Self testing seminar overall

HIV Self-testing Seminar26 November 2013


What’s legal now: Home-sampling pilot &

implications

Is there demand for self-testing?Terrence Higgins Trust survey, December 2010 (650 respondents)

35% of plwHIV (167) thought they’d have tested earlier.This rose to 44% of those diagnosed late.

62% of negative respondents would consider using self-testing kits. (65% of gay men, 72% of Africans)

51% think they would test more often. (60% of gay men, 67% of Africans)

3% of negative gay men had used an illegal kit.

HIV Home Sampling

THT Project January 2013 10,000 kits send out 60% return rate Nearly 100 people diagnosed Dry blood spot test Acceptability and usability

HIV Home Sampling

HIV Home Sampling

• 4,477 male • 379 female• 4,043 homosexual• 648 heterosexual• 3,870 white • 986 BME • 351 mixed white• 139 African

Requests from Scotland

• Total orders – 439 (4.5% uptake on total UK figures)

• Total returned - 342

• Return Rate - 77.9%

• Total Positives - 2

• Positivity Rate - 0.58%

THT Home Sampling Pilot – 2013Returns from Scotland

THT Home Sampling Pilot – 2013Returns from Scotland

Ethnic Group Female Male TOTALWhite British 13 277 290

White Irish 2 7 9

Any Other White Background 1 20 21

Mixed White and Asian 2 2

Any Other Mixed Background 1 1

Pakistani 2 2

Other Asian 1 1

African 2 1 3

Chinese 3 3

Any Other 1 1

Not Stated 7 9

TOTAL 20 322 342

Home Sampling - implicationsFills an important gap in portfolio of

testing opportunities across statutory, private & third sectors

Increased discretion = increased accessibility

Provides support when receiving a reactive result

One size doesn’t fit all – e.g. African population

Need for other options in addition to this

The future:Technology will continue to

developOpportunities for new servicesMore choices for peopleWe all have a role to play in the

future

Thank YouRobert McKay

[email protected]

mailto:[email protected]


HIV SELF-TESTING KITS:WHAT’S THE CHANGE?Gareth BrownScottish Government

Background UK Department of Health publicly

announced (August) intention to change legislation around HIV testing kits.

HIV Testing Kits and Services Regulations 1992 made it illegal to advertise, sell or supply an HIV testing kit to a member of the public.

Self-testing kits have been available since 1992 despite the ban - likely that people are already buying poor quality kits online.

House of Lords Select Committee’s: No Vaccine, No Cure: HIV and AIDS in the UK (September 2011). “The committee also propose the legalisation and regulation of home testing”

Announcement follows the Food and Drug Administration (FDA) in the US taking the step of approving the OraQuick In-Home HIV Test for sale directly to Americans in July 2012.

Why Change?

No Vaccine, No Cure:“There are legitimate concerns about getting those who test at home to access services, but regulation would ensure that messages about the importance of accessing care are communicated.”“Home testing equipment is available over the internet: one survey showed that 0.5% of the 180,000 people surveyed (900 people) had their last test at home, whilst 5.9% said home testing would be their preferred method in the future.”Home testing would give people greater responsibility and control over their own health. “People should be given the opportunity to take control of their lives and find out about their problems."

Why Change?

No Vaccine, No Cure:Home testing could also mean earlier access to testing—one survey found that 35% of those canvassed who were infected with HIV thought they would have been diagnosed earlier if home testing had been availableThe ban on HIV home testing kits, as laid out in the HIV Testing Kits and Services Regulations 1992, is unsustainable and should be repealed.

Regulation of Kits

“A plan should be drawn up… to license kits for sale with appropriate quality control procedures in place. The licensing regime must make sure that the tests are accurate.” No Vaccine, No Cure: HIV and AIDS in the UK

The change in legislation is an important step to ensuring such kits are regulated, accurate and safe. They will be subject to existing regulatory European wide CE quality standards.

HIV testing kits placed on the European market must meet legal requirements which set out specific requirements for self-testing devices, including instructions for correct use. In the UK, the Department of Health has said all kits would be subject to strict regulatory control by the Medicines and Healthcare products Regulatory Agency (MHRA).

This is important for HIV self-testing where a full blood test by a clinician will be needed to confirm a reactive (positive) result from a self-test

OraQuick In-Home HIV Test: 1 in 12 false negatives? Will regulation drive improvements in accuracy/quality?

