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

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, New WHO recommendations:

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)

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)

What is HIV self-testing (HIVST)? Positive results need confirmation Source: WHO March 2014 supplement to ARV Guidelines

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

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 ]

Estimating the annual cost of retesting Estimates based on 100 clients in 1 st 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

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.

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.

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

Annual Cost per Person as Cost of HIVST Kit Changes HIVST kits in Kenya cost ~10USD HIVST kits cost ~3USD in Malawi

Annual HIV re-testing cost with PrEP implementation in Kenya per person $3 per HIVST Kit

Sensitivity Analysis for Annual Re-Testing Cost per Person Supervised HIVST Cost 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 $ $ 43 $48 $53 $58 $ 63 $68 $72 $77 $82. $87 20 $ 49 $54 $59 $63 $ 68 $73 $78 $83 $88 $ $ 54 $59 $64 $ 69 $ 74 $79 $84 $89 $94 $ $ 60 $65 $70 $ 75 $ 80 $85 $89 $94 $99 $ 104 Green = Least expensive of three options Orange = Less expensive than facility-based testing White = Facility-Based is least expensive

Sensitivity Analysis for Annual Re-Testing Cost per Person Unsupervised HIVST Cost of HIVST Kit HW time per facility visit (min) $1$2$3$4$5$6$7$8$9$10 10 $ 31 $34 $36 $39 $42 $45 $48$51 54 $ $ 41 $44 $47 $50 $53 $56 $59 62$65 $ $ 52 $55 $58 $61 $64 $67 $70$73$76 $ $ 63 $66 $69 $72 $75 $77 $80$83$86 $ $ 74 $76 $79 $82 $85 $88 $91 94$97 $100 Green = Least expensive of three options Orange = Less expensive than facility-based testing White = Facility-Based is least expensive

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

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

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 1 st 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?

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.

Acknowledgements Kathryn Curran, Kenneth Ngure, Rachel Baggaley, Jared Baeten, Nelly Mugo, Renee Heffron, Kevin O’Reilly, and Florence Koechlin

Standard WHO Serial Algorithm Low prevalence ( < 5%) High prevalence ( < 5%)

Option 1: Facility-based re-testing Facility HTC every 3 months Diagnosis, stop PrEPContinue PrEP DeterminePositive Elisa Unigold Negative PositiveNegative National Testing Algorithm

Option 2: Facility-based Supervised HIVST HIVST Training Facility-based HIVST re-testing every 3 months PositiveNegative Serial Algorithm: Determine & Unigold (see option 1) Continue PrEP

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