HIV Point of Care Testing

Coventry City Council

Public Health Department

HIV PharmacyPoint of Care Testing

Date Of Implementation January 2016

Review Interval One year

CONTENTS

1. SUMMARY

The Coventry HIV Point Of Care Testing Pharmacy pilot aims to increase the number of HIV tests undertaken in Coventry, especially with at risk groups such as the black African population and Men who have Sex with Men (MSM). This method of increasing HIV testing has been demonstrated as effective in Dudley where 12 pharmacies undertook 446 HIV tests in an 8 month period in 2014.

The INSTI HIV-1/HIV-2 AntibodyPoint Of Care blood spot Test(POCT) is the screening test for the HIV antibody to be used in the Coventry Pharmacy HIV pilot project. Patients whose blood samples give reactive results mustattend the Integrated Sexual Health Service for a further blood test to have their HIV diagnosis confirmed. This document describes the procedure for ordering, delivery, and storage of the HIV POCT kits, as well as providing clinical guidelines for staff,and details of how to promote the project (which is a requirement of participation).

2. HEALTH AND SAFETY INFORMATION

All staff must be conversant with Universal Precautions, Control of Substances Hazardous to Health Regulations (COSHH) 2000, Management of Health & Safety Regulations 1992 and the local policy for the management of body fluid exposures to staff.

Staff must have successfully completed a short training session to undertake HIV POCT.

Blood must always be regarded as potentially infectious. Therefore gloves must be worn when undertaking this procedure.

All members of the pharmacy team undertaking the actual testing must be Hepatitis B immune.

The INSTI HIV-1/HIV-2 Antibody kit: Each kit contains 1 test for single use only.

• The kits should be stored between 15 and 30 degrees Celsius.

• Please note the kits have individual expiry dates. They must be checked prior to use.

3. OPERATIONAL PROCEDURES

Ordering the INSTI HIV-1/HIV-2 Antibody kit

The INSTI HIV-1/HIV-2 Antibody kits will be provided viathe Coventry Public Health Department. Please contact to order more kits

4. INCLUSION AND EXCLUSION CRITERIA

Inclusion Criteria

All patients requesting an HIV test who have self-identified as at risk (see below for risk groups)

OR

Patients who have been advised to have a test by a health professional (GP practices will be signposting new registrations for an HIV test).

Risk Groups

As recommended by the UK National HIV testing guidelines (2008) the risk groups who should be testing in the pharmacy scheme are:

• all men who have disclosed sexual contact with men
• all female sexual contacts of men who have sex with men
• all patients reporting a history of injecting drug use and their partners (refer to drug and alcohol services if appropriate)
• all men and women known to be from countries with a >1% prevalence i,e, those from sub Saharan Africa see for a list of countries with a HIV prevalence over 1%
• male or female sex workers, or men or women who disclose frequent access to sex workers * or access to sex workers
• all men and women who report sexual contact abroad or in the UK with individuals from countries with a >1% prevalence i.e. those from sub Saharan Africa see for a list of countries with a HIV prevalence over 1%*

The above risk groups are identified in national guidelines. However, anyone who has had unprotected sex and would like a test should be offered an HIV test.

List of countries with HIV prevalence >1%

Exclusion Criteria

• patients presenting for healthcare where HIV, including primary HIV infection, enters differential diagnosis (need to be referred to GP)
• patients diagnosed with an STI, (or who request STI test/screen)(need to be referred to sexual health services)
• sexual partners of men and women known to be HIV positive(need to be referred to sexual health services)
• pregnant women who refused antenatal screening
• people requesting HIV post-exposure prophylaxis (HIV PEP)(need to be referred to sexual health services, or A&E if out of hours)
• those already known to have HIV (need to be referred to sexual health services)
• anyone tested in the past 3 months with no subsequent history of potential exposure
• pregnant women who have had an ante-natal HIV test
• patients who have symptoms of sero-conversion illness(these individuals should be referred straight to the Integrated Sexual Health Service)

5. TRAINING

Pharmacies must ensure that all staff involved in HIV testing have attended the free HIV POCTtrainingprovided by the Public Health Department (no payments for backfill can be made). Training will cover information about HIV, the use of point of care tests, communication(including dealing with stigma)data collection to access available funding and requirements regarding quality assurance. All appropriate staff in the pharmacy, including reception staff, should be aware of the project. A full outline of thetrainingcan be found in Appendix 2.

