VMMC LANDSCAPE IN EASTERN AND SOUTHERN AFRICA: PAST, PRESENT, FUTURE EMMANUEL NJEUHMELI, MD, MPH, MBA OFFICE OF HIV/AIDS, GLOBAL HEALTH BUREAU USAID WASHINGTON AIDS 2016 CONFERENCE, DURBAN, SOUTH AFRICA JULY 20, 2016 AIDS 2016

PRESENTATION OVERVIEW Where did we come from? Evidence to action What progress have we made? Progress toward targets and impact Challenges along the way Where are we going? JULY 20, 2016

WHERE DID WE COME FROM? JULY 20, 2016 AIDS 2016

The last time we all gathered in Durban for the international AIDS conference was in the year 2000. At that meeting, scientists debated over what to do about an interesting, yet puzzling observation—that circumcised men are much less likely to become infected than uncircumcised men… http://www.nytimes.com/2000/07/11/world/mystery-factor-is-pondered-at-aids-talk-circumcision.html

SCIENTIFIC EVIDENCE Biological plausibility: Inner surface of the foreskin highly vulnerable to HIV infection [1] Over 50 ecological and observational studies: lack of male circumcision associated with higher HIV in men [2] Three RCTs in Kenya, Uganda, South Africa: 60% protection [3,4,5] Longer-term (4–5 years) follow-up of the Kenya and Uganda RCT participants: protective effect sustained/increased [6] Community-level impact evaluation in South Africa (Orange Farm) demonstrated 76% incidence reduction [7] Researchers confirm in real-world settings in Uganda that combined VMMC and ART strategies work [8] Years of data had suggested a strong link. But it wasn’t until the randomized control trials found a 60 percent protective effect that we had the evidence. UNAIDS and WHO then moved quickly to recommend scaling up VMMC. And the evidence just keeps getting stronger. Now we are back in Durban and it’s 2016. Just last week, a study came out in JAMA, conducted by Johns Hopkins, which found that increasing the number of men who undergo circumcision and increasing the rates at which women with HIV are given antiretroviral therapy (ART) were associated with significant declines in the number of new male HIV infections in rural Ugandan communities,. The research, in the Journal of the American Medical Association (JAMA), is believed to be the first to show that two promising prevention methods that were successful in tightly controlled clinical trial settings have real-world effects. The findings suggest that further scale-up of these programs throughout sub-Saharan Africa could slow the HIV epidemic in the region. JULY 20, 2016 AIDS 2016

“Neither the elegance of the science nor the strength of the effect predict the ease of implementation” -- David Stanton, USAID, 2009 In response to the UNAIDS recommendations, five journal collections have been published so far and numerous articles summarizing lessons learned from scale-up of the vmmc program. 1st PLOS Collection in 2011, helped us to understand the cost and impact of scaling up vmmc: The potential cost savings of scale-up are clear. An initial investment of US$1.5 billion between 2011 and 2015 to achieve 80% coverage of VMMC services in 14 countries could result in net savings of US$16.5 billion between 2011 and 2025, ..Then, the 2014 collection The 13 papers in this collection examine issues of service quality, demand creation, cost, and efficiency faced by governments, donors, and programs. Systematic, evidence-based management of programs and a dynamic culture of learning are proposed to help meet the challenges of VMMC scale-up. Recommendations include greater prioritization and funding of VMMC, strategic targeting and demand creation, a focus on programmatic efficiencies, and exploration of new technologies. Then, just last week a new modeling collection launched in PLOS, in collaboration with USAID, the World Bank, and the Bill & Melinda Gates Foundation, focuses on the next steps of the VMMC program and features new modelling articles published in PLOS ONE and PLOS Medicine aiming to help country decision-makers examine the potential effects of focusing on specific sub-populations for male circumcision services. Using these new mathematical models, it is hoped that all decision makers will be in a better position to make more-informed choices about which strategies to prioritize and where best to invest efforts to achieve goals if they are equipped with the evidence, analysis, and impact estimates for HIV prevention http://collections.plos.org/s/vmmc JULY 20, 2016 AIDS 2016

