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The potential role of HIV self-testing within
pre-exposure prophylaxis implementation
Cheryl Case Johnson
World Health Organization, HIV Department
Geneva, Switzerland
Abstract Number: TUAC0101
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Pre-exposure prophylaxis (PrEP)
– Strong recommendation for MSM *
– Conditional recommendation for other populations**
– Prevention strategy for serodiscordant couples (SDCs)**
• Daily oral ARVs for HIV negative persons to prevent acquisition
*WHO Consolidated KP Guidelines, 2014; **WHO Guidelines for PrEP Demonstration Projects, 2012.
• New WHO recommendations:
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PrEP demonstrations underway, but questions remain:
• Who should take PrEP?
• How should it be delivered?
• How much does it cost & how can costs be reduced?
Pre-exposure prophylaxis (PrEP)
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Cost of Re-Testing• Recommended every 3 months (CDC)
for HIV negative individuals on PrEP
• Can burden health workers & facilities
• Can burden patients
Risk of Not Re-Testing• Potential seroconversion and drug-
resistant virus
Pre-exposure prophylaxis (PrEP)
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What is HIV self-testing (HIVST)?
Positive results need confirmation
Source: WHO March 2014 supplement to ARV Guidelines
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Many possible HIVST models*
• Potential models with varying levels of support, access and distribution or initiation
• Examined 2 facility-based models:• Supervised facility-based HIV self-testing • Unsupervised HIV self-testing alternated
with facility-based testing
Source: WHO March 2014 supplement to ARV Guidelines
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Partner’s Demonstration Project: Thika, Kenya
Open-label PrEP for SDC study data used for preliminary costing exercise*
HIVST sub-study: – Between quarterly clinic visits
for PrEP prescriptions & HIV testing
– HIVST training & distribution of kits for home use
– Examining HIVST uptake, preferences etc.
*Ngure, K et al. Uptake of HIV Self-testing among people receiving PrEP in Kenya R4P, 2014 [A-671-0020-00477]
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Estimating the annual cost of retesting
Estimates based on 100 clients in 1st year of PrEP programme:
• Commodities (rapid test kits, supplies),
• Human resources:• 30 minutes counselling per facility test, • 30 minutes for initial HIVST training, • 10 minutes for subsequent HIVST • Support 24-hour telephone hotline
• 98% enrollment into HIVST • Serial Algorithm: Determine & Unigold
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Option 1. Facility-based HIV testing
Option 1: Standard facility-based testing algorithm using Determine, Unigold and ELISA test (no HIV self-testing). • In this model HIV negative users on PrEP re-test
for HIV in a facility every 3 months.
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Option 2. Supervised HIVST in a facility
Facility-based supervised HIV self-testing where users self-test in a private place within a facility every 3 months.
• Less counselling, health worker simply provides support as needed.
• Individuals with a reactive (positive) self-test result re-test as detailed in Option 1.
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Option 3: Unsupervised HIVST & facility-based HIV testing
Alternating between quarterly (every 3 months) in-clinic facility-based test and at-home self-test.
• Reactive (positive) self-tests re-test in a facility (see Option 1).
• In one year: client visits facility every 6 months
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Annual Cost per Person as Cost of HIVST Kit Changes
$1 $2 $3 $4 $5 $6 $7 $8 $9 $10 $50
$60
$70
$80
$90
$100
$110
Facility-Based
Supervised HIVST
Unsupervised HIVST
Cost of HIVST Kit
Cos
t per
Per
son
HIVST kits in Kenya cost ~10USD
HIVST kits cost ~3USD in Malawi
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Annual HIV re-testing cost with PrEP implementation in Kenya per person $3 per HIVST Kit
Facility-Based Supervised HIVST Unsupervised HIVST
$-
$10
$20
$30
$40
$50
$60
$70
$80
$90
$78
$54 $64
$5
$15 $9
Hotline
Facility Commodities Cost
HIVST Com-modities Cost
Salary CostCos
t per
Per
son
(USD
)
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Sensitivity Analysis for Annual Re-Testing Cost per Person
Supervised HIVSTCost of HIVST Kit
HW
time
per facility
visit
(min)
$1 $2 $3 $4 $5 $6 $7 $8 $9 $10
10 $ 37 $42 $47 $52 $ 57 $62 $67 $72 $77 $ 81.
