5. 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 selftesting 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.
6. 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
9. Requests from Scotland
439 (4.5% uptake on total UK figures)
•
Total orders –
•
Total returned - 342
•
Return Rate -
•
Total Positives - 2
•
Positivity Rate - 0.58%
77.9%
12. THT Home Sampling Pilot – 2013
Returns from Scotland
Ethnic Group
White British
Female
Male
TOTAL
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
1
3
Chinese
3
3
Any Other
1
1
Not Stated
7
9
322
342
African
TOTAL
2
20
13. Home Sampling - implications
Fills
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
14. The future:
Technology
will continue to develop
Opportunities for new services
More choices for people
We all have a role to play in the future
18. 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 : N
o
Va c c ine , N Cure : HI a nd ADS in the
o
V
I
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.
19. Why Change?
N Va c c ine , N Cure :
o
o
“The re a re le g itim a te c o nc e rns a bo ut g e tting
tho s e who te s t a t ho m e to a c c e s s s e rvic e s ,
but re g ula tio n wo uld e ns ure tha t m e s s a g e s
a bo ut the im p o rta nc e o f a c c e s s ing c a re a re
c o m m unic a te d . ”
“Ho m e te s ting e q uip m e nt is a va ila ble o ve r
the inte rne t: o ne s urv e y s ho we d tha t 0 . 5 % o f
the 1 8 0 , 0 0 0 p e o p le s urve y e d (9 0 0 p e o p le )
ha d the ir la s t te s t a t ho m e , whils t 5 . 9 % s a id
ho m e te s ting wo uld be the ir p re fe rre d m e tho d
in the future . ”
Home testing would give people greater
responsibility and control over their own
health. “Pe o p le s ho uld be g ive n the
o p p o rtunity to ta ke c o ntro l o f the ir live s a nd
find o ut a bo ut the ir p ro ble m s . "
20. Why Change?
N Va c c ine , N Cure :
o
o
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 available
The ban on HIV home testing kits, as laid
out in the HIV Testing Kits and Services
Regulations 1992, is unsustainable and
should be repealed.
21. Regulation of Kits
“Ap la n s ho uld be d ra wn up … to lic e ns e kits fo r s a le with a p p ro p ria te q ua lity
c o ntro l p ro c e d ure s in p la c e . The lic e ns ing re g im e m us t m a ke s ure tha t the
te s ts a re a c c ura te . ” 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?
22. 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
23. 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*Us e r Acmajor benefits. o f Se lf-Te s ting With HIV Ra p id Te s ts , Le e e t a l, JAIDS , 1 Aug us t 2 0 0 7
has c e p ta bility a nd Fe a s ibility
24. 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?
25. “The discussion we are having now about HIV home testing kits is exactly the
same discussion we had 20 years ago about pregnancy tests.”
28. 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
•Despite widespread availability of blood tests, significant number of individuals
have never had an HIV test
Laboratory
testing
Provider
based
HCT
Community
testing
Provider
based
In
Pharmacy
Home
testing
testing
Self
sampling
Supervised
Anonymous
self
self
testing
testing
29
30. OraQuick ADVANCE® Rapid HIV-1/2 Antibody
Test
• 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
Rapid-format test that
detects HIV antibodies
in oral mucosal
transudate (OMT)
OMT contains high
concentration of IgG
antibodies.
