1. Overview of the New Guidelines on HIV Self-Testing and Partner Notification What You Need to Know
29 November 2016
Key Populations & Innovative Prevention Unit
WHO HIV Department -

2. Scale-up of Diagnosis of PLHIV Over Time
Average % of PLHIV Identified for Top 30 Countries*, Yearly, Starting 2001
Steep increase:
Ramping up the number of facilities and introduction of Provider-Initiated testing
Decelerated increase:
High hanging fruits are more difficult to reach via traditional strategies
Slow start:
Initial VCT efforts
(Voluntary Testing)
Too early perhaps…maybe not include?
Explain X-axis and that this is start of epidemic to Y 26
Means or medians, how did they calculate the average of all 30 countries ? Ask FS.
Projection suggests, on current trajectory,
it will take ~25 years for countries to identify 90% of PLHIV.
* By size of the epidemic Source: Courtesy Frederic Seghers, CHAI Input data via UNAIDS Aidsinfo; DHS Statcompiler – projections via CHAI NMOT modeling

3. Scale-Up of HIV Testing Services
From 2005 – 2015, there was a sharp increase in HIV-positive diagnoses in Africa
From 2010—2014, > 600 M people received HTS in 122 low- and middle-income countries – nearly half all tests were in Africa.
In 2005, 12% people who wanted an HIV test were able & 10% PLHIV in Africa knew their status.
Source: WHO 2015; WHO 2016

4. Global Progress Toward the First 90, 2015
40% of PLHIV still remain undiagnosed worldwide
> 80% of all diagnosed PLHIV are on treatment
Let me start by saying we have made a tremendous amount of progress, particularly considering that in 2005 it was estimated that only 10% of PLHIV in Africa were aware of their status.
However, this is a figure that sadly something that we are all too familiar with at this conference – only 57% of people with HIV have been diagnosed. Meaning that approximately 11.9 million people living with HIV who did not know their status.
Source: UNAIDS, 2016 – based on 2015 measure derived from data reported by 87 countries, which accounted for 73% of people living with HIV worldwide; 2015 measure derived from data reported by 86 countries. Worldwide, 22% of all people on antiretroviral therapy were reported to have received a viral load test during the reporting period.

5. Progress toward the first 90 by region, 2015
62%
When we look across regions we see some great progress in Asia, Europe and Latin America achieving 60% or more – however in others we see we are far from achieving global goals; requiring more to be done to catch-up urgently.
Eastern &
southern Africa
Asia & the Pacific
Eastern Europe & central Asia
Latin America & the Caribbean
Middle East & North Africa
Western &
central Africa
Source: UNAIDS, 2016

6. New adult HIV infections globally, 2015
~1.9 M new adult HIV infections in 2015
44% new HIV infections are among key populations and their partners
Globally we see key populations continue to be affected by HIV – with 36% of all new adult infections in 2014 among key populations and their clients and partners – who often have the least access to testing and health services and the lowest testing coverage. New projections estimate about 44% of new
Source: UNAIDS, Data is for populations 15 years of age and above.

7. Much testing in ANC, even in low and concentrated epidemics
Women
Make Up Approximately
70% of Those Tested in 2014
Much testing in ANC, even in low and concentrated epidemics
Source: WHO 2015, 76 reporting low and middle income countries. Data is for populations 15 years of age and above.

8. Proportion people never tested for HIV, 2013-16
Source: DHS reports DHS Statcompiler . Data is only for men and women years of age

9. ~90% of the world’s HIV-positive adolescents (10–19 years of age) are in sub-Saharan Africa, where testing coverage remains low
Testing coverage is often low due to:
Age of consent laws
Structural barriers
Unfriendly services
Stigma and discrimination

10. Innovation Needed to Close the Testing Gap
So its clear there is a gap – we aren’t reaching those in need of testing services. So the question to us is what are we going to do. What approaches can be utilized as part of the HIV response to change the status quo and go further than we have before.
I think we can all agree we need to do more for key populations – but I am going to speak about one new innovation for testing that could potentially have a big impact for self-testing
Photo Credit:

