Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Werner Leber


Contact details

Centre for Health Sciences
Barts and The London School of Medicine and Dentistry
Abernethy Building
2 Newark Street
E1 2AT
United Kingdom
+44 (0)20 7882 7084

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

The primary objective is to demonstrate that rapid human immunodeficiency virus (HIV) testing integrated into the GP registration health check, when combined with an educational package for health care professionals, increases the rate of HIV testing and diagnoses over and above usual care.

The secondary objective is to demonstrate an increase in proportion of HIV cases diagnosed during early stages of infection, defined as a CD4 count higher than 200 cells per cubic millimetre.

Ethics approval

Camden and Islington Community Research Ethics Committee, 18/11/2009, ref: 09/H0722/67

Study design

Pragmatic cluster randomised single-centre controlled trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type


Patient information sheet

Can be found at and


Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)


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 training in performing the rapid point of care HIV test
3. Setting up the operating procedure for HIV testing as an integrative part of the new patient health check
4. Confirmation of referral pathways for newly diagnosed patients into specialist care
5. Establishing the role of the HIV specialist nurse as the key figure to facilitate communication about newly diagnosed patients between clinicians including GPs and the HIV specialist team, the Virology lab and the researchers

Follow-up procedures:
Any patient with a reactive HIV rapid test will be seen by the GP immediately for information; 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 and the Department of Virology at Barts and The London NHS Trust at least fortnightly to minimise the loss of patients followed up in specialist care. If a patient fails to attend specialist follow up, the HIV research nurse will make appropriate attempts to contact the patient.

Laboratory assessments:
1. Rapid HIV test: The rapid HIV test will be performed using the INSTI HIV-1/HIV-2 Rapid Antibody Test (bioLytical Laboratories, Canada) according to the manufacturer's instructions. The INSTI test device has CE-marking and detects antibodies to the Human Immunodeficiency Virus Type 1 and Type 2. Briefly, 50 micro litres of blood drawn from a finger prick using a pipette is mixed with a Sample Diluent and poured onto a Sample Membrane. Signals are visualised by applying a Colour Developer onto the membrane and by de-staining the background using a Clarifying Solution. Results are available in 60 seconds. A single dot (control) on the Sample Membrane indicates a negative result; an additional blue test dot suggests HIV infection, and any other staining pattern including the absence of any signal indicates an invalid result. For further information, please see
2. CD4 counts and viral parameters including HIV viral load, clade and genotype of the virus

Laboratory assessments of immunological and viral endpoints specified in section of this protocol will be performed according to approved standard operating procedures.

Total duration of treatment and follow up:
For patients testing reactive, invalid or inderminate on the Rapid HIV Fingerprick test treatment and follow up could be between 2 weeks and 2 months depending on result. In cases where patients test non reactive, treatment will last only a few moments.

Control Surgeries:
No treatment. Control surgeries will be informed about the most recent specialist recommendations for HIV testing and receive support from the HIV specialist nurse throughout the study period.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Rates of new HIV diagnoses: numbers of rapid and standard HIV tests done in new patient health checks

Outcomes are measured quarterly.

Secondary outcome measures

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.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Barts and The London School of Medicine and Dentistry
E1 2AT
United Kingdom

Sponsor information


Queen Mary's University of London (UK)

Sponsor details

Joint Research and Development Office
5 Walden Street
E1 2AN
United Kingdom

Sponsor type




Funder type


Funder name

City and Hackney Primary Care Trust (UK) (ref: PMO 34B)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2015 results in:
2015 results in:

Publication citations

Additional files

Editorial Notes