Scottish Government Role 1992 Regulations are a reserved matter – that means that

it is for the UK Government to change the legislation. Scottish Government has no role.

But Scottish Government does support the legislative change and is working with the other UK countries to implement and support the change.

Potential benefits: Stigma: some people are reluctant to use existing testing

services. Timeliness: 50% of HIV infections in Scotland are diagnosed

late, meaning they are potentially harder to treat. Uptake: self-testing could increase overall uptake of testing

and reduce undiagnosed HIV. Patient choice/patient-centred: will give people more

choice on how to get tested and access treatment sooner if needed, and reduce the risk of new HIV infections

Reducing costs to the NHS: A recent Canadian study showed that on average the cost of treating HIV was two-and-a-half-times higher for someone diagnosed late than for those diagnosed in a timely fashion.

Challenges

What are the challenges with legalising the sale of self-testing kits? Interpreting the result and what to do afterwards – what

information is needed in each kit? Will users necessarily be able to understand? (Window periods)

Possible incorrect usage? 2007 Singapore study* found that even though almost 90% found the kit easy to use and instructions easy to understand 85% failed to perform all steps correctly and 56% had invalid results because of incorrect test performance.

Confirmatory testing: How do we ensure that the pathways into more formal testing services are as easy as possible for patients to navigate, especially when they may be in shock?

Getting people into care as soon as possible after a positive test result. How do we offer help and support to those people who are especially isolated? 90% of people in treatment across Scotland have undetectable viral load – and there are good retention rates in care. Getting into treatment at the appropriate time has major benefits.

What other challenges?*User Acceptability and Feasibility of Self-Testing With HIV Rapid Tests, Lee et al, JAIDS, 1August 2007

Next Steps

SG will meet colleagues from other UK countries to look at how we might support implementation of the change in legislation.

DH has indicated that there will not be a national helpline but beyond that no clear decisions have been made.

Change in law expected to come into effect from April 2014 and we expect CE-marked kits to come onto the market later in 2014.

It is ultimately up to individual NHS Boards to decide how they want to use the change in the law.

Scottish Government position is that availability of self-testing kits may provide opportunities to increase testing rates, especially in vulnerable communities, and we would be interested to hear of new initiatives.

But what advice, if any, does the SG/Chief Medical Officer need to provide to NHS Boards and others?

“The discussion we are having now about HIV home testing kits is exactly the same discussion we had 20 years ago about pregnancy

tests.”



Diagnosing the Undiagnosed. The development of a non invasive, rapid HIV self test

Brian Reid

Vice President, International

OraSure Technologies Inc.

29

Reaching the unreachable – novel testing means

Providerbased

HCTCommunity

testing

Home testing

Providerbased

Selfsampling

testing

Supervised

self

InPharmacy

testingtesting

Anonymous

self

Laboratorytesting

•Despite widespread availability of blood tests, significant number of individuals

have never had an HIV test

30

• Highly accurate (>99%) test results in 20 minutes

• Sensitivity: 100%* Specificity: 99.8%*

• Over 25 million units sold worldwide

• 30 month shelf life

• Used in diverse settings

OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test

Confidential & Proprietary

Rapid-format test that detects HIV antibodies in oral mucosal transudate (OMT)

OMT contains high concentration of IgG antibodies.

31

Oral Fluid – Specimen Collection

32

SIMPLE RESULT INTERPRETATION:

One line = NEGATIVE

Two lines = POSITIVE*

OraQuick® In-Home HIV Test- Result Interpretation

Negative

Reactive Control

Line

Positive

Reactive HIV-1/2

Test Line

* Labeling describes positive result as ”you may have HIV”


OraQuick In Home HIV Test History


34

Challenges Maximizing Diagnostic Efficiency of Home Tests

• Bastian LA et al. (1998). Meta-analysis of home pregnancy tests:– Sixteen home pregnancy tests (5 studies)– Aggregate sensitivity in laboratory studies: 91%

(84%-96%)– Aggregate sensitivity in self-test studies: 75% (0.64-

0.85)

• De La Fuente et al. (2012). Self-test study using fingerstick HIV test:– Only 92% of users obtained a valid result

35

OraQuick In-Home HIV Test System – Outer Box


36

Label Comprehension Study Results

Product use (self-selection)