11. Objectives of the new guidelines
Strengthen existing guidance
Strengthen existing guidance to promote couples and partner HTS, in particular offering voluntary HTS to the partners of all people diagnosed with HIV
Providing guidance on how HIVST and partner notification should be integrated into existing HTS approaches and tailored to specific population groups
Position HIVST and assisted partner notification as essential HTS approaches for closing the testing gap and achieving the UN’s 90–90–90 global goals
Support the routine offering of voluntary assisted HIV partner notification services as part of the public health approach to delivering HTS
Support introduction and scale-up of HIVST and assisted HIV partner notification in the most ethical, effective, acceptable and evidence-based manner
Support the implementation and scale-up
Source: WHO, 2016 ; Photo credits (top to bottom): Krista Dong, South Africa, PATH Viet Nam, Kim Green, WHO Europe

12. Overview of New HTS Guideline Supplement
Summary
Introduction
HIV self-testing (HIVST)
Systematic Review
Values and preferences (V&P)
Resource use (Costs and cost effectiveness)
Performance/Accuracy of HIV RDTs for HIVST
Implementation considerations
3. HIV partner notification (PN) services
V&P
Resource use (Costs and cost-effectiveness)
Methods for contacting partners
Additional Background work
Country policy analysis on HIVST and PN
Risk-benefit analysis on HIVST
Lit review on social harm in HTS
Cost-effectiveness of HIVST
Key informant interviews & focus discussion groups on HIVST and PN in several WHO Regions:
AFRO
AMRO
EMRO
WPRO/SEARO

13. New Recommendations
HIV self-testing should be offered as an additional approach to HIV testing services
(strong recommendation, moderate quality evidence)
Voluntary assisted partner notification services should be offered as part of a comprehensive package of testing and care offered to people with HIV
(strong recommendation, moderate quality evidence).

14. HIV Self-Testing

15. HIV Self-Testing (HIVST)
HIV self-testing a process in which a person collects his or her own specimen (oral fluid or blood) and then performs a test and interprets the result, often in a private setting, either alone or with someone he or she trusts. HIV self-testing does not provide a definitive diagnosis. All reactive test results need further testing by health provider according to a national validated algorithm.
Collects
Performs
Interprets
Reactive results need confirmation by trained tester using a validated national algorithm

16. WHO HIVST Strategy
HIVST requires self-testers with a reactive (positive) result to receive further testing from a trained provider using a validated national testing algorithm.
All self-testers with a non-reactive test result should retest if they might 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

17. HIVST Service Delivery
Strategic Planning
HIVST Service Delivery
There are many possible public and private sector HIVST approaches.
Programmes should evaluate their existing HIV testing approaches and determine where and how to implement HIVST so that it is complementary and addresses gaps in current coverage.

18. HIVST Policy Landscape
As of October 2016, 23 countries report having policies supportive of HIV self-testing
Despite the development of policies – implementation is limited to high-income countries and research projects, as well as the private sector and internet in many settings.
Source: WHO 2016 – Global Report; GARPR (WHO, UNAIDS, UNICEF)

19. Key Findings: Uptake & Frequency
Moderate quality evidence that HIVST doubled overall HIV testing uptake compared to standard HTS (effect also shown for couples testing)
Low quality evidence that HIVST resulted in 2 more tests in a month period compared to standard HTS
Moderate quality evidence that HIVST doubled the uptake of HIV testing compared to standard HTS (RR = 2·12; 95% CI: 1·51, 2·98; Tau2=0∙08; Chi2=32·88, df=2 (p=0∙001;I2=94%))
among MSM in Hong Kong SAR (with no test in past 6-months) than standard HTS who were:
Young MSM: RR=1·79; 95% CI: 1∙43, 2·24
MSM reporting CAI at baseline: RR = 1·75; 95% CI: 1·26,1·81
Recent testers (> 4 tests in 3 years): RR = 1·75; 95% CI: 1·46, 2·08
Non-recent testers (0-3 tests in 3 years): RR = 2·22; 95% CI: 1·61; 3·08)
Jamil et al also showed HIVST increased the frequency of testing among non-recent testers compared to standard HTS
Gichangi et al potentially caused by not including men who did not opt to test.

