HP+/Project SOAR Oral PrEP Modeling. Webinar Series: Five Ways to Accelerate Progress Toward the Goals January 16, 2018

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HP+/Project SOAR Oral PrEP Modeling Webinar Series: Five Ways to Accelerate Progress Toward the 95-95-95 Goals January 16, 2018

Activity Overview 2

Activity Objective Provide impact, cost, and cost-effectiveness data for decision-making to assist countries in strategic planning for the introduction and scale-up of oral pre-exposure prophylaxis (PrEP) 3

Activity Process July- December 2017 August- October 2017 November- December 2017 December 2017- January 2018 Identify specific modeling questions related to oral PrEP introduction (Mozambique, Lesotho, Uganda, Swaziland) Develop modeling approach and adapt tools/create new tools Distill lessons to design a desk analysis that can be applied to additional countries Provide data for decision-making to facilitate introduction or scale-up of oral PrEP

Activity Countries In-depth country exercises conducted in Swaziland, Uganda, Mozambique, and Lesotho Different stages for PrEP introduction and roll-out Country buy-in and interest Desk studies in: Ethiopia Haiti Kenya Malawi Nigeria Tanzania Zambia Zimbabwe 5

Activity Methodology Expand and adapt existing modeling tools Incidence Patterns Model (IPM): uses published data in DHS and AIS surveys to estimate HIV incidence in each risk group and province o Used to estimate correction factors for HIV incidence in Goals, allowing projections for populations not included as part of the Goals model structure (sero-discordant couples, specific age groups) Goals model o Apply correction factors estimated from IPM analysis to disaggregate HIV incidence in Goals risk groups to account for additional population groups Combine these tools into a single platform that is designed to address policy questions raised in country Oral PrEP Workbook is a Microsoft Excel-based tool that links the IPM with Goals and visualizes the results 6

Oral PrEP Modeling Questions Q1. How would different scenarios for rolling out oral PrEP to progressively broader sub-populations based on risk and geography affect the impact, cost-effectiveness, and total cost of the program? Q2. How do the impact, cost, and cost-effectiveness vary by risk group? o o o o o o Female sex workers (FSW) Sero-discordant couples (SDCs) Men who have sex with men (MSM) People who inject drugs (PWID) Adolescent girls and young women with multiple partners (AGYW) Adult men (AM) Q3. How would varying levels of future scale-up of ART and VMMC affect the impact and cost-effectiveness of oral PrEP? Q4. How would varying unit cost of oral PrEP by risk group affect the relative cost-effectiveness of providing PrEP to the different risk groups? Q5. How would varying levels of adherence by risk group affect the relative impact and cost-effectiveness of providing PrEP to the different risk groups? 7

Results Uganda Example 8

How would rolling out oral PrEP to different risk groups and geographic areas affect the impact, costeffectiveness, and total cost of oral PrEP?

Example Oral PrEP Rollout Scenarios Female sex workers (FSW) and sero-discordant couples (SDC): National oral PrEP rollout FSW and SDC + geographically targeted young women: Same as above plus oral PrEP rollout for medium-risk adolescent girls and young women (multiple partners, not formal FSW) ages 15 24 in provinces/regions with higher than the median HIV incidence All risk groups: National oral PrEP rollout for FSW, SDC, and medium-risk adolescent girls and young women ages 15 24 Note: Unless otherwise indicated, the analyses on the following slides assume that the country achieves 90-90-90 targets by 2020 81% of PLHIV on ART, 90% of ART patients are virally suppressed, and 90% of males 10 29 are circumcised. 10

Scale-Up Pattern for Each Rollout Scenario Person-Years of PrEP by PrEP Rollout Scenario, 2018-2030 Person-Years of PrEP (Thousands) 1,000 900 5% coverage by 2020 40% coverage by 2025 800 700 50% coverage by 2030 600 500 400 300 200 100 0 2018 2020 2022 2024 2026 2028 2030 FSW/SDC FSW/SDC + Geog. Targeted AGYW FSW/SDC + AGYW Coverage: percentage of indicated target population provided with oral PrEP in indicated year 11

