Rachel Baggaley, MBBS, MScWHO Geneva

Overview of HIV Self-testing: What We Know & Where to Go

Bill and Melinda Gates Foundation, Meeting on the Status & Future of HIV Self-Testing27 February 2015

Source: UNAIDS, Gap report 2014

Why are we talking about HIVST?

100%

0%

20%

40%

60%

80%

100%

PLHIV PLHIV who know theirstatus

PLHIV on ART PLHIV virally surpressed

Covered Not covered

Source: UNAIDS, Gap report 2014

Why are we talking about HIVST?

100%

45% 39%29%

0%

20%

40%

60%

80%

100%

PLHIV PLHIV who know theirstatus

PLHIV on ART PLHIV virally surpressed

Covered Not covered

Source: UNAIDS, Gap report 2014

Why are we talking about HIVST?

There is a testing gap.

55%

0%

20%

40%

60%

80%

100%

PLHIV PLHIV who know theirstatus

PLHIV on ART PLHIV virally surpressed

Covered Not covered

Source: UNAIDS, Gap report 2014

Proposed UNAIDS “90-90-90”

100%90% 90% 90%

5%

0%

20%

40%

60%

80%

100%

PLHIV PLHIV who know theirstatus

PLHIV on ART PLHIV virally surpressed

Covered 2020 Covered 2025 Not Covered

Source: UNAIDS, Ambitious treatment targets, 2014

Source: Choko et al PLoS Med 2011, Mavedzenge CID 2013, HIVST Technical Update UNAIDS 2014

Barriers to Achieving the First 90Key populations and vulnerable groups lag behind

• Poor access to and uptake of HTC services among men, health workers, key populations, adolescents, couples/partners, people 50+ , poor and rural populations, and other vulnerable groups

Cultural, structural and health system barriers persist• E.g. stigma and discrimination, policies such as “age of consent” laws, cost

of seeking services, long lines, lack of privacy and confidentiality, and concerns and reports of poor quality HIV testing

Poor linkage to prevention, care and treatment from HTC • In PITC & community-based HTC, linkage is low—opportunities missed• Need for innovative & supportive interventions

Positive results need confirmation

What is HIV Self-Testing (HIVST)?

Credits: David Stanton, Vincent Wong, Cheryl Johnson, Matthew Rosenthal

Available Formally & Informally

Policy Environment Changing Rapidly Policies &

Product(s) Licensed & Registered

Policies ExplicitlyAllowing HIVST

Policies Under Development

HIVST Available Informally+

HIVST Explicitly Illegal

USA 2012 Australia South Africa* China Botswana

UK Zimbabwe Namibia Germany

Kenya Malawi South Africa

EU** France Russia

Hong Kong SAR Zambia Tanzania

South Africa* Brazil

Peru

*South Africa allows HIVST kits to be sold through venues, except pharmacies. This policy is currently being reviewed+Primarily based on anecdotal reporting, informal sale in different countries may be under-estimated.**EU policy allows countries to decide to make Class D medical devices, including HIVST, available over-the-counter in member states.

Sample Type Oral fluid

Sens/Spec Sensitivity = 91.7% ; Specificity = 99.97%

SRA Status FDA-approved for self-testing

Price $30-$40 (currently only sold in US)

ManufacturerDescription

• $68M in US revenues in 2012, $20M international revenues• Primarily focused on oral fluid testing/sample collection• Also provide oral tests for HCV, and are working on Ebola test

Product Description

• First HIV home-test approved by FDA• Access to 24-hour counseling line provided with purchase• Results in 20 minutes, with 20 minutes accuracy window

Test Algorithm

1. Swab upper and lower once gums with test stick (either side)2. Put test stick in the test tube and wait 20min3. Remove test stick to see results; Compare test stick with pictures in booklet

Ease Of Use Features

• Less invasive sample type: no need to draw blood• Reduced number of steps: no need to transfer sample or add buffer• Longer time limit for reading the results: 40min

OraQuick® In-Home HIV Test (by OraSure) is the only FDAapproved product for self-testing—none are WHO pre-qualified

