* FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, testing, non traditional settings, acceptability, feasibility