Impact from Rolling Out Oral PrEP 35,000 New HIV Infections Averted by PrEP Rollout Scenario, 2018-2030 30,000 25,000 20,000 15,000 10,000 5,000 0 FSW/SDC FSW/SDC + Geog. Targeted AGYW FSW/SDC + AGYW -ART scenario: 90-90-90 by 2020 12

Unit Cost Derivation: Annual cost of oral PrEP per person per year Kenya Average (USD) Uganda Average (USD) Uganda Average (UGX) Cost Category Target Target Target Other* $17 $17 UGX 59,845 Training $1 $1 UGX 3,591 Adherence $55 $32 UGX 114,137 Demand Generation $3 $2 UGX 5,568 Labs $17 $17 UGX 61,041 Personnel $26 $15 UGX 53,589 ARV $84 $50 UGX 179,210 Total Cost $202 $133 UGX 476,980 GNI PPP: UGANDA to Kenya 0.581469649 USD to UGX 3590.67 GNI PPP: Gross National Income Per Capita, a measure of each country s average labor costs.

The cost of adding oral PrEP to the HIV program depends on the size of the target population $800 Total Cost of PrEP Program (USD millions), 2018-2030 $700 $600 $500 $400 $300 $200 $100 $0 FSW/SDC FSW/SDC + Geog. Targeted AGYW FSW/SDC + AGYW -ART scenario: 90-90-90 by 2020 14

Cost-Effectiveness of Rolling Out Oral PrEP $25,000 Cost per HIV Infection Averted, 2018-2030 $20,000 $15,000 $10,000 $5,000 $0 FSW/SDC -ART scenario: 90-90-90 by 2020 FSW/SDC + Geog. Targeted AGYW FSW/SDC + AGYW 15

Geographically prioritizing oral PrEP for young women in Uganda increases cost-effectiveness without sacrificing impact Number of HIV Infections Averted 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 Cost-Effectiveness, HIV Infections Averted, and Total Cost by PrEP Rollout Scenario, 2018-2030 $288M $448M $753M 0 $0 $5,000 $10,000 $15,000 $20,000 $25,000 $30,000 Cost per infection averted FSW/SDC FSW/SDC + Geog. Targeted AGYW FSW/SDC + AGYW -Bubble size and data labels: Total cost of adding PrEP program, USD millions -ART scenario: 90-90-90 by 2020 16

Efficacy trial Country or city Annual HIV incidence in control group (95% CI) ASPIRE (MTN 020) Incidence South Africa in control groups 6.2% (4.7%, 7.9%) ASPIRE (MTN 020) Malawi, Uganda, Zimbabwe 2.6% (1.7%, 3.9%) Ring Study (IPM 027) South Africa and Uganda 6.1% (4.6%, 7.9%) FACTS 001 South Africa 4.0% (3.1%, 5.2%) MTN 003 (Voice) South Africa, Uganda, Zimbabwe 4.2% (2.9%, 5.8%) MTN 003 (Voice) South Africa, Uganda, Zimbabwe 6.8% (5.3%, 8.6%) FEM-PrEP Arusha (Tanzania) 0.0% (NA) FEM-PrEP Bloemfontein (South Africa) 3.4% (0.9%, 8.7%) FEM-PrEP Bondo (Kenya) 4.7% (2.6%, 7.9%) FEM-PrEP Pretoria (South Africa) 6.0% (3.5%, 9.6%) HPTN 043 South Africa, Tanzania, Zimbabwe 2.4% (CI NA) HPTN 035 United States, Malawi, South Africa, Zambia, Zimbabwe 3.9% (2.9%, 5.1%) HPTN 035 United States, Malawi, South Africa, Zambia, Zimbabwe 4.0% (3.0%, 5.3%) HVTN 503 (Phambili) South Africa 7.4% (2.4%, 17.4%) RV144 (Thai Trial) Thailand 0.3% (0.2%, 0.4%) CAPRISA 004 South Africa 9.1% (6.9%, 11.7%) MDP 301 South Africa, Tanzania, Uganda, Zambia 4.2% (3.4%, 5.3%) HPTN 039 South Africa, Zimbabwe, Zambia 3.1% (2.1%, 4.5%) MIRA Harare (Zimbabwe) 2.5% (1.9%, 3.3%) MIRA Durban (South Africa) 7.0% (5.5%, 8.8%) MIRA Johannesburg (South Africa) 3.3% (2.1%, 4.9%) Trials whose population was listed as Women, from HIV Incidence in Prevention Trials and Observational Studies: A Summary Table, downloaded June 15, 2017 from http://www.vaccineenterprise.org/timely-topics/hiv-incidence-summary-table 17

How do the impact, cost, and costeffectiveness vary by risk group?