INNOVATIONS AND SUSTAINING GAINS In June 2016, the devices collection was published in JAIDS. This collection of articles presents new research that underscores the challenges and opportunities for the use of medical devices in VMMC programs, as an alternative to conventional surgical approaches. Findings highlighted in this supplement will be important as the introduction of VMMC devices continues.. Finally, a new collection in Global Health Science and Practice online journal, in collaboration with Unicef, looks at Infant medical male circumcision as an approach  to sustain the gains made from adult VMMC. This collection offers insight into a few country experiences with introduction of early infant male circumcision (EIMC) services, and highlights important considerations for policy, service delivery, costs, and demand creation. http://journals.lww.com/jaids/toc/2016/06011 http://www.ghspjournal.org/content/4/supplement_1 JULY 20, 2016 AIDS 2016

WHAT PROGRESS HAVE WE MADE? JULY 20, 2016 AIDS 2016

VMMC SCALE-UP PROGRESS AND IMPACT VMMC Progress to Date and How VMMC Fits Into UNAIDS’s 90-90-90 Target Oral Session: Bang for the Buck: Cost-Effectiveness and Modelling Thursday 21 July, 16:30 - 18:00 Session Room 2 Oral abstract: Assessing progress, impact, and next steps in rolling out voluntary medical male circumcision for HIV prevention in fourteen priority countries in eastern and southern Africa as of 2015 Will discuss: Infections averted, treatment costs averted as a result of these VMMCs WHO just released a report , reference that WHO report , and reference the progress manuscript. On bottom of the graph…The total number of VMMCs performed annually in the 14 priority countries: 2008: 21,000 (programs in only 5 countries) 2012: 1.71 million (programs started in all countries) 2013: 2.66 million 2014: 3.24 million 2015: 2.62 million Cumulative total of 11.7 million by end 2015 The greatest cumulative numbers of VMMCs were performed in Uganda (2.70 million), South Africa (2.35 million), and Tanzania (1.66 million) Greatest increase in the number of VMMCs performed occurred in 2013 JULY 20, 2016 AIDS 2016

PROGRESS TOWARD COVERAGE IN TANZANIA Progress Toward Target VMMC Coverage (%) in 11 Priority Regions of Tanzania Among Males Ages 10-29 Source: Decision Makers’ Program Planning Tool (DMPPT) 2.1 modeling by Project SOAR (Supporting Operational AIDS Research) JULY 20, 2016 AIDS 2016

CHALLENGES ALONG THE WAY Low site utilization/inefficient use of the limited resources available Reaching most at-risk men ages 15-29 years old Constantly keep safety and quality of services at high level Linkages between services (HIV+ men to care and treatment, HTC to VMMC) Planning for sustainability The program has done a great job of how to address supply side of the program, but we now understand that program needs to address two key issues related to demand creation. We have learned that low site utilization is the major driver of unit costs. The second challenge is that while younger adolescents have comprised the majority of those seeking services, it has proven more difficult to attract males over 19 years of age (the group that is at higher risk of HIV). The rapid scale up of any program requires close attention to quality and safety of services, even more so when a surgery is involved. Some SNUs have reached saturation fast than others and need to start planning (reference the editorial from 2014 plos collection) JULY 20, 2016 AIDS 2016

WHERE ARE WE GOING? JULY 20, 2016 AIDS 2016

“A POWERFUL TOOLBOX FOR ENDING THE HIV/AIDS PANDEMIC” -- Anthony Fauci and Deborah Birx, 2016 UN High-Level Meeting on Ending AIDS VMMC PrEP Condoms Innovative approaches to reduce risk of infection in young women, such as DREAMS Partnership “Together, HIV treatment and other proven prevention interventions provide a powerful toolbox for ending the HIV/AIDS pandemic. These tools include voluntary medical male circumcision, which can reduce the risk of female-to-male HIV transmission by at least 60 percent; pre-exposure prophylaxis, or PrEP, a single daily pill containing two antiHIV drugs that can reduce by 90 percent the risk that an uninfected individual will contract HIV; the use of condoms; and innovative, multidimensional approaches to decrease the risk of HIV infection in young women, such as the DREAMS Partnership, led by the President’s Emergency Plan for AIDS Relief (PEPFAR). “ JULY 20, 2016 AIDS 2016