Source: FDA 2012, WHO 2014, slide courtesy of CHAI, 2014

12

Product (supplier) Specimen BusinessObjectives Regulatory Status Other RDTs from

Manufacturer

• Aware™ 2.0(Calypte, USA)

Oral Fluid • No info available In process of obtaining FDA approval

• Aware HIV-1/2 OMT

• Asante HIV Self Test(Sedia, USA)

Oral Fluid • No info available No info available • Asanté HIV-1/2 Oral Fluid Rapid Test

• DPP HIV1/2 (self test version) (Chembio, USA | Fiocruz, Brazil*)

Oral FluidWhole Blood

• No info available In process of obtaining FDA approval

• HIV 1/2 STAT-PAK• SURE CHECK HIV 1/2• DPP HIV 1/2

• Self Test(Developer in Toronto, Canada)

Whole Blood Wanting to sell it in Africa

• No info available • No info available

• Self Test(Buchanan, USA)

Whole Blood Wanting to sell it in Africa

• No info available • No info available

• Self Test(Alere, USA)

Whole Blood Target SSA market Process devo. readyby 2015

• Determine

• AtomoRapid(AtomoDiagnostics, Aus)

Whole Blood Wanting to sell it in Africa

In process of obtaining FDA approval

• AtomoRapid

Sure Check HIV-1/2(Biosure, UK)

Whole Blood Target UK No info available o No info available

• Self-test(AAZ labs, Nephrotek , France)

Whole Blood Wanting to sell in France, Francophone Africa

In process of obtaining CE approval

o No info available

Source: FDA, WHO and expert interviews, CHAI 2014

1

2

3

4

5

* Fiocruz Brazil: has a technology transfer agreement with Chembio for local production of oral fluid tests

6

7

8

OVERVIEW OF PIPELINE PRODUCTS FOR HIV SELF-TESTING

9

Source: WHO March 2014 supplement & UNAIDS/WHO Short Technical Update 2014

Many Possible Models

Source: 1 Young 2014; 2 Marlin 2014; 3 Mugo & Murungi forthcoming; 4 Tucker forthcoming; 5 Choko 2015; 6 Desmond 2014; 7 Kumwenda 2014; 8 Gaydos 2011; 9 Gaydos 2013; 10 Pai 2014 11 Corbett 2014; 12 Dong 2014: 13 Carballo-Dieguez 2012; 14 Ngure 2014

• Smart vending machines voucher programmes 1,2 –partnering with bathhouses & gyms in USA

• Pharmacies & key populations in Kenya3

• Via Internet & e-commerce sites in China4

• Youth & adolescent HIV testing programmes?5

• Couples and partner HTC6,7

• Kiosks, SMS, tablets and smartphone assisted HIVST8,9,10,11,12

Novel Approaches on Horizon

Sample Type Not specified: both oral fluid and whole blood

Sens/Spec Not applicable

SRA Status Not applicable

Price Free / Open source

ManufacturerDescription

• Developed by Victoria Royal Hospital (Montreal, Canada)• Dr Pant Pai has 15 years of experience with infectious diseases• Funded by the Gates Foundation• Winner of the international 2013 Accelerating Science Award Program (ASAP)

Product Description

• HIV self-screening strategy and app• Users are guided through a confidential process of self-testing, which contains

information, instructional videos, a 24 hour help line and confidential linkages to care and counselling

• Works on Android devices, but researchers are working on an iOS version, as well as expanding the number of language

Ease of Use Features

• Reduced user-error: clear step-by-step instructions to take the rapid test• Improved results interpretation: guidance on interpretation• Improved linkage to care: post-test counseling and 24 hour help line

HIVSmart (by Dr. Nitika Pant Pai) is a self-screening mobile app that assists with end-to-end performance of a rapid test

Source: Pai 2014, courtesy of CHAI, 2014

• WHO HIV self-testing evidence map

• See HIVST.org

• Purpose is to identify and log evidence geographically to better synthesize information