Uganda Number of HIV Infections Averted 25,000 20,000 $30M 15,000 10,000 5,000 0 Cost-Effectiveness, HIV Infections Averted, and Total Cost of PrEP Program by Risk Group, 2018-2030 $123M $3M $1M $160M $465M $0 $20,000 $40,000 $60,000 $80,000 $100,000 Cost per HIV Infection Averted (USD) FSW PWID SDC MSM Geog. Targeted AGYW AGYW -Bubble size and data labels: Total cost of adding PrEP program, USD millions 19

Mozambique Cost-Effectiveness, HIV Infections Averted, and Total Cost of PrEP Program by Risk Group, 2018-2030 Number of HIV Infections Averted 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 $182M $129M $96M $47M $548M $0 $10,000 $20,000 $30,000 $40,000 $50,000 Cost per HIV Infection Averted (USD) FSW SDC MSM Geog. Targeted AGYW AGYW -Bubble size and data labels: Total cost of adding PrEP program, USD millions 20

Swaziland Cost-Effectiveness, HIV Infections Averted, and Total Cost of PrEP Program by Risk Group, 2018-2030 Number of HIV Infections Averted 1,600 1,400 1,200 1,000 800 600 400 200 0 $32M $3M $12M $2M $5M $0 $20,000 $40,000 $60,000 $80,000 $100,000 Cost per HIV Infection Averted (USD) FSW SDC MSM Geog. Targeted AGYW AGYW -Bubble size and data labels: Total cost of adding PrEP program, USD millions 21

Lesotho Cost-Effectiveness, HIV Infections Averted, and Total Cost of PrEP Program by Risk Group, 2018-2030 Number of HIV Infections Averted 1,000 900 800 700 600 500 400 300 200 100 0 $7M $2M $37M $5M $11M $0 $20,000 $40,000 $60,000 $80,000 Cost per HIV Infection Averted (USD) FSW SDC MSM Geog. Targeted AGYW AGYW -Bubble size and data labels: Total cost of adding PrEP program, USD millions 22

How would varying levels of future scaleup of ART and VMMC affect the impact and cost-effectiveness of oral PrEP?

Example ART and VMMC Scenarios 90-90-90 by 2020: Country achieves 90-90-90 targets by 2020 81% of PLHIV on ART, 90% of ART patients are virally suppressed, and 90% of males 10 29 are circumcised 90-90-90 by 2030: Country achieves 90-90-90 ART and VMMC targets by 2030 Continue Current Coverage: ART, VMMC, and viral suppression coverages remain at current levels 24

Oral PrEP has impact even with achievement of 90-90- 90; PrEP impact and cost-effectiveness increase as ART scale-up lags HIV Infections Averted 60,000 50,000 40,000 30,000 20,000 10,000 Cost-Effectiveness and Impact of PrEP Program by HIV Scale- Up Scenario, 2018-2030 0 $0 $5,000 $10,000 $15,000 $20,000 Cost per HIV Infection Averted (USD) 90-90-90 by 2020 90-90-90 by 2030 No Scale-up -PrEP Rollout: FSW/SDC + Geog. Targeted AGYW 25

PrEP prevents new HIV infections even with scale-up of ART and VMMC 500,000 450,000 400,000 350,000 300,000 250,000 200,000 150,000 100,000 50,000 0 Additional Infections Averted with Scale-Up of HIV Program and PrEP from 2018-2030 90-90-90 by 2030 90-90-90 by 2020 HIV Prevention Portfolio FSW/SDC + Geog. Targeted AGYW FSW/SDC FSW/SDC + AGYW 26

Questions? Brief break before finishing presentation more discussion to follow 27

How would varying unit cost of oral PrEP by risk group affect the relative costeffectiveness of providing PrEP to the different risk groups?

