Speaker Name Statement

Alison RodgerNone

Date April 2016

Alison RodgerUniversity College London

19-22 April 2016, Manchester Central

22nd Annual Conference of the British HIV Association (BHIVA)

Speaker Name Statement

Michael BradyNone

Date April 2016

Michael BradyKings College Hospital

19-22 April 2016, Manchester Central

22nd Annual Conference of the British HIV Association (BHIVA)

‘DIY Testing’

Michael BradyConsultant in HIV and Sexual Health, Kings College Hospital

Medical Director, Terrence Higgins Trust

Alison RodgerReader in Infectious Diseases, UCL

Consultant in Infectious Diseases/HIV, Royal Free

April 22nd 2016BHIVA, Manchester

Outline

• What is DIY testing

• Potential benefits and harms of HIV self-

testing (HIVST)

• What do we know?

• What do we not know?

• How will we get answers?

What is DIY Testing?

• A reactive HIVST does not provide a diagnosis: requires additional testing and linkage to care

• Many people have ST for other conditions, many with life altering and potentially devastating implications

• HIVST first proposed in the 1980s – concerns about individual response to reactive result in absence of effective treatment

• Illegal in UK between 1992 -2014

Self-Testing• Collects a specimen• Performs a test

• Interprets the result by themselves

Why do we need HIVST

PHE report (2015), Sigma Research (2009), Sadler KE Sex Transm Infect (2007), McDaid LM HIV Med (2016), UNAIDS Report (2015)

• High proportion of people living with HIV remain undiagnosed

– 47% globally (90-90-90 UNAIDS 2020 goals)

– Contributes disproportionally to new transmissions (60%-80%)

– UK: 14% MSM, 21% heterosexual people undiagnosed. Late diagnosis a significant problem, particularly in people of Black African ethnicity (55%)

• Testing frequency MSM less than recommended

– Never (28%), annually (55%), ‘higher risk’ testing 6 monthly (27% )

• Testing frequency people of Black African ethnicity

– Estimated 39% to 57% never tested

Global estimates (2014-15) of gap to reach UNAIDS 90-90-90 Targets

TAXI-KAB Study, Kirby Institute (2013) Suntharasamai PLOS ONE (2015)

Testing barriers in previous 12 months, Australian MSM

• Increase testing rates by removing structural and social barriers

– Distance, time, concerns with confidentiality, stigma (sexual orientation /HIV)

– Provide autonomy, privacy, confidentiality

Potential Benefits HIV-ST

• Reduce risk behaviours, potential for harm reduction strategies (disclosure/sero-sorting/positioning)

• Prevention Synergy: i.e. PrEP requires frequent HIV-testing which could be facilitated by HIVST, though test sensitivity on ART as yet unclear – especially for oral fluid ST

Potential Harms• Linkage to confirmatory testing

and care

• Coercion to test, violence

• Social and emotional harms to reactive test in absence of counseling

• Missed opportunity for STI screening and risk behaviour counseling

• Test performance – window period, low sensitivity, particularly with oral fluid ST in early infection or if on ART

Window of Detection for HIV, Based on Test Used

• CL sex following negative test (window period and increased STI transmission)

Jaspard, Plos One (2014), Suntharasamai PLOS ONE (2015), Thirumurthy (2016)

Products with Regulatory Approvals in the UK

OraQuick BioSure

Device 2nd gen 2nd gen

Specimen Oral fluid Finger-prick

Commercialavailability

Sold in USA. Plans for Europe unclear

Sold in UK & Europe

Regulatory Status

FDA, CE marked CE marked

Sensitivity 99.3% (98.4-99.7) 99.7% (98.9-100)

Window period 3 months* 3 months*

Specificity 99.8% (99.6-99.9) 99.9% (99.6-100)

Performance if 10,000 self-tests performed

Prevalence True Positive False Positive

High (2.0%) 200 2 (1:100)

Low (0.2%) 20 2 (1:10)

*Median time to reactivity 25-35 days based on published studies

Jaspard (2014), Branson (2011)

WHAT DO WE KNOW?

http://www.hivst.org/evidence-map

Evidence Collected to Date on HIVST

Acceptability of HIVST

www.hivst.org

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Acc

epta

bili

ty (

%)

Reporting studies 1-42

HIVST Acceptability in Key Populations

• Studies in high income settings mostly in MSM

• MSM participants found HIV-ST easy to perform and did so accurately

• High levels of acceptability in MSM (45-98%), ‘convenient and private’