6. PRE-TEST DISCUSSION

Pre-test discussions will be undertaken by Pharmacy staff that haveattended the HIV training provided by Coventry City Council.

The discussion should include:

• Reason for test request
• Verbal informed consent
• Confidentiality
• Testing method - test result will be available during this visit
• Reactive (preliminary positive) result will need to be confirmed by a further blood test at the Integrated Sexual Health Service (result available in 1 working day)
• Explain the importance of evaluating the project and ask the patient to complete a short questionnaire provided by the Commissioner

7. TAKING THE POINT OF CARE TEST

1. Wash hands prior to the procedure to reduce risk of cross-infection
2. Check kit expiry date, open the kit and gather the materials together.
3. Choose the finger tip of the middle, ring or index finger (whichever is the least calloused)
4. Massage the finger to allow the blood to move to the fingertip.
5. Wear disposable gloves to protect the patient and yourself from blood borne infection
6. Clean the finger tip with alcohol swab & allow to dry
7. Position the patient’s hand palm up to ensure ease of access and at waist level or lower
8. Place the lancet off-centre against the finger tip and press firmly to pierce the skin
9. Dispose of the lancet in a sharps container
10. Hold the patient’s finger & apply gentle intermittent pressure to the base of the punctured finger to increase the flow of blood
11. Hold the capillary tube horizontally between your thumb & forefinger & put the tube to the drop of blood
12. Fill the tube with blood to between the 2 marked lines to ensure an adequate sample
13. The amount of fingerprick blood is critical
14. Apply a cotton wool ball firmly to the puncture site & ask the patient to hold it in place to prevent further bleeding

8. TEST PROCEDURE

1. The specimen collected should be tested immediately
2. Apply the blood sample from the capillary tube to the Sample Diluent vial (solution 1) by firmly pressing the top bulb. Rinse the capillary tube by drawing back and releasing the solution in the vial
3. Recap the vial and invert several times to mix
4. Tear open the pouch containing the INSTI membrane unit without touching the centre well and place on a flat surface.
5. Pour the entire contents of Solution 1 into the well. The solution should be absorbed in less than 30 seconds.
6. Resuspend the Colour Development vial (solution 2) by inverting to mix the solution thoroughly
7. Add the entire contents of Solution 2 to the centre of the membrane well
8. Open the Clarifying Solution (solution 3) and add entire contents of Solution 3 to the centre of the membrane well
9. Immediately read the result while the membrane is still wet. Do not read the results if more than 5 minutes has elapsed since adding the Solution. Repeat the test with a completely new kit.

9. INTERPRETATION OF TEST RESULTS

Non Reactive

One blue dot that is clearly discernable above any background tint should appear on the membrane. This is the Control Spot and shows that the test has been performed correctly. No reaction should be visible at the test spot which is located below the control. A non-reactive result indicates that antibodies to HIV-1 /HIV-2 were not detected.

Reactive

Two blue dots that are discernable above any background tint indicate that the specimen contains HIV-1 and /or HIV-2 antibodies. One dot may be darker than the other. Following a reactive rapid test result, a venous sample of blood must be taken and sent to the lab for HIV confirmatory testing (this will be done by the Integrated Sexual Health Service).

Invalid- Invalid tests should be retested using a completely new kit.

The test is invalid if any of the following occur:

• There is no dot on the membrane
• The test dot appears with no control dot
• Uniform tint across the membrane
• Only blue specks across the membrane

Indeterminate

The test is indeterminate if a faint background ring appears on the membrane. Retest with a completely new kit.

Visuals shown below:

10. RECORDING THE TEST OFFER AND RESULT

The test offer and results must be recordedby the pharmacy and provided to the management agency (to be confirmed by the project manager in Public Health) to enable the pharmacy to claim the funding of £10 per test performed,

• Age, gender, sexuality and country of origin of patients having the HIV POCT
• HIV POCT undertaken
• Lot number and date of expiry of test
• Test result
• Whether a rapid referral to ISHS for a confirmatory test was made
• Reason for test request
• Results of the patient questionnaire (to be input onto the pharmacy system).

