WHO consultation on HIVST and PrEP Presented by Rachel Baggaley WHO Meeting, 10 august 2017, Pretoria, South Africa

1. WHO consultation on HIV self-
testing and PrEP
Dr Rachel Baggaley and Dr Busisiwe Msimanga-Radebe, WHO
http://www.who.int/hiv/en/
www.hivst.org
10 August 2017
WHO Meeting –
Pretoria, South Africa

2. HIV testing and care continuum (2016)
UNAIDS/WHO estimates
The testing gap
>30 % people unaware they are living
with HIV
Inequity
continues - men,
adolescents and
key populations

3. Reactive results need confirmation by trained
tester using a validated national algorithm
What is HIV Self-Testing?
Collects Performs Interprets

4. WHO HIVST Strategy
• self-testers with a reactive
(positive) result need further
testing from a trained provider
• self-testers with a non-reactive
(negative) test result should
retest if they have been exposed
to HIV in the preceding six
weeks, or are at high ongoing
HIV risk.
• HIVST is not recommended for
people taking anti-retroviral
drugs, as this may cause a
false non-reactive result.
*Any person uncertain about how their self-test result, should be
encouraged to access facility- or community-based HIV testing

5. Directly assisted HIV self-testing
Trained peer or health worker could
provide a brief demonstration on how to
use the kit and how to interpret results
• Provide face-to-face assistance during
self-testing (optional)
• Instruction-for-use &/or included in
the kit:
‒ Pictorial/written
‒ Including a hotline number or a link
to a video
‒ Multimedia instructions (tablet)
‒ Remote support via SMS, QR code
or mobile messaging applicationsUnassisted HIV self-testing
Instruction-for-use included in the kit:
• Pictorial/written
• Including a hotline number or a link to a video
• Multimedia instructions (tablet)
• Remote support via SMS, QR code or mobile messaging applications
• Package inserts included in the kit

6. WHO Guidelines on HIVST-
December 2016
 5 RCTs (2012-2016) directly comparing
HIVST to HIV testing by a provider as
of July 2016
 25 studies on HIV RDT for self-testing
performance as of April 2016
• 125 studies on acceptability/feasibility
(including user values preferences) as
of July 2016
• 4 studies on cost/cost-effectiveness as
of July 2016

7. 5%
1%
10%
16%
33%
36%
0% 20% 40%
Multi-Region
SEAR
EUR
WPR
AMR
AFR
Region
3%
32%
32%
40%
Young people
General
Population
Other (Mixed,
HCW)
Key
Population
0% 20% 40% 60%
Population
Studies by Region, Population, Type of RDT
13%
7%
67%
13%
Null & N/A
Fingerstick
Oral fluid
Oral fluid & Fingerstick
Type of RDT

8. Advantages of HIVST
• Empowering
• Highly acceptable – to a range of
populations – inc men, partners,
adolescents and young people, key
populations
• Feasible and accurate
• Increases uptake and access to testing
• Increased frequency of testing
• Good linkage to care can be achieved
• No identifiable increased risk of social
harm & adverse events

9. New WHO recommendation
HIV self-testing should
be offered as an
additional approach to
HIV testing services
(strong recommendation,
moderate quality
evidence)

10. Where we are now
• Availability
• Experience
• Policy
• Future plans

11. HIV self testing is available
“informally” everywhere and formally in some countries

12. HIVST products
(ERP-D & WHO PQ)
Oral fluid HIVST pre-qualified July 2017
Blood-based HIVST in the pipeline

13. As of June 2017, 40 countries have a supportive policy for HIVST, and 48 countries are
planning to introduce HIVST as part of their national strategic plans

14. Key messages for users and implementers
Community awareness of the benefits and cautions about HIVST
• Use of approved HIVST kits
• with appropriate, validated, clear and concise instructions for use –
demonstrations and support tools may be particularly useful for rural populations
and those with low levels of education and literacy
• Clearly state positive results need further testing, provide
information on what to do after positive result
• Clearly state that HIVST should never be used when people are
taking ARVs (problem of false negative results)
• Make sure pre-test information and post-test counselling
accessible and available – inc linkage to community groups and clinical
services
• Some people will find HIVST difficult (esp initially) - Clear information
about what to do if someone can’t do a HIVST or get a invalid result

15. Key messages for users and implementers
Community awareness of the benefits and cautions about HIVST
• Integrate HIVST into comprehensive sexual health service
programmes and provide messages and information on tuberculosis,
STIs, viral hepatitis
• Realize demand creation role of HIVST for PrEP, ART and other
services
• HIVST (as for all testing) must be voluntary, coercion never
warranted
• Monitoring of any abuses of HIVST or adverse outcomes
essential

16. Next steps
Increasing community awareness
How to do this
• Events
• Media
• Literature, leaflets…… other
Which methods most appropriate in SA
Which groups need special focus
• Further information
• http://www.who.int/hiv/en/
• www.hivst.org