• No differences identified by country, income, educational level Figueroa C, AIDS Behav (2015)

Preferences for HIV ST Attributes, Concerns and Linkage to Care

• High acceptability in MSM in high income settings for oral specimen - easier to perform and less painful

• Concerns about user error and low accuracy of ST (particularly oral sample), lack of counseling and HIVST not being free

• Linkages to care: few studies. Katz et al reported 2 diagnoses through HIVST: 1 immediate linkage, 1 delayed 2 months

Figueroa C, AIDS Behav (2015), Katz (2015)

Evidence of Harm• Systematic review, 300 papers: no serious adverse events with

variety of self-diagnostics (includes HIVST) - “very little evidence of any harm occurring in self-testing”

• Violence/coercion:

– US: MSM, 7 cases verbal aggression when testing sex partners, no physical violence

– Kenya: FSW and pregnant women, HIVST sex partner; physical partner violence (4), verbal (1)

– Malawi: Cluster RCT, 2.9% “forced to test”. No HIVST related partner violence or suicides were reported

• Increased risk behavior:

– No evidence of increased risk of STI or CL AI in iTest Seattle study

Brown et al (2014); Carballo-Dieguez (2012): Katz (2015), Choko (2015), Thirumurthy (2016)

http://www.hivst.org/evidence-map

Evidence Collected to Date on HIV-ST

HIV-ST Trials

HIV-ST Trials in Key Populations

HIVST RCTsInvestigator Year Population/

location

Test kit Study Design Outcomes

LSHTM, UNITAID/PSI, UCL, LSTM, CRP, WHO. HIV Self-testing Africa (STAR). Multiple studies planned.

2016-18 Malawi OraQuick Cluster Randomized Trial

to SOC or HIVST or HIVST+

home HIV care initiation

(n=5000)

Uptake of testing in each group[12 mths]. Disclosure of a positive HIV result . ART initiation rates

MacPherson, Corbett, Choko,

Wellcome Trust.

2010-2012 Malawi OraQuick Cluster Randomized Trial

community areas (n=14,

pop 16, 660) to facility-

based HIV care or home

HIV care. HIV-ST promoted

in all clusters.

Uptake HIV-ST high (76%), 75.8% shared

results with counselors.

Positive HIVST reporting to CHW was higher

in home HIV care cluster compared to

facility (6% vs 3.3%) as was ART initiation

(2.2% vs 0.7%)

Merchant et al, Rhode Island

Hospital

2015-16 Young Adult

MSM Rhode

Island, US

OraQuick Randomized to ST or blood based SS or standard of care (n=450 total)

Uptake of testing in each group[12 mths]

MacGowan et al. The

eSTAMP Study, CDC/Emory

2015-16 Internet-

recruited MSM,

US

OraQuick &

Sure Check

Randomized to 4 ST (2 oral,2 blood) or standard of care (n=3200 total)

Frequency of testing (12 mths). Linkage to care. Risk behaviour. Testing of partners and social networks

The FORTH Study, Kirby

Institute, Australia

2013-15 MSM, Australia OraQuick Randomized to 4 ST (alloral) or standard of care (n=350)

Frequency of testing (12 months). STI test

frequency, acceptability, use of tests

Stekler & Katz, University of

Washington (NIH). The iTest

Study

2012-14 MSM, Seattle,

US

OraQuick Randomized to ST (anynumber) or standard of care (n=230)

Number of HIV tests during follow-up (15 mth): 5.3 ST versus 3.6. STI diagnosis (5%ST versus 12%). CL AI at 12 months (21% ST versus 22%) and 15 months (29% ST versus 24%)

Policy and Practice (Implementation)

• WHO guidance (5 Cs)

– Consent, Confidentiality, Counseling, Correct results and linkage to Care

• Various models regarding programmatic approaches to HIVST

– Support

– Distribution

– Access to care

• Supervised vs unsupervised

• Clinically restricted vs non-clinically restricted

• Importance of national policy and regulated framework

• HIVST has potential to increase number of PLWHIV who know their status

• HIVST shares many characteristics with current approaches to HIV testing

• Key concerns regarding HIVST apply to other types of HIV testing and can be minimised

• Research is continuing but current evidence is limited and essential to develop a larger evidence base