20. Potential Social Harm & Adverse Events
Studies report HIVST can be empowering
Social harm due to HIVST was not identified in RCTs –reports from other observational studies were limited and did not suggest HIVST increased risk of harm
In Malawi, two-years of implementing HIVST found no suicides, no self-harm and no cases of IPV.
In Kenya 4 cases of IPV identified but unclear if due to HIVST and 41% of participants reported IPV 12 months prior to intervention
Programmes need to provide clear messages to address potential harm
Monitoring & reporting system for HIVST are key
Tools such as hotlines/mobile phones, community-based monitoring systems, computer programmes, post-market surveillance systems, etc. can be utilized

21. Concordance of HIV RDT result performed by self-tester compared to trained health worker
Measured using kappa statistic – 16 studies

22. Sensitivity and Specificity
as high as 98.8% (95% CI 96.6 – 99.5%)
Specificity
as high as 100% (95% CI 99.9 – 100 %)
Sensitivity and specificity was higher for blood-based (n=4/16) vs. oral fluid (n=13/16) (sensitivity % compared vs %; specificity % compared vs %).
n = 18 studies
Figueroa et al Poster AIDS 2016, WEPEC207; HIVST.org

23. HIVST Acceptability and Willingness
Ranged from 21% to 100% (median: 82.9%)
Data among general populations, young people, couples, key populations and across WHO regions. AFR: African Region; AMR; American Region; EUR: European Region; SEAR: Southeast Asia Region; WPR: Western-Pacific Region
Source: WHO 2016 – see hivst.org for latest data on acceptability and willingness.

24. Summary of Values & Preferences
HIVST is highly acceptable among many different groups and across different settings – but some concern about potential lack of counselling and support, accuracy of test results, and related costs
Individuals surveyed about HIVST had concerns about possible harm, but most had not self-tested, and concerns were not founded in evidence –despite concern most still found HIVST acceptable
Many users prefer oral HIVST (e.g. painless) – but many studies did not inform respondents about performance.
Some studies show when participants are informed they may actually prefer fingerprick/whole blood-based HIVST.
Preferences across service delivery approaches vary
Key populations, in particular, reported preferences for pharmacies, the Internet, and over-the-counter approaches more appealing because they are more discreet and private

25. 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 applications
Unassisted 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

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

27. Key messages for users and implementers
Use of approved HIV RDT for self-testing, either by national or international authority
Use 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 reactive results need further testing, provide information on what to do after a reactive self-test result
Make sure pre-test information and post-test counselling messages are accessible and available to all self-testers – and that health workers and providers are trained to deliver these messages
Integrate HIVST into comprehensive sexual health service programmes and provide messages and information on tuberculosis, STIs and viral hepatitis.

28. Current HIVST Products Manufacturer Assay name
SENS
SPEC
Gen.
Specimen
Approval Status
Price Per Test (US$)
Autotest VIH
(AAZ Labs, France)
100%
99.8%
2nd
Blood CE
25-28
(to consumer)
INSTI HIV Self Test
(Bioanalytical, Canada)
3rd* 36
(to consumers)
Private Sector Version
Biosure HIV Self Test
(Biosure, UK)
99.7%
99.9%
38-43
(to consumer)  
Public Sector Version
7.50–15
(to public sector)
OraQuick In-Home HIV Test
(OraSure Technologies, USA)
Pending CE NA
91.7%
Oral
FDA 40
OraQuick In-Home HIV Self-Test
Available Upon Request
GF/ERPD
There are currently products with the equivalent of a stringent regulatory approval – but these products are costly at the moment.
There continues to be a growing informal market for HIVST which are lower cost and available many settings- and public demand is outpacing the public health response.
There are currently 5 produce (6 including a lower-cost packaging version of the same product) with stringent regulatory approval. There are another nine products in the pipeline for HIVST.
As we await the Global Fund ERPD process - it is urgent to work to have WHO PQed products which are low cost and quality assured.
Many other products are underdevelopment & in the pipeline
New
*With approval from a founding member of the GHTF, All information is provided by manufacturers (UNITAID/WHO Landscape July 2016) – Personal Communication from UNITAID and Global Fund Nov 2016