Time test can detect HIV (window period)

What to do if anxious about taking the test

Not okay to use under 14 years of age

Okay to use if pregnant

Not okay if previously diagnosed with HIV

Wait 30 minutes after eating / drinking

Not okay to expose to cleaning reagents

Last step before timing test

Minimum time test result can be read (>20 minutes)

Time when test result is no longer valid (>40 minutes)

What to do if test result is Positive

What to do if you are not sure of your result

What to do if your test result is Negative

What to do if you have any questions

98.8%

98.6%

97.2%

92.8%

91.8%

88.4%

96.2%

91.4%

84.6%

96.4%

98.2%

97.0%

97.4%

82.2%

99.2%

Questions on self-selection Questions on performing the testQuestions on interpretation of the test results


37

OraQuick In-Home HIV Test System – Kit Contents

Test stand

Test Device

Pouched Device

Pouched Developer Vial

Stepwise Instructions

Pre & Post-Test Informational Booklet

Package Insert


38

Phase III Trial: Unobserved Self-Testing Study

• Visit 1: Subject enrolled and blood drawn for lab testing

• Visit 2: Subject self selected (or de-selected) and took possession of OraQuick In-Home HIV Test kit

• Visit 3: Subject returned to site and provided self-test result according to standard script

– Site staff provided laboratory results to the subject

– Appropriate counseling was provided based on laboratory results

– Additional information collected on subject intent

• Visit 4: Scheduled if required based on follow-up testing

• Cross sectional demographics


39

Performance of the In-Home HIV test in the Hands of the Consumer(Phase III Study of Unobserved Self-Testing)

Accuracy(4990/4999)

99.82%(95% CI: 99.66% - 99.92%)

Test System Failure Rate*(56/5055)

1.11% (95% CI: 0.84% - 1.44%)

Sensitivity(88/96)**

91.67%(95% CI: 84.24% - 96.33%)

Specificity(4902/4903)

99.98%(95% CI: 99.89% - 100.0%)

NPV(4902/4910)

99.84%(95% CI: 99.68% – 99.93%)

PPV(88/89)

98.88%(95% CI: 93.90% - 99.97%)

*Proportion of tests that user failed to get a positive or negative result ** Eight HIV positive individuals reported their HIV self-test result as negative


40

Intention Responses: HIV Positive Subjects

0

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4

Scale of 0 to 4

Pe

rce

nta

ge

Likelihood to get post-test counseling

Likelihood to follow-up with doctor or clinic for treatment

Likelihood to Recommend

Not at all likely Definitely

(N=101)

(N=101)

(N=100)

Source: Phase III studyConfidential & Proprietary

41

Intention Responses: HIV Negative Subjects from High Prevalence Sites

0

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4

Scale of 0 to 4

Per

cen

tag

e

Likelihood to get tested again for HIV

Likelihood to use a rapid HIV home test

Likelihood to use HIV home test to screen new sexual partners

DefinitelyNot at all likely

(N=3903)

(N=3902)

(N=3901)


42

Low Levels of Anxiety Reported Among HIV Positive Subjects Identified During Unobserved Self-test Study

• Of the HIV positive subjects, most (68.6%) were described as “calm” by site staff during counseling and discussion of HIV positive results

• Among HIV-positive subjects, there were no anxiety-related adverse events that required intervention by site staff when HIV positive results were discussed


43

Key Findings from Clinical Trial of Unobserved Self-Testing (n= 5055)

• Ninety nine percent (99%) of users successfully obtained a test result (positive or negative)

• Eighty eight (88) subjects of previously unknown status self-identified as HIV positive through use of the in-home test (1.7%)

– Eight HIV positive subjects reported their self-test result as negative to the clinical sites (calculated sensitivity = 88/96= 92%)

• Predictive value of the test was very high (NPV= 99.8%; PPV=98.9%)• Excellent observed specificity (4,902/4,903; >99.9%) • Excellent overall accuracy* (4,990/4999; >99%)• Strong benefit/risk for product approval:

– Predicted number of individuals identified (who otherwise wouldn’t have tested)

– Estimated number of forward transmissions prevented

* Not an FDA approved label claim

Source: Phase III study Confidential & Proprietary

44

OraQuick HIV In-Home Support Center

• Designed and developed specifically for use with the OraQuick® In-Home HIV Test • Operational 24/7/365

