Rachel Baggaley,

Coordinator, Key Populations and Prevention Unit

WHO HIV Department

Global Fund

Geneva, Switzerland

2 June 2016

Realizing the potential of HIV

self-testing – a summary of

the latest evidence Cheryl Johnson,

Technical Officer

WHO HIV Department

What is self-testing?

Collects Performs Interprets

Reactive results need confirmation by health provider

What is HIV Self-Testing (HIVST)?

Test for Triage HIVST within algorithm

• A single rapid diagnostic test

• Not a definitive test for those who test +ve

• Emphasis on HIV diagnosis at health facility (start at A1)

• Triage – prioritize linkage following testing as appropriate

Perform test for triage A0

Link to HIV testing for

diagnosis, care & treatment

A0 + A0 –

Report HIV- Recommend

repeat testing as needed

Continuum of HIVST models

Outlines models, priorities, policy issues &

evidence gaps

Technical considerations for HIVST &

encourages countries to conduct

pilots/demonstration projects

• Global Fund Operational Note to support

implementation research pilots (2 June

lunchtime seminar)

Most current information available on

HIVST.org

Current WHO guidance on HIVST

Source: WHO HTS GL 2015; UNITAID 2015

Prospective WHO Guidelines Timeline

• 6 June HIVST TWG Meeting

• 17-18 July GL 2016 Meeting

– Meeting in Durban to review synthesis of evidence

• 1 Dec 2016 Launch of HIVST GL

– Planned release of normative guidance and considerations

– Critical to have HIV RDTs for self-testing available

• Q3/Q4 2017 HIVST Implementation GL

– Planned operational tool for HIVST

Available Formally

…& Informally

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

Acceptability & Willingness

Source: 1 www.hivst.org , Evidence Map, accessed 15 Feb 2016 – 51 reporting studies

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

PSI/UNITAID STAR Project Catalysing HIVST in Southern Africa

Source: WHO, 2015 http://www.who.int/hiv/mediacentre/news/unitaid_hiv-self-testing/en/

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

PSI/UNITAID STAR Project

Current HIVST implementation in Zimbabwe

• Modelling suggests HIVST is cost-effective if priced at US$3 per test

• Pilot studies show HIVST is acceptable, appealing and accurate

• Female sex worker (FSW) uptake ~50% - 2/3 HIV- FSW interested in HIVST & 2/3

HIV+ FSW said they’d prefer HIVST to health worker diagnosis alone.

• 93% users read tests correctly & 88% said it was easy to use (adults urban and

rural settings). Demonstration, videos and validated IFUs were key.

• UNITAID/PSI STAR Project started in Zimbabwe in March 2016

• Offering HIVST in rural, urban and peri-urban settings to reach 16+ people: KP,

men, VMMC, young people, 1st-time testers

• 8,095 HIVST kits were distributed between 23 March and 23 April 2016

• 61% distributed in men

• MoHCC formed HIVST TWG & is leading planning & guideline development

process.

Highest uptake among young

people & adolescents

• 76% in months 1-12

• 74% in months 13-24

• 44% first-time testers

• ~90% returned kits with self-

completed questionnaire

20-29 16-19 30-39 40-49 50+

Age Group (years)

Months

Source: Choko et al 2015

Year 2

Year 1

Men

Women

Uptake Amongst All Residents in Malawi Since HIVST Made Available

Source: Lippman 2011; Gray 2013; Venetuneac 2009; Katz 2015

Increased Frequency

HIVST increased frequency of HTS

among MSM in USA

0%

10%

20%

30%

40%

50%

60%

70%

80%

HIVST Standard HTS

In Brazil, MSM who were less

frequent testers and considered

testing but failed to test were more

likely to prefer HIVST.

In Australia 2/3 HIV-negative MSM

said they’d test more frequently if

HIVST was available.

Models suggest increases in

frequency using HIVST among

MSM, especially in settings with low

testing coverage, could have a

public health impact.

Linkage

Source: 1 MacPherson 2014; 2 Choko 2015; 3.

Thirmuthy 2016; 3. Figueroa et al. 2015

Evidence is limited, but promising1,2,3

•Especially when coupled with a proactive

approach (e.g. home-based assessment, ART

initiation)

•80-100% of MSM report they would link to

further testing and care, if they had a reactive

self-test result4

Higher 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 Test Home Group

or Home Option

(8,194)

Facility-Based Test Facility Group

or Facility-Based

(8,466)

Parent Trial Participants

Adverse Events

HIVST can be empowering.

• A 2014 lit review reported no serious adverse events as a result of

self-testing for multiple diseases and conditions, including HIV1.

• No suicide or self-harm & in Malawi trial showed no intimate-partner

violence2,3,4

• As with all HTS, clear messages, monitoring & reporting systems

are important to identify and address issues when and if they occur.

Information and messages for communities, particularly for vulnerable

populations.

• Tools include: Hotlines, Mobile phones & SMS, Community-

based monitoring systems, post-market surveillance systems,

etc.