29. WHO PQ: HIV RDT for self-testing
WHO PQ is actively accepting applications for HIV RDTs for self-testing
2 HIVST products currently under review
Technical Specifications for HIVST is being finalized – will be available end

30. Assisted HIV Partner Notification

31. What is Partner Notification?
Partner notification, or disclosure, or contact tracing, is a voluntary process whereby a trained provider asks people diagnosed with HIV about their sexual partners and/or drug injecting partners and then, if the HIV-positive client agrees, offers these partners HTS.

32. Partner notification is provided using assisted or passive approaches
Passive HIV partner notification services refer to when HIV-positive clients are encouraged by a trained provider to disclose their status to their sexual and/ or drug injecting partners by themselves, and to also suggest HTS to the partner(s) given their potential exposure to HIV infection.
Assisted HIV partner notification services refer to when consenting HIV-positive clients are assisted by a trained provider to disclose their status or to anonymously notify their sexual and/or drug injecting partner(s) of their potential exposure to HIV infection. The provider then offers HIV testing to these partner(s). Assisted partner notification is done using contract referral, provider referral or dual referral approaches.

33. Types of Assisted Partner Notification
Contract referral: HIV-positive clients enter into a “contract” with a trained provider and agree to disclose their status and the potential HIV exposure to their partner(s) by themselves and to refer their partner(s) to HTS within a specific time period. If the partner(s) of the HIV-positive individual does not access HTS or contact the health provider within that period, then the provider will contact the partner(s) directly and offer voluntary HTS.
Provider referral: With the consent of the HIV-positive client, a trained provider confidentially contacts the person’s partner(s) directly and offers the partner(s) voluntary HTS.
Dual referral: A trained provider accompanies and provides support to HIV-positive clients when they disclose their status and the potential exposure to HIV infection to their partner(s). The provider also offers voluntary HTS to the partner(s).

34. Why is Assisted Partner Notification (PN) Important for HIV?
Assisted PN has been used in infectious disease management to identify others who have been exposed to infections & to enable treatment
Including for STIs, TB
Infrequently used for HIV
Sexual and drug injecting partners of people with HIV have increased probability of also being HIV-positive
Without PN these partners are unaware of their exposure
Continued HIV transmission to partners and infants if they remain undiagnosed
Difficulty in controlling the epidemic

35. Scientific Evidence on PN
WHO systematic review of the evidence from 4 RCTs showed that assisted HIV partner notification can:
Increase uptake of HIV testing services among partners of people with HIV
Result in high proportions of HIV-positive people being newly diagnosed
Result in increased linkage to treatment and care among partners of people with HIV
Few cases of harm resulted from PN in studies & programmes
Fears of harm following PN have been raised, however these concerns have not been borne out in RCTs and programmes implementing PN thus far
Potential for harm should be discussed with HIV-positive clients before PN
For full details in WHO guidelines see:

36. Timing of Assisted PN May Be Important
2 randomized controlled trials (RCT) in Malawi showed that the difference in notification rates between passive- and assisted partner notification became more pronounced over time
Another RCT showed improved HTS uptake with immediate PN compared to delayed PN
Source: Brown et al., JAIDS. 2011;56(5):
Source: Rosenberg et al. Lancet HIV. 2015;2(11):e483-e91.