• Information management system for consistent responses, referral to care & complaint intake

• Designed to allow the caller to remain anonymous

• Scripts and materials were developed in conjunction with representatives with practical counseling experience


OraQuick Phone Queue Goal Queue 1 Test Results 100% answered immediatelyQueue 2 Test Usage 100% within 20 seconds Queue 3 Orders/Inquiries 80% within 30 seconds

45

Reported Positive Test Results, Referrals and Consumer Complaints

• ~400 calls per week• 212 callers reported a positive result after using the OraQuick In Home HIV test• 677 callers received referrals

• Reasons for declining a referral include following up with their own HCP or testing facility

• Other reasons for referrals (outside of confirmatory test) include inquiries for free testing, clinics, HIV Specialists, state hotline referrals, additional STD information

• <0.1% complaint rate launch to date576 101 111

Referrals

Positives

Data is sourced from OraQuick Inquiry System and is through September 30,2013 Confidential & Proprietary

46

Projection of Positives Identified

Theoretical Projection of Total Number of Positives Identified

Based on Consumer Support Center Activity

212 Positives* Identified via Consumer Support Center

% of Positives Calling Support Center**

1% 5% 10%

Projected Total Number of Positives

21,200 4,240 2,120

Positives as Percent of Units Sold to date

10% 2% 1%

*Positives captured launch through 9/30/13** Based on prelaunch research indicating that most (96%) consumers receiving positive result will contact their healthcare professional; ~200K units sold launch through September 2013

• We believe the prevalence rate with the OTC consumer is between 1-2%• This is consistent with the data generated in the clinical study of a 1.7%

prevalence rate


47

Web Site Support: www.OraQuick.com

• Engage• Learn about the OraQuick

Self-Test

• Education• Video tutorials• Warnings and precautions

• Support• Find Counseling and Care

• Sales• Access to Purchase

OraQuick® In-Home HIV Test

1

2

2

2

3 5 4


48

National Campaign

• Designed to de-stigmatize testing and drive product awareness

• Launched via Advertising, Public Relations and retail promotion.

“Testing for HIV is Everyone’s Thing”

“Knowing is the Best Thing”


49

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

4 wkending

10/27/12

4 wkending

11/24/12

4 wkending

12/22/12

4 wkending1/19/13

4 wkending2/16/13

4 wkending3/16/13

4 wkending4/13/13

4 wkending5/11/13

4 wkending6/8/13

4 wkending7/6/13

4 wkending8/3/13

4 wkending

08/31/13

Un

its

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000Total US

Avg Units per Week

OraQuick® Retail Sales Trend

Source: Nielsen data, Oct 2012-Aug 31, 2013

-2%

+48%

+27%

+51%+4%

+11% +1%+2%

+9%

-9%

• Over 200K units sold launch to date

• E-Commerce accounts for an additional 9% in units

-6%


50

Core Buyers Emerging

Urban

MSM AA

Single College Towns

Hispanic American

Asian American

Secondary

• Consistent with Expected Source of Volume by Consumer Segment– MSM and AA Estimated to contribute 86% of Volume

Source: Spectra & Experian research data


51

Public Health Programs

• Several Public Health and Advocacy groups have purchased OraQuick® In-Home HIV Test kits

• Primary uses in Public Health settings relate to:– Social Networking: Provide tests to high risk individual

to give to other individuals living in high risk communities

– Prevention for Positives: Provide tests to individuals who have tested positive to give to partner(s)

– Missed Testing Opportunities: Provide test to individuals who have declined a test at a clinic, mobile site, event, etc., giving them an opportunity to test at home


52

Overall Summary

• OraQuick In Home HIV Test approved in July 2012– Approval driven by strong risk/benefit argument

• Consumer support resources to maximize linkage to health services and providers; system functioning extremely well

• Product up take continuing to build, as awareness builds among high risk populations

• Believed to be providing substantial public health benefit in terms of number of positives identified


1) Who do you think could most benefit from home test kits?

2) What would appropriate access to these kits look like? Online? Pharmacies? Third Sector? Supermarkets?

3) What would a positive experience of using these kits be?

4) What are the risks of self-tests and how are they best mitigated?

5) Which agencies should have responsibility for what?


Self testing seminar overall

Health & Medicine

home hiv test

hiv testing

confidential

gay men

scottish government

home testing

test study

testing kits