• National policy and regulations can, and should, be adapted to include HIVST

Policy and Practice

WHO 2015 GL: http://apps.who.int/iris/bitstream/10665/179870/1/9789241508926_eng.pdf?ua=1&ua=1

Current Policy EnvironmentPolicies & Product(s) Licensed & Registered

Policies ExplicitlyAllowing HIVST

Policies Under Development

HIVSTAvailable

Informally+

HIVST Explicitly

Illegal

USA 2012 Australia South Africa* China Botswana

UK 2015 Kenya Zimbabwe Namibia Germany

France 2015 Hong Kong Malawi South Africa

South Africa* Zambia Russia

Brazil Brazil Tanzania

Belgium Peru Nigeria

Thailand

*South Africa allows HIVST kits to be sold through venues, except pharmacies. This policy is currently being reviewed

HIVST in the UK

• UK experience

– Legal since April 2014

– One available CE marked kit (privately)

– No data on how best to use in an NHS setting

• Post marketing surveillance

• NIHR funded study – qualitative focus group

HIVST Experience (UK)*

• 27,917 kits sold – April 2015 – Feb 2016

• 77% men

• 75.3% ‘non-metropolitan’ areas

• 50.4% never tested before

*Biosure post-marketing surveillance Brady M et al Self-testing for HIV: initial experience of the UK’s first kit BHIVA 2016

• 12 reports of invalid tests (0.04%)

• 6 reports of ‘false positives’

• Positive user feedback

– 97.5% would use the kit again

– 98.1% said it was easy to do

– 99.4% said it was easy to read

*Biosure post-marketing surveillance Brady M et al Self-testing for HIV: initial experience of the UK’s first kit BHIVA 2016

HIVST Experience (UK)*

PANTHEON(Prevention ANd Testing for HIV: Economics and

Outcomes of Novel Approaches*)

The main RESEARCH QUESTIONS are:

• Does provision of free HIV self-testing increase

rates of diagnosis in MSM?

• Which HIV prevention initiatives (alone and in

combination) for reducing HIV incidence are most

cost-effective?

*NIHR Funded Programme Grant (2015-2020)

Programme Component StudiesWorkstream 1: Feasibility Studies

•Systematic literature review

•Focus groups with MSM

•Manual and material development to support RCT design

•Process Evaluation to assess RCT interventions

Workstream 2: RCT

•RCT to assess impact of HIVST on early HIV diagnosis

•Qualitative interviews with men in RCT

Workstream 3: Modelling and Economic Evaluation to Assess Cost Effectiveness of Strategies for HIV Prevention in MSM

•Web based longitudinal study risk behaviours in MSM

•Identification of prevention strategies and costs and effects

•Model the cost-effectiveness of HIV prevention strategies

WHAT DON’T WE KNOW?

Research Gaps…..

1. Will HIV-ST increase the number of people who test, increase frequency of testing and result in earlier detection of HIV infection

2. Linkages to care

3. Potential for harm (compared to other HIV testing routes); do benefits outweigh harms?

4. How will HIV-ST influence sexual behavior and risk of HIV and other STI transmission

5. Cost-effectiveness

6. Key populations in high resource settings

7. Optimal service delivery models

1. Will HIV-ST increase the number of people who test, increase frequency of testing and result in earlier detection of HIV infection

2. Linkages to care

3. Potential for harm (compared to other HIV testing routes), do benefits outweigh harms?

4. How will HIV-ST influence sexual behavior and risk of HIV and other STI transmission

5. Cost-effectiveness

6. Key populations non-MSM in high resource settings

7. Optimal service delivery models

Research Gaps…..

Conclusions

• HIV-ST is likely to be acceptable but performance and integration with other support and clinical services important

• Less is known (and we need to understand) about HIVST in non-MSM groups in high resource settings

• Demonstrating impact on diagnosis rates, cost effectiveness and effective models of distribution will be key

• Support around diagnosis and facilitating linkage to care is essential

Acknowledgements

• PANTHEON Study Group

• Charlie Witzel, Peter Weatherburn, Fiona Burns, Tim Rhodes (WS1)

• Biosure UK: Gary Carpenter, Brigette Bard

• Cheryl Johnson, WHO

Question 1

• HIV self testing were same price or less it should be available on the NHS now

• HIV self testing is an untested intervention and should be used with caution

• HIV self-testing has the potential for harm and should not be encouraged