Unit Cost Derivation: Mozambique GNI PPP: Moz to Kenya Kenya Average (USD) Mozambique Average (USD) Mozambique Average (MZN) 0.380191693 USD to MZN 60.7249 Cost Category Target Target Target Other* $28 $28 MZN 1,721 Training $8 $8 MZN 506 Adherence $55 $21 MZN 1,262 Demand Generation $21 $8 MZN 493 Labs $17 $17 MZN 1,032 Personnel $44 $17 MZN 1,016 ARV $84 $84 MZN 5,101 Total Cost $257 $183 MZN 11,130 GNI PPP: Gross National Income Per Capita, a measure of each country s average labor costs

Unit Cost Variation by Risk Group Scenario FSW SDC MSM Standard unit cost Key population higher cost General population higher cost Geog. Targeted AGYW AGYW $122 $122 $122 $122 $122 $122 * 1.5 = $183 $122 $183 $122 $122 $122 $183 $122 $183 $183 30

Unit cost sensitivity analysis demonstrates change in cost-effectiveness by risk group Number of HIV Infections Averted 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Cost-Effectiveness, HIV Infections Averted, and Total Cost of PrEP Program by Risk Group, 2018-2030 $182M $129M $96M $548M $47M $0 $20,000 $40,000 $60,000 Cost per HIV Infection Averted (USD) FSW SDC MSM Geog. Targeted AGYW AGYW Standard Cost -Bubble size and data labels: Total cost of adding PrEP program, USD millions 31

Unit cost sensitivity analysis demonstrates change in cost-effectiveness by risk group Cost-Effectiveness, HIV Infections Averted, and Total Cost of PrEP Program by Risk Group, 2018-2030 Number of HIV Infections Averted 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 $548M $182M $194M $96M $71M $0 $20,000 $40,000 $60,000 Cost per HIV Infection Averted (USD) FSW SDC MSM Geog. Targeted AGYW AGYW KP Higher Cost -Bubble size and data labels: Total cost of adding PrEP program, USD millions 32

Unit cost sensitivity analysis demonstrates change in cost-effectiveness by risk group Number of HIV Infections Averted 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Cost-Effectiveness, HIV Infections Averted, and Total Cost of PrEP Program by Risk Group, 2018-2030 $182M $129M $96M $548M $47M $0 $20,000 $40,000 $60,000 Cost per HIV Infection Averted (USD) FSW SDC MSM Geog. Targeted AGYW AGYW Standard Cost -Bubble size and data labels: Total cost of adding PrEP program, USD millions 33

Unit cost sensitivity analysis demonstrates change in cost-effectiveness by risk group Number of HIV Infections Averted 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Cost-Effectiveness, HIV Infections Averted, and Total Cost of PrEP Program by Risk Group, 2018-2030 $129M $273 $144M $47M $821M $0 $20,000 $40,000 $60,000 Cost per HIV Infection Averted (USD) FSW SDC MSM Geog. Targeted AGYW AGYW GP Higher Cost -Bubble size and data labels: Total cost of adding PrEP program, USD millions 34

How would varying levels of adherence by risk group affect the relative impact and cost-effectiveness of providing PrEP to the different risk groups?

Total target population PrEP Cascade Service availability Screening uptake PrEP eligibility PrEP uptake PrEP retention PrEP discontinuation Refer for ART HIV+ HIV- PrEP re-initiation

Lower Adherence Averts Fewer Infections HIV Infections Averted 50,000 40,000 30,000 20,000 10,000 Cost-Effectiveness and Impact of PrEP Program by Adherence Scenario, 2018-2030 0 $- $10,000 $20,000 $30,000 Cost per Infection Averted (USD) High (80%) Medium (50%) Low (30%) High FSW (80%), Med GP (50%) Med FSW (50%), High GP (80%) 37

Discussion and Next Steps 38

Strengths of the Modeling Approach Combines the more detailed risk structure of the Incidence Patterns Model (IPM) with the dynamic projections and HIV interventions in the Goals model Incorporation of risk groups not previously modeled in Goals: serodiscordant couples, adolescent girls and young women Dynamic modeling can take into account projected changes in HIV incidence from scaling up ART and other HIV prevention interventions Use of rigorous data from published DHS and AIS surveys to disaggregate HIV incidence by risk group PrEP workbook allows users flexibility in defining rates and levels of scale-up of PrEP, target populations, unit costs, etc. while automating the communication between the IPM and Goals models 39