17. WHO recommendation for PrEP
Oral PrEP (containing TDF) should be offered as an additional prevention choice for
people at substantial risk of HIV infection as part of combination prevention
approaches
• Enabling recommendation
• Not population specific
– For people at substantial HIV risk (provisionally defined as HIV incidence > 3 per 100 person–years in
the absence of PrEP)
• Offer as an additional prevention choice
• Provide PrEP within combination prevention
– Condoms and lube
– Harm reduction
– HIV testing and links to ART
• Provide PrEP with comprehensive support
– Adherence counselling
– Legal and social support
– Mental health and emotional support
– Contraception and reproductive health services

18. 18
Why more focus on prevention options needed Global
HIV transmission persists
Treatment scale-up has ‘masked stagnation in the estimated annual number of new HIV infections’
.
Beyond the 90-90-90: refocusing HIV prevention as part of the global HIV response
Baggaley R, Dalal S, Johnson C, Macdonald V, Mameletzis I, Rodolph M, Figueroa C, Samuelson J, Verster A, Doherty M, Hirnschall G.
J Int AIDS Soc. 2016 Dec
Prevention Gap Report (UNAIDS), 2016: http://www.unaids.org/sites/default/files/media_asset/2016-prevention-gap-
report_en.pdf

19. Behavioral
Interventions
WHO rec 2012
Partner/Couples testing
WHO rec 2011
?testing
Coates T, Lancet
2000
Sweat M, Lancet
2011
WHO rec 1995
Male and female
Condoms &
lubricants
STI Treatment
Grosskurth H, Lancet 2000
WHO rec 2007
VMMC (Male
circumcision)
Auvert B, PloS Med 2005
Gray R, Lancet 2007
Bailey R, Lancet 2007
WHO rec 2012
"Treatment as
prevention"
U=U
Cohen M, NEJM, 2011
Donnell D, Lancet 2010
Tanser, Science 2013
Grant R, NEJM 2010 (MSM)
Choopanya K, Lancet 2013 (IDU)
WHO rec 2012,14, 15
Oral PrEP
WHO rec 2007,14
Post Exposure
prophylaxis (PEP)
Scheckter M, 2002
HIV
PREVENTION
?Mobile
Technologies
WHO rec 2004
NSP for PWIDs
WHO rec 2000, 09
OST for PWIDs
Kaplan, JAIDS, 1994
Allen S BMJ, 1992
HIV prevention

20. HIV testing
New
positives
Negatives 'high risk'
'Not interested'
Negatives
'low risk'
Negative
Negatives 'high risk'
interested in PrEP
PrEP
Engagement with services
Condoms and lube, STI, HBV, HCV screening, re-testing , partner
testing, vaccination, family planning, GBV issues
tackle HIV stigma, educate about TasP
PrEP services
Re-engage
positives
Who dropped out of care
A catalyst for much broader benefits beyond PrEP
New ART
initiation

21. PrEP not for all; not for ever
Total
population
of people
at
substantial
risk
Seeks
services
'meets
criteria
' for
offer
of PrEP
Accept
PrEP
Eligible
for PrEP
Starts
PrEP
Continue
on PrEP
Re-starts
PrEP
“Not using PrEP”: other HIV prevention option needed
“Not using PrEP”: other HIV prevention option needed

22. WHO PrEP guidance
Preventing HIV during
pregnancy and breastfeeding in
the context of PrEP
Technical brief
http://www.who.int/hiv/pub/toolkits/pr
ep-preventing-hiv-during-pregnancy/en/
Who Implementation Tool for
Pre-exposure Prophylaxis of HIV
Infection
Résumé des modules en Française

23. WHO PrEP Implementation Tool
• Modular
• Different
audiences
• Different setting
• Different pops
• Suggestions not
recommendations
• Much uncertainly
• Learn as
implement
• Frequent updating
anticipated

24. Concerns about PrEP
Cost
Equity
Safety
Drug resistance
Behavioral
disinhibition
Pregnancy and
hormonal
contraception
Evidence to support PrEP use….
Can be cost-effective (esp. if generic drugs used) and "PrEP
candidate" appropriate.
People at substantial HIV risk are often medically underserved and
have few other effective HIV prevention options.
No differences in any adverse events or grade 3 or 4 adverse
events when comparing PrEP to placebo, but will need to monitor
creatinine before and during PrEP use.
Low levels <1 case in 1000 PY PrEP use. PrEP is expected to reduce
HIV incidence, including primary and secondary drug resistance,
thereby decreasing drug resistance overall.
No evidence of changes in condom use or number of sexual
partners as a result of PrEP use.
No drug-drug interactions with hormonal contraception.
No increased adverse pregnancy-related events.
Key issues as we move from recommendation →
implementation

25. • PrEP works, when taken (adherence is a critical predictor)
• Demand is growing, although uptake varies according to setting
• PrEP brings people at high HIV risk into services with benefits beyond
PrEP
– HIV testing uptake
– Opportunity to screen for STIs, FP, vaccinate for HepB
• Not all people want PrEP and not all the time. Other prevention must
be available
• To support effective and equitable PrEP use, services need to address
structural factors and behavioural issues
• PrEP is not just a biomedical intervention, but also a bio-behavioural
one
It is important to adopt a public health, human rights and people-centred
approach when offering PrEP to those at substantial risk of HIV.
Key messages for PrEP users and implementers
Community awareness of the benefits and cautions about PrEP

26. Put the power in the people,
put the pill in theirs palms
Sheena McCormack, July 24, 2017
26