Debate topicHIV Self-testing should be

implemented for all adolescents

Gabriel Chamie, MD, MPHAssociate Professor of Medicine

Division of HIV, Infectious Diseases & Global MedicineUniversity of California, San Francisco (UCSF)

• The need for widespread, easily accessible HIV testing for adolescents is clear– Adolescents (15-24 years) represented 42% of new

HIV infections in people >15 in 20101

– In the US, 59% of 13-29 year olds remain undx’d2

– In Sub-Saharan Africa, only 1 in 5 adolescent girls know their HIV status2

• But… is HIVST the solution for diagnosing alladolescents? Nope!

HIV Self-Testing (HIVST)

1UNAIDS, 2012 2Wong, AIDS, 2017

HIVST: An exciting testing modality

Health Facility/Clinic-based

Testing

Out-of-facility/Community-

Based Testing

Out-of-health care/Unsupervised

Self-Testing

Risk/Benefits of moving to HIVST for All

• Before deciding ONE testing modality is right fit for all, let’s consider the tradeoffs involved

Benefits

• Autonomy• Privacy/Anonymity• Avoids health

center/clinic interaction

• Acceptable/”easy”• Partner testing

Risks and Unintended consequences

?

Adolescents at high risk of NOT linking to care/starting ART after HIV+ diagnosis

• Linkage rates are lower• Lower retention and viral suppression

Risk #1: Lower Linkage to Care & Rx

6% vs 30% in adults

Zanoni, AIDS Pt Care & STDs, 2014. Gardner, CID, 2011

Risk #1: Lower Linkage to Care & Rx

Probability of 1 year retention in care if newly HIV+ lower in 15-24 year olds than >25 in the SEARCH trial in Kenya &Uganda

Brown, AIDS, 2016

25-29

≥30

What do we know about linkage after HIVST?... Little!– After 2 years of promoting HIVST in Malawi1

• 76% of self-testers shared their results• 42% of HIV+ linked to care

– Little/No data on linkage after HIVST in adolescents

Risk #1: Lower Linkage to Care & Rx

1Choko, PlosMed, 2015

• Important to study linkage/treatment after HIVST further before recommending HIVST for all adolescents

• Adolescents need more support when testing, not less, especially if newly HIV+

Take Away Points

• Sexual/reproductive health education lacking for adolescents in many settings

– In population-based surveys, 24% of young women and 36% of young men responded correctly to 5 questions on HIV prevention & transmission (UNAIDS, 2012)

Risk #2: Unsupervised Testing = Missed Opportunity for Health/Prevention Education

Idele et al, JAIDS, 2014

50% 50%

• HIV is not the only health-related issue for adolescents!

– Sexual debut/Pregnancy/STIs/education/Prevention

– Depression/anxiety– May not realize they are at risk!

Risk #2: Unsupervised Testing = Missed Opportunity for Health/Prevention Education

Take Away Points

• HIVST does not address low health literacy!

• Unsupervised = Missed Opportunity

Most initial data suggest HIVST are easy to use, but...

Assessment of user understanding of packaged “Instructions-for-use” among 20 literate adults given OraQuick with no other assistance:

Risk #3: User Error

Indravudh et al, CROI 2017

35% could not even open the package!

Impact on sensitivity?• RCT of unsupervised vs. provider-supervised

HIVST (oral tests) in 246 adults in Uganda– Unsupervised:10% drop in sensitivity (90% vs. 100%)

in ITT analysis– Non-inferiority was not shown

• Unsupervised: 24% needed some form of additional help• Supervised: 42% requested additional help

Risk #3: User Error

Asiimwe, AIDS Behav, 2014

Even the former US President was apparently unable to HIVST without assistance!

Risk #3: User Error

Take Away Point

False Negative Results = False Reassurance• The Window Period & Serosorting

– 4-12 week window period between HIV infection & antibody detection with rapid tests (e.g. Oraquick)1

• Can miss acute/early infections– 42% of global incident HIV in young (15-24) people2

• Young people may lack data on the window period3

– Serosorting/Condomless sex after negative HIV self-test has been reported in HIVST trials

• 56% reported condomless sex after negative HIVST in RCT in Kenyan women4

Risk #4: Window Period

1WHO HIVST Guidelines, 2016; 2UNAIDS, 2012; 3Brown, AIDS Behav, 2016; 4Thirumurthy, Lancet HIV, 2016

• “Serosorting following HIVST is not recommended in population groups with high HIV incidence.”1

Risk #4: Window Period

• Adolescents are a high HIV incidence group• False negative results in window period +

condomless “serosorting” = not good

Take Away Points

1WHO HIVST Guidelines, 2016

Risk #5: Coercion/IPV

• True, the data are so far reassuring for adults, as well as adolescents in Malawi1

• Do we have enough data in adolescents to know that this is likely to remain a rare outcome in all settings?

1Choko, PlosMed, 2015

Benefit #1: If HIV+• Can facilitate linkage and prompt treatment

– Prompt ART start can be life-saving – Decreased time from testing to treatment may

increase retention in care1

• Provide counseling/support post-diagnosis

Benefits of HIV testing with a provider

1Philbin, JAIDS, 2016

Benefit #2: If HIV-• Can provide

combination biomedical prevention interventions

Benefits of HIV testing with a Provider

Imagine the vending machine required for combination prevention…

Benefit #3: Reaching coverage goals: High rates of HIV testing areachievable and measurable with community health approaches

Benefits of HIV testing with a provider

Kadede, AIDS, 2016

90%

It’s not just about HIV

Summary

• Always tempting to think of a new, innovative technology as the solution, but…

• Many risks, especially unsupervised:1. Linkage/Retention/ART after HIVST2. Missed Opportunities for Health Education/Prevention3. User Error4. Window Period & Serosorting; False reassurance5. Coercion/IPV

• Many benefits with other community-based HTC approaches!

• Avoid “one size fits all” thinking!

• HIV Self-testing is an answer to some testing challenges, but not all!– Access

• Need for removal of testing barriers (e.g. parental permission) regardless of testing modality

Rebuttal

– Anonymity?/Decreased stigma?• Perhaps not, if you have to pick up self-tests from a

health care setting/community outlet

Rebuttal

Can I get a price check on this 12-pack of HIV Self-Tests? @#$%!!!

• Low rates of user error are from high quality RCTs... – Need more data on real-world settings & real-

world use among adolescents before recommending HIVST for all:

• “Both accuracy and uptake of services post-testing will need revaluation if different test kits or less supportive models are considered, for example, over-the-counter or vending machine sales.” -Choko, PLoS Med, 2015

Rebuttal

• To quote a respected authority on HIVST:– “HIVST may not be an appropriate or safe

approach for all populations. It is important that information on where and how to access other HTS approaches, including community-based options, continues to be provided.”

- Cheryl Johnson, JIAS, 2017

Rebuttal

Key Take Away Point

Vote “NO” on the proposal that HIV Self-Testing should be implemented for ALL adolescents!!!