• Currently 74 studies catalouged, and work is on-going

Overview of Evidence Available

1

2

2

6

16

18

27

0 20 40

Mixed

Young People

VulnerablePopulations

HealthWorkers

Other

GeneralPopulation

KeyPopulations

1

4

8

10

24

27

0 20 40

SEARO

Multi-country

EURO

WPRO

AFRO

AMRO

221

1

3

1245

842

2

0 50

200120022003200420052006200720082009201020112012201320142015

Population

74 studies catalogued

Region Publication Year

Overview of Evidence Available

HIVST in Asia WPRO & SEARO

11 studies from Asia (5 China, 1 Singapore, 1 India, 4 Australia)

• Most among Key populations, primarily MSM reporting barriers to HTC

• 20% MSM surveyed in China report self-testing for HIV – 1/3 obtain kits on Internet1

• 15% of MSM in China who took an HIVST were confirmed HIV positive2

Source: 1 Han 2014; 2 Tao 2014; 3 Marley 2014;4 Lee 2007, www.hivst.org , evidence map, accessed 19 Feb 2015

Acceptability of HIVST varies, but is generally high.

Source: 1 www.hivst.org , evidence map, accessed 19 Feb 2015

0%

20%

40%

60%

80%

100%

Studies mostly among MSM in high-income settings

• Desire HIVST over-the-counter & via Internet

• Convenient & private nature is appealing

• More research on other KP groups & in resource-limited settings needed!

0% 20% 40% 60% 80% 100%

Chakravarty 2014

Wong 2014

Marley 2014

Ochako 2014

Gray 2013

Xun 2013

Chen 2010

Bavinton 2014

Bavinton 2013

De la Fuente 2013

Katz 2012

Greacen 2013

Carballo-Diéguez 2012

Lippman 2014

FSW MSM

Source: Figueroa et al. forthcoming, WHO 2015

ModerateLow High

HIVST Also Acceptable Among Key Populations

0%

25%

50%

75%

100%

1 6 12 1 6 12 1 6 12 1 6 12 1 6 12

20-2916-19 30-39 40-49 50+Age Group (years)

Months

Source: Choko 2015

Uptake Amongst All Residents Malawi Since Self-testing Made Available

MenWomen

0%

25%

50%

75%

100%

1 6 12 1 6 12 1 6 12 1 6 12 1 6 12

20-2916-19 30-39 40-49 50+Age Group (years)

Months

Source: Choko 2015

MenWomen

Uptake Amongst All Residents Malawi Since Self-testing Made Available

0%

25%

50%

75%

100%

1 6 12 1 6 12 1 6 12 1 6 12 1 6 12

• 76% in months 1-12

20-2916-19 30-39 40-49 50+Age Group (years)

Months

Source: Choko 2015

MenWomen

Uptake Amongst All Residents Malawi Since Self-testing Made Available

0%

25%

50%

75%

100%

1 6 12 1 6 12 1 6 12 1 6 12 1 6 12

Highest uptake among adolescents

• 76% in months 1-12

• 74% in months 13-24

• 44% first-time testers

• ~90% returned kits with self-completed questionnaire

20-2916-19 30-39 40-49 50+Age Group (years)

Months

Source: Choko 2015

Year 2Year 1

MenWomen

Uptake Amongst All Residents Malawi Since Self-testing Made Available

Accuracy can be good, especially within supervised HIVST• Sensitivity ≥ 91.7% & specificity ≥ 97.9%1,2

But, can be poor—especially with inappropriate products, poor or no instructions-for-use & without support• Poorer accuracy in unsupervised HIVST and high level of user

errors reported3,4,5,6,7

• Unsupervised approaches with good instructions & user-friendly, have higher accuracy8,9 than those without these measures.

