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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