Confidential & Proprietary
30
32. OraQuick® In-Home HIV TestResult Interpretation
SIMPLE RESULT
INTERPRETATION:
One line = NEGATIVE
Two lines = POSITIVE*
Reactive
Control
Line
Reactive
HIV-1/2
Test Line
Negative
Positive
* Labeling describes positive result as ”you may have HIV”
Confidential & Proprietary
32
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
34
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 test
Questions on interpretation of the test results
Confidential & Proprietary
36
37. OraQuick® In-Home HIV Test System –
Kit Contents
Test stand
Stepwise
Instructions
Package
Insert
Pre & Post-Test
Informational Booklet
Pouched
Confidential & Proprietary Device
Test
Device
Pouched
Developer Vial
37
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
Confidential & Proprietary
38
39. Performance of the In-Home HIV test in the
Hands of the Consumer
(Phase III Study of Unobserved Self-Testing)
Accuracy
(4990/4999)
Test System Failure Rate*
(56/5055)
Sensitivity
(88/96)**
Specificity
(4902/4903)
NPV
(4902/4910)
PPV
(88/89)
99.82%
(95% CI: 99.66% - 99.92%)
1.11%
(95% CI: 0.84% - 1.44%)
91.67%
(95% CI: 84.24% - 96.33%)
99.98%
(95% CI: 99.89% - 100.0%)
99.84%
(95% CI: 99.68% – 99.93%)
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
Confidential & Proprietary
39
40. Percentage
Intention Responses: HIV Positive
Subjects
100
90
80
70
60
50
40
30
20
10
0
0
Not at all likely
1
2
3
Definitely
Scale of 0 to 4
Likelihood to get post-test counseling
(N=101)
Likelihood to follow-up with doctor or clinic for treatment
Likelihood to Recommend
Source: Phase III study
4
(N=101)
(N=100)
Confidential & Proprietary
40
41. Intention Responses: HIV Negative
Subjects from High Prevalence Sites
100
90
Percentage
80
70
60
50
40
30
20
10
0
0
Not at all likely
1
2
3
Scale of 0 to 4
Likelihood to get tested again for HIV
(N=3903)
Likelihood to use a rapid HIV home test
(N=3902)
Likelihood to use HIV home test to screen new sexual partners
Source: Phase III study
Confidential & Proprietary
4
Definitely
(N=3901)
41
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
Source: Phase III study
Confidential & Proprietary
42
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
43
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
Queue 1 Test Results
Queue 2 Test Usage
Queue 3 Orders/Inquiries
Confidential & Proprietary
Goal
100% answered immediately
100% within 20 seconds
80% within 30 seconds
44
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
Referrals
576
•
101
111
Positives
<0.1% complaint rate launch to date
Data is sourced from OraQuick Inquiry System and is through September 30,2013
Confidential & Proprietary
45
46. Projection of Positives Identified
• 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
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
Confidential & Proprietary
46
47. Web Site Support: www.OraQuick.com
2
•
Engage
• Learn about the OraQuick
Self-Test
•
Education
• Video tutorials
• Warnings and precautions
•
Support
• Find Counseling and Care
•
2
Sales
• Access to Purchase
OraQuick® In-Home HIV
Test
1
3
5
2
4
Confidential & Proprietary
47
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”
Confidential & Proprietary
48
49. OraQuick® Retail Sales Trend
+9%
20000
18000
Avg Units per Week
16000
+51%
+1%
5000
-9%
+4%
-6% 4500
4000
+27%
14000
Units
+11%
Total US
+2%
3500
+48%
12000
10000
3000
2500
-2%
8000
2000
6000
1500
4000
1000
2000
500
0
0
4 wk
4 wk
4 wk
ending
ending
ending
10/27/12 11/24/12 12/22/12
•
•
4 wk
ending
1/19/13
4 wk
ending
2/16/13
4 wk
ending
3/16/13
4 wk
ending
4/13/13
4 wk
ending
5/11/13
4 wk
ending
6/8/13
4 wk
ending
7/6/13
4 wk
ending
8/3/13
4 wk
ending
08/31/13
Over 200K units sold launch to date
E-Commerce accounts for an additional 9% in units
Source: Nielsen data, Oct 2012-Aug 31, 2013
Confidential & Proprietary
49
50. Core Buyers Emerging
•
Consistent with Expected Source of Volume by Consumer Segment
– MSM and AA Estimated to contribute 86% of Volume
MSM
AA
Urban
Secondary
Single
Confidential & Proprietary
College
Towns
Source: Spectra & Experian research data
Hispanic
American
Asian
American
50
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
Confidential & Proprietary
51
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
52
54. 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?