Poor accuracy among people using ART, particularly with oral fluid-based HIV RDTs7,10

Source: 1 Pant Pai 2013; 2 FDA 2012; 3 Lee 2007, 4 Peck 2014, 5 Mevedzenge 2014, 6 de la Fuente 2012, 7 Pai2013; 8 Dong 2014; 9 Ng 2012; 10 Jaspard 2014

Accuracy

HIVST may be cost-effective• In Zimbabwe would result in

saving $20 million over 50 years, with modest impact on public health

Cost of HIVST to consumers & consumer willingness to pay varies—question of cost to users is an issue

0

10

20

30

40

50

60

USD

$

Willingness to Pay Among Key Populations

Studies, n=8

Cost Effectiveness & Willingness to Pay

11.6

16

19

18

40

15

50

7

Linkage

Source: 1 MacPherson 2014; 2 Choko 2014; Figueroa Guerro forthcoming

Evidence on linkage to care is limited, but appears promising positive1,2

• Especially when coupled with a proactive approach

• 80-100% of MSM report they would link to further testing and care, if they had a reactive self-test result3

Higer ART among Home Self-test Clusters than Facility-based

MacPherson 2014 (Malawi)

181 Participants initiating ART

63 Participants initiating ART

8,403 Participants not initiating ART

8,013 Participants not initiating ART

Home-Based TestHome Group

or Home Option(8,194)

Facility-Based TestFacility Group

or Facility-Based(8,466)

Parent TrialParticipants

Adverse Events• No serious adverse events for self-testing for multiple diseases and

conditions, including HIV, reported in literature1

• Some studies have documented potential issues:

• verbal confrontations among MSM2

• 1 participant in a study said they would coercively test someone3

• HIVST study reports that ~3% of people felt ‘persuaded’ coerced/”persuaded”—however nearly all would recommend HIVST4,5,6

• Couples report that discordant self-test result can be challenging 5,6

• Monitoring and reporting systems are few, important to develop and implement such systems

Source: 1 Brown et al 2014; 2 Carballo-Dieguez 2012: 3 Katz 2012; 4 Desmond 2014: 5. Kumwenda 2014; 6 Choko 2015

Solutions

KP & Other Vulnerable Groups

Consultations , research & engagement with transgender people, people who inject drugs, sex workers and young key populations in all settings—and MSM in resource limited settings; as well as adolescents, youth, men, 50+ , and other vulnerable populations

Costs & Cost-Effectiveness

Research on cost to health systems and implementation, as well as costs to consumers (depending on model)—answer question of substitution

Optimize Service Delivery Research on what the best approaches and models are , considering populations and contexts, and what supportive supplies and information is needed

Accuracy Accuracy in the hands of untrained users and with and without support, and instructions for use, within a replicable model

Linkage Demonstrate effective and scaleable models to support linkage to prevention, care and treatment

Low Cost & Quality Products

Demonstrate demand and market potential and size to industry, improve on existing target product profile to increase market entry

Risk & Harm Weighed Against Benefits

Better quantify any potential risk or harm and better quantify added public-health value of HIVST

Policy & Regulations

• Develop WHO guidelines• Use evidence to encourage national policy change and regulatory standards,• Identify regulatory pathway for product licensing and registration, & WHO pre-

qualification pathway• Develop & implement monitoring & reporting systems, including post-market

surveillance

Evidence Gaps

PSI/UNITAID STAR Project: Catalysing HIVST in Southern Africa

Countries

Malawi

South Africa

Zambia

Zimbabwe

Implementation-research Partnership Tackling Market Barriers by:

• Multiple sites, models, & populations• Normalizing HIVST in Southern Africa • Providing evidence for scale-up• Developing WHO Guidelines • Encouraging policy change• Enabling the regulatory environment• Shaping market to reduce barriers &

increase entry of low-cost HIVST products available for purchase & on recommended diagnostic commodities list

• Evidence is growing and appears promising—however evidence gaps remain and need to be addressed

• Momentum is building, policy change and desire for WHO guidance is growing

• Important to press ahead with building evidence & creating pathways to move ahead, with a focus on covering present knowledge gaps

Conclusions

Cheryl Johnson, WHO HIV Dept, Geneva, Switzerland

Elizabeth Corbett and Augustine Choko, London School of Hygiene and

Tropical Medicine, MLW, Wellcome Trust, Blantyre, Malawi

Frederic Seghers, Clinton Health Access Initiative

Carmen Figueroa Guerro, National School of Public Health. Instituto de

Salud Carlos III

Acknowledgments