Funding also requires staff involved in the pilot to undertake a 30 minute interview/focus group regarding their experience of their involvement in the project.

11. GIVING THE RESULT AND POST-TEST DISCUSSION

Non-reactiveResult

Patients whose test result is non-reactive can be confidently advised of their result. The following must also be discussed:

1. Advise patients inside risk window period (within 3 months of exposure) to return for a follow-up test.Patients in the following groups should be advised to return to the pharmacy for a repeat test as detailed:

Ref:

• men who have sex with men (MSM) – annually or more frequently if clinical symptoms suggestive of sero-conversion or every 3 months if having unprotected sex with new or casual partners.
• injecting drug users – annually or more frequently if clinical symptoms suggestive of sero-conversion
• patients from high prevalence area- annually or more frequently if on-going high risk exposure i.e. if having unprotected sex with new or casual partners

1. Recommend a sexually transmitted infection screen (through referral to ISHS).
2. Give advice regarding risk reduction/behaviour change including the use of condoms and where to access free condoms and
3. Discuss post-exposure prophylaxis (PEPSE)

Reactive Result

ALL reactive results MUST be confirmed by the patient attending the Integrated Sexual Health Service for a further blood test (Appendix 3)

Void/Invalid result

A void/invalid result should be repeated within the appointment.

Post Test Discussion for reactive tests

The post test reactive discussion will be undertaken by the trained staff within the pharmacy

• Assess patient’s response to reactive result

• Assess level of support available to patient
• Discuss risk reduction to prevent onward transmission
• Explain the confirmatory test process
• Arrange appointment at the Integrated Sexual Health Service for confirmatory test.

12. Quality assurance

All pharmacies participating in the project must agree to undertake a quarterly quality assurance operator test. On a quarterly basis the National External Quality Assurance Service(NEQAS) provided by Public Health England (UK NEQAS Micro) will send each pharmacy participating in the project two samples which the operator must test for HIV antibodies using an INSTI test. The results must be forwarded via an internet based database or fax to NEQAS and the samples and tests disposed of through the clinical waste system operated by the pharmacy. Registration with NEQAS will be paid for.

All pharmacies must keep a lotand date of expiry record for all INSTI tests undertaken as part of performance monitoring.

Each new batch of INSTI tests must also be tested with samples supplied via the Project Manager at the start of the pilot and each time the pharmacy is provided with a new batch of tests. The samples must be kept refrigerated and can be kept for up to 1 year.

1. Promoting the project

All pharmacies participating in the project must visibly display agreed posters and patient leaflets in order to encourage service users to self-identify that they need an HIV test.

All pharmacies must also promote the project with local GP surgeries, who should be referring patients newly registering with the practice.

All members of staff must be aware of the project to support easy access to the HIV test for service users self-identifying that they need an HIV test.

1. Evaluating the project

All staff participating in the projectwill take part in a 30 minute forum/interview to discuss acceptability and accessibility of the project to staff and patients

All staff participating in the project to provide a short questionnaireto patients accessing the service and to input results onto the pharmacy system.

Appendix 1:

Proposed Training: HIV testing in primary care

Target audience: Pharmacists working in participating pharmacies

Aim: To ensure that pharmacy staff administering the HIV Point of Care Test are able to offer testing in a consistent, appropriate and safe manner to all eligible patients

Duration: 2 hours

Material covered:

• Background on HIV (chronic and treatable disease)
• Background on pilot (local picture, need for early diagnoses)
• HIV and stigma, talking about HIV
• Who to test
• Pre-test conversation
• How to operate the test
• Interpreting and communicating the results
• Care pathways for reactive tests
• Project evaluation
• Claiming the funding

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APPENDIX 3 - REACTIVE HIV POCT

REFERRAL PATHWAY FROM PRIMARY CARE INTO INTEGRATED SEXUAL HEALTH SERVICES (ISHS)

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