37. Benefits of PN Benefits to couples/partners:
Mutual support to access HIV prevention, treatment and care services
Improved adherence and retention on treatment
Increased support for the prevention of mother-to-child transmission
Prioritization of effective HIV prevention for serodiscordant couples
Condoms
Antiretroviral therapy
Pre-exposure prophylaxis for HIV-negative partners

38. Example of assisted PN of a young woman who engaged in transactional sex
LVCT Health is a non-governmental organization in Kenya that delivers HIV testing services (HTS), prevention interventions, and care and treatment to the general population, key populations, and adolescents in community and facility settings.
The program is funded by the Presidents Emergency Plan for AIDS Relief through the U.S. Centers for Disease Control and Prevention through a cooperative agreement. A pilot partner notification programme was conducted in two informal settlements of Mlolongo and Kawangware in Nairobi from December 2015 to May Lay counsellors offering HTS in community settings (HTS sites, outreach, and door-to-door) used contract referral to identify the sexual partners and family members of HIV-positive clients, as well as social contacts among key populations who could benefit from HTS.
Lay counsellors received training on partner notification, screening for intimate partner violence (IPV) and creating a confidential and safe environment for HIV-positive clients to identify the sexual partners whom they wished to notify. The counsellors used a register to record phone numbers and the physical location of identified partners. Counsellors notified partners face-to-face and encouraged them to test for HIV. Counsellors made appointments for clinic or home visits for partner testing, including with their family members if requested. Results of partners identified, notified, and tested were reviewed on a weekly basis with monthly supervision of counsellors.
Of 341 clients who tested HIV-positive, 205 participated in the programme. The 205 HIV-positive clients identified 580 partners/contacts, of whom 331 (57%) returned for HIV testing; 116 (35%) were found to be HIV positive. Among the HIV-positive partners/contacts, 104 (90%) were adults, while 12 (10%) were children. A total of 91% of the HIV-positive contacts were enrolled in HIV care. No social harm was reported.

39. New Recommendations
Voluntary assisted partner notification services should be offered as part of a comprehensive package of testing and care offered to people with HIV
(strong recommendation, moderate quality evidence).

40. Potential challenges with PN
Identification of partners
Some people and groups such as key populations may be reluctant to name partners
Depends on relationship dynamics
Locating and notifying partners
Locating partners may be difficult, particularly for non-primary/casual partners and for mobile, vulnerable or key populations
Laws or policies that stigmatize, criminalize or discriminate against key populations or people with HIV

41. Important Considerations for Implementing PN
Confidentiality and voluntariness are critical
PN should always be voluntary
Notification should be made to partner(s) alone, and to nobody else.
Criminal justice/law enforcement/non-health personnel should not be involved in PN
HIV-positive clients should be given options for PN and be allowed to choose different PN methods for different partners
PN should be offered periodically
Peoples’ situations change
Readiness to consent to PN and/or disclose to partners may change

42. Potential Contact Methods for PN
Preferences for PN method differ by population, age and partner type (primary or non-primary).
Assisted PN methods could include
Face-to-face conversations with partners
Phone calls
Text messages s
Videos and Internet-based messaging systems
Care is needed when using phone calls and text messaging to ensure that the correct person receives the message and that the anonymity of both the HIV-positive client and notified partner is maintained.

43. Monitoring PN
All documentation, monitoring and reporting systems must ensure the security and confidentiality of HTS client data as well as the personal and medical information of partners.
PN documentation could include:
Number of HIV-positive persons who are offered assisted partner notification services
Number of HIV-positive persons who accept assisted partner notification services
Number of partners identified per HIV-positive client
Number of partners who were notified (+ number of notification attempts)
Number of partners who accept HTS, and their HIV status
Number of HIV-positive partners enrolled in care and treatment
Number and type of adverse events occurring to HIV-positive clients following partner notification

44. World Health Organization
Acknowledgements
Rachel Baggaley, Cheryl Johnson, Carmen Figueroa, Shona Dalal, Caitlin Kennedy, Virginia Fonner, Nandi Siegfried, Anita Sands, Robyn Meurant, Caitlin Payne, Nathan Ford, Michel Beusenberg, Theresa Babovic, Daniel Low-Beer, and Keith Sabin Special thanks to everyone who assisted with developing this recommendation: Steering Committee, Guideline Development Group, HIVST Technical Working Group, 75+ peer reviewers, all contributors of case examples, editors, designers, administrative, communications and technical support teams. Funding of the guidelines provided by UNITAID and Bill, Melinda Gates Foundation and the United States Agency for International Development and the President’s Emergency Plan for AIDS Relief.