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Trial of human immunodeficiency virus (HIV) screening in Primary Care

Effectiveness of human immunodeficiency virus (HIV) screening in Primary Care: a cluster randomised controlled trial (RCT) and economic analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63473710
Enrollment
23000
Registered
2010-04-22
Start date
2010-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) Infections and Infestations Unspecified human immunodeficiency virus [HIV] disease

Interventions

Intervention surgeries: The formative phase for intervention surgeries will include the following: 1. Analysis of the educational requirements for GPs nurses and health care assistants 2. Provision of
a further test and specialist follow up. The HIV specialist nurse, a member of the clinical management team at the Department of Sexual Health at Homerton Hospital, will liaise with both GP surgeries
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Sponsors

Queen Mary's University of London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Individuals aged 16 years or older registering at study practices, either sex 2. Individuals able to undertake the pre-test discussion in English or with a suitable translator

Exclusion criteria

Exclusion criteria: 1. Aged under 16 years 2. Individuals with limited English abilities, who are unable to understand the info sheet or, who are unable to engage with the pre-test discussion for HIV testing 3. Known HIV positive patients

Design outcomes

Primary

MeasureTime frame
Rates of new HIV diagnoses: numbers of rapid and standard HIV tests done in new patient health checks Outcomes are measured quarterly.

Secondary

MeasureTime frame
Immunological outcomes: 1. Numbers of patients diagnosed during early HIV infection defined as CD4 count higher than 200 cells per cubic millimetre blood Viral outcomes: 2. HIV viral load, clade and genotype of the virus at the time of diagnosis as predictors of disease progression Health service use: 3. Numbers of registering patients 4. Numbers of standard HIV tests done opportunistically 5. Numbers of New Patient Health Checks carried out Economic outcomes: 6. Cost-effectiveness of the intervention compared to standard of care Outcomes are measured quarterly.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026