Limitations of the Analytic Process Uncertainty in estimates of HIV incidence by subpopulation and geographic unit Cost-effectiveness between risk groups cannot be compared at the provincial or regional level Unknown or uncertain population sizes for various risk populations will make determination of targets and coverage uncertain Limited primary data are available on cost of oral PrEP Even less is known about cost variations by setting, service delivery model, and subpopulations This introduces uncertainty into analyses of relative cost-effectiveness of oral PrEP overall and of providing oral PrEP to different risk groups Cannot model changes in individual risk characteristics over time; average population characteristics are modeled instead Modeling team cannot provide prioritization and targets at a district level during this phase of model development 40

Possible Future Work Countries can request customized modeling exercises with full stakeholder engagement Countries can refine the modeling estimates by collecting data on: PrEP costs, coverage, and adherence by risk group or service delivery method HIV incidence for key and priority populations Key and priority population sizes The modeling team is proposing developing an implementation tool that assists decision-makers to: Generate PrEP numeric targets by risk group and district Incorporate detailed cost and implementation data as they become available to refine cost projections 41

Discussion Scenarios Given these results, which populations should be prioritized for oral PrEP? Should oral PrEP be rolled out to some populations before others, or simultaneously? What about geographic prioritization? Are there different modeling scenarios that would be helpful? 42

Acknowledgements The team thanks the Ministry of Health in Lesotho, Mozambique, Swaziland, and Uganda, PEPFAR country teams, and USAID Washington (Delivette Castor, Elizabeth Russell, and Sangeeta Rana) for their support of this work. The Oral PrEP Workbook was developed by Carel Pretorius, with support from Yu Teng and Robert Glaubius of Avenir Health and Juan Dent of Palladium HP+/Project SOAR PrEP modeling team: Katharine Kripke, HP+ Activity Manager kkripke@avenirhealth.org Steven Forsythe, Project SOAR Activity Manager sforsythe@avenirhealth.org Juan Dent, Juan.Dent@thepalladiumgroup.com Robert Glaubius, RGlaubius@avenirhealth.org Matthew Hamilton, mhamilton@avenirhealth.org Guy Mahiane, GMahiane@avenirhealth.org Carel Pretorius, cpretorius@avenirhealth.org Meghan Reidy, mreidy@avenirhealth.org Melissa Schnure, Melissa.Schnure@thepalladiumgroup.com Yu Teng, YTeng@avenirhealth.org 43

Health Policy Plus (HP+) is a five-year cooperative agreement funded by the U.S. Agency for International Development under Agreement No. AID-OAA-A-15-00051, beginning August 28, 2015. The project s HIV activities are supported by the U.S. President s Emergency Plan for AIDS Relief (PEPFAR). HP+ is implemented by Palladium, in collaboration with Avenir Health, Futures Group Global Outreach, Plan International USA, Population Reference Bureau, RTI International, ThinkWell, and the White Ribbon Alliance for Safe Motherhood. Project SOAR (Cooperative Agreement AID-OAA-14-00026) is made possible by the generous support of the American people through the United States Agency for International Development (USAID). The contents of this presentation are the sole responsibility of the SOAR Project and Population Council and do not necessarily reflect the views of USAID or the United States Government. Through operations research, Project SOAR will determine how best to address challenges and gaps that remain in the delivery of HIV and AIDS care and support, treatment, and prevention services. Project SOAR will produce a large, multifaceted body of high-quality evidence to guide the planning and implementation of HIV and AIDS programs and policies. Led by the Population Council, Project SOAR is implemented in collaboration with Avenir Health, Elizabeth Glaser Pediatric AIDS Foundation, Johns Hopkins University, Palladium, and The University of North Carolina. This presentation was produced for review by the U.S. Agency for International Development. It was prepared by HP+. The information provided in this presentation is not official U.S. Government information and does not necessarily reflect the views or positions of the U.S. Agency for International Development or the U.S. Government.