15 $ 43 $48 $53 $58 $ 63 $68 $72 $77 $82. $87
20 $ 49 $54 $59 $63 $ 68 $73 $78 $83 $88 $ 93
25 $ 54 $59 $64 $ 69 $ 74 $79 $84 $89 $94 $ 99
30 $ 60 $65 $70 $ 75 $ 80 $85 $89 $94 $99 $ 104
Green = Least expensive of three optionsOrange = Less expensive than facility-based testingWhite = Facility-Based is least expensive
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Sensitivity Analysis for Annual Re-Testing Cost per Person
Unsupervised HIVSTCost of HIVST Kit
HW
time
per facility visi
t (min)
$1 $2 $3 $4 $5 $6 $7 $8 $9 $10
10 $ 31 $34 $36 $39 $42 $45 $48 $51 54 $ 57
15 $ 41 $44 $47 $50 $53 $56 $59 62 $65 $ 68
20 $ 52 $55 $58 $61 $64 $67 $70 $73 $76 $ 79
25 $ 63 $66 $69 $72 $75 $77 $80 $83 $86 $ 89
30 $ 74 $76 $79 $82 $85 $88 $91 94 $97 $100
Green = Least expensive of three optionsOrange = Less expensive than facility-based testingWhite = Facility-Based is least expensive
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Key Findings• Re-testing with HIVST could be less costly than
current facility-based re-testing
• Annual re-testing with HIVST costs less than facility-based re-testing when:
– HIVST kit is ≤5USD (supervised HIVST)
– HIVST kit is ≤3USD (unsupervised HIVST)
• Other re-testing scenarios using HIVST may also lead to cost-savings
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Key Findings• HIVST kits are expensive, but health worker time is
more expensive.
– Decreasing the amount of health worker time & cost of test kits can significantly reduce costs per person
– Sensitivity analysis shows many scenarios where HIVST (supervised & unsupervised) can be less expensive
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Limitations• Preliminary costing exercise
• Only factored in re-testing cost, not additional services
– Did not factor in opportunity cost, public health benefit, other potential risks & benefits of re-testing with HIVST
– Other scenarios of HIVST are possible
– Only examined 1st year of re-testing costs
• Questions remain about who and how many will be eligible for re-testing using HIVST
– Who is most likely to benefit and how will providers identify who is eligible?
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Conclusion & Next Steps• Introducing supervised or unsupervised HIVST could:
– Reduce number of facility visits
– More private, convenient way to re-test
– Reduce re-testing costs
• HIVST kit cost ≤3USD to significantly reduce re-testing costs.
• Research is needed to explore the cost-effectiveness of introducing HIVST within PrEP programmes– Analyses factoring opportunity costs, public health impact,
and other potential risks and benefits.
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AcknowledgementsKathryn Curran, Kenneth Ngure, Rachel Baggaley, Jared Baeten, Nelly Mugo, Renee Heffron, Kevin O’Reilly, and Florence Koechlin
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Standard WHO Serial Algorithm Low prevalence ( < 5%) High prevalence ( < 5%)
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Option 1: Facility-based re-testing
Facility HTC every 3 months
Diagnosis, stop PrEPContinue PrEP
Determine Positive Positive ElisaUnigold
Negative Negative PositiveNegative
National Testing Algorithm
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Option 2: Facility-basedSupervised HIVST
HIVST Training
Facility-based HIVST re-testing every 3 months
PositiveNegative
Serial Algorithm: Determine & Unigold
(see option 1)
Continue PrEP
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Option 3: Facility-based Unsupervised HIVST
HIVST Training
Facility HTC re-testing every 3 months
PositiveNegative
Diagnosis, stop PrEP
Continue PrEP
HIVST retest 3 months
Facility HTC: Serial Algorithm: Determine & Unigold (option 1)
Home HIVST re-testing every 3 months
NegativePositive
Continue PrEP
facility HTC retest 3 months
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