Source: 1 Brown et al 2014; 2 Desmond 2014: 3. Kumwenda 2014; 4Choko 2015; 5. Thirmurthy 2016

Performance Can be Good

Table 2a. Calculated sensitivity and specificity of RDTs used for self-testing with assisted approach (n=12)

Table 2b. Calculated sensitivity and specificity of RDTs used for self-testing with unassisted approach (n=18)

*HIV prevalence for sensitivity and specificity calculations. n/a: not available, a: One participant was on ART, this person tested negative via self -test and positive in confirmatory testing.

*HIV prevalence for sensitivity and specificity calculations. FWB: fingerstick/whole blood, a: four participants were on ART, they tested negative via self-test and positive in confirmatory testing.

Sensitivity as high as 98.6% (95% CI 96.6 – 99.5%) & Specificity as high as 100% (95% CI

99.9 – 100 %)

Clinical utility risk-benefit HIVST HIV prevalence 1%

Clinical utility risk-benefit HIVST HIV prevalence 5%

Clinical utility risk-benefit HIVST HIV prevalence 10%

Clinical utility risk-benefit HIVST HIV prevalence 60% - FSW in South Africa

Clinical utility risk-benefit HIVST

Analysis suggests HIV RDTs for self-testing have more benefit than risk

– particularly when utilized to reach people at high risk, w/ low HTS

coverage & who may not otherwise test.

Risk of false reactive/false non-reactive self-test results can be mitigated

easily through clear messaging & quality systems, such as:

• Clear messages that HIVST does not provide an HIV+ diagnosis

• Clear messages on importance of frequent retesting, as

recommended by WHO for people at high on-going risk (e.g. every 3 to 6

mo.).

• Use of evidence-based strategies to facilitate linkage to further

testing, prevention, treatment and care

• Clear and concise IFUs &/or videos designed for HIVST to guide users

on how to perform the test and interpret the results.

Current Policy Environment Policies &

Product(s)

Approved for

HIVST

Policies

Explicitly

Allowing HIVST

Policies Under

Development

HIVST Available

Informally

USA 2012 Australia Namibia Namibia

UK 2015 Kenya Peru Russian Federation

France 2015 China Thailand United Republic of

Tanzania

Brazil 2015* Hong Kong SAR Zambia Nigeria

Macau SAR Zimbabwe Peru

Malawi* Belgium Uganda

Rwanda Ukraine

South Africa* Malaysia

NEW

NEW

In Brazil it HIVST not yet available in pharmacies, anticipated for later in 2016. In South Africa HIVST is available in pharmacies but MoH is in process of setting regulatory standards.

WHO/UNITAID landscape (Dec 2015)

• Currently being updated in collaboration with PSI

& BMGF

• 15 RDTs for HIVST identified, 3 approved by founding

member of GHTF, none WHO PQed yet (1 product

submitted dossier for PQ)

• Sales volumes increasing, but are relatively small

• Costs range from:

• US$ 28-40 (sale in high-income countries)

• US$ 3.50 – US$ 16 (for research low- & middle-income

countries)

• US$ 4-10 (sale informally in low- and middle-income

countries)

Preliminary estimate for demand for HIVST could be

at least 4.8 M & as high as 88 M RDTs in 2018

HIV RDTs for HIVST in the market All information is provided by manufacturers (UNITAID/WHO Landscape Dec 2015)

Manufacturer Assay name SENS SPEC Specimen Approval Status Price Per Test

(US$)

Autotest VIH

(AAZ Labs, France)

100% 99.8% Whole

blood

CE marked 25-28 (to

consumer)

Biosure HIV Self Test

(Biosure, UK)

99.7% 99.9% Whole

blood

CE marked 38-43 (to

consumer)

OraQuick In-Home HIV Test

(OraSure Technologies,

USA)

100% 99.8% Oral fluid CE marked NA

OraQuick In-Home HIV Test

(OraSure Technologies,

USA)

91.7% 99.9% Oral fluid FDA 40 (to

consumer)

Current implementation of HTS not enough to get to 90.

Strategic and efficient approaches are needed to expand HTS and increase

coverage among high risk populations who may not otherwise test

Public health response lags behind public demand—and we need to catch up.

Self-testing is not new. But it is an additional tool to create demand for, not

substitute, HIV testing services.

WHO guidance on HIVST on the way, and implementation research underway

Get going. Use what we have today and urgently work toward quality assured, ERP-D

and WHO PQed, low cost products for resource limited settings & pops who can benefit

most.

Think big. We need visionaries & champions; we need to stimulate technological

advances, better tests & innovations in implementation

Conclusions

Rachel Baggaley, Carmen Figueroa, Shona Dalal, Michel Beusenberg and Theresa

Babovic, WHO HIV Dept, Geneva

Anita Sands, Robyn Meurant, Willy Urassa and Irena Prat WHO EMP, Geneva

Carmen Perez Casas and Wale Ajose, UNITAID

Karin Hatzold and Petra Stankard, PSI

Elizabeth Corbett and Augustine Choko, London School of Hygiene and Tropical

Medicine, MLW, Wellcome Trust, Blantyre, Malawi

Acknowledgments