UNAIDS-WHO Joint Strategic Action Framework for Acceleration of VMMC Scale-Up: VMMC 2021 2011: First JSAF, a 5-year framework to guide key stakeholders to coordinate efforts, accelerate increased coverage of MC (2012-2016) VMMC 2021: A people-centered approach to service delivery, appropriate packages offered to different age groups and risk profiles Calls for a sound national accountability framework and management system for expanded men’s and boys’ health programs, with VMMC at its core Two main targets aligned with the UNAIDS fast track goals: By 2012, 90% of males aged 10-29 years will have been circumcised in priority settings, and 90% of 10-29 year-old males will have accessed age-specific health services tailored to their needs JULY 20, 2016 AIDS 2016

PEPFAR HIV PREVENTION TARGETS ANNOUNCED AT UN GENERAL ASSEMBLY, SEPT By the end of 2016, PEPFAR will provide 11 million voluntary medical male circumcisions for HIV prevention, cumulatively By the end of 2017, PEPFAR will provide 13 million voluntary medical male circumcisions for HIV prevention, cumulatively JULY 20, 2016 AIDS 2016

PLEASE JOIN US THURSDAY JULY 21 18:30-20:30 FOR THIS SATELLITE EVENT IN SESSION ROOM 9 In response to the UNAIDS recommendations, five journal collections have been published so far and numerous articles summarizing lessons learned from scale-up of the vmmc program. 1st PLOS Collection in 2011, helped us to understand the cost and impact of scaling up vmmc: The potential cost savings of scale-up are clear. An initial investment of US$1.5 billion between 2011 and 2015 to achieve 80% coverage of VMMC services in 14 countries could result in net savings of US$16.5 billion between 2011 and 2025, ..Then, the 2014 collection The 13 papers in this collection examine issues of service quality, demand creation, cost, and efficiency faced by governments, donors, and programs. Systematic, evidence-based management of programs and a dynamic culture of learning are proposed to help meet the challenges of VMMC scale-up. Recommendations include greater prioritization and funding of VMMC, strategic targeting and demand creation, a focus on programmatic efficiencies, and exploration of new technologies. Then, just last week a new modeling collection launched in PLOS, in collaboration with USAID, the World Bank, and the Bill & Melinda Gates Foundation, focuses on the next steps of the VMMC program and features new modelling articles published in PLOS ONE and PLOS Medicine aiming to help country decision-makers examine the potential effects of focusing on specific sub-populations for male circumcision services. Using these new mathematical models, it is hoped that all decision makers will be in a better position to make more-informed choices about which strategies to prioritize and where best to invest efforts to achieve goals if they are equipped with the evidence, analysis, and impact estimates for HIV prevention JULY 20, 2016 AIDS 2016

ACKNOWLEDGEMENTS A special thanks to the following colleagues for their contributions to this presentation: Catherine Hankins, Amsterdam Institute for Global Health and Development Elizabeth Gold, JHCCP, HC3 Project Julia Samuelson, WHO Melissa Schnure, Project SOAR Katharine Kripke, Avenir Health, Project SOAR Lani Marquez, USAID ASSIST Project Kim Ahanda, USAID Washington Valerian Kiggundu, USAID Washington JULY 20, 2016 AIDS 2016

REFERENCES Hussain LA, Lehner T. Comparative investigation of Langerhans cells and potential receptors for HIV in oral, genitourinary and rectal epithelia. Immunology. 1995;85:475–484.  Halperin DT, Bailey RC. Male circumcision and HIV infection: 10 years and counting. Lancet.1999;354:1813–1815. Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):643-56. Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet 2007;369:657-666. Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. Erratum in: PLoS Med. 2006 May;3(5):e298. Mehta SD, Moses S, Agot K, Odoyo-June E, Li H, Maclean I, Hedeker D, Bailey RC. The long term efficacy of medical male circumcision against HIV acquisition. AIDS. 2013. doi: 10.1097/01.aids.0000432444.30308.2d. Auvert B, Taljaard D, Rech D, Lissouba P, Singh B, Bouscaillou J, Peytavin G, Mahiane SG, Sitta R, Puren A, Lewis D. Association of the ANRS-12126 Male Circumcision Project with HIV Levels among Men in a South African Township: Evaluation of Effectiveness using Cross-sectional Surveys. PLoS Med. 2013;10(9):e1001509. doi: 10.1371/journal.pmed.1001509.  Kong X, Kigozi G, Ssekasanvu J, et al. Association of Medical Male Circumcision and Antiretroviral Therapy Scale-up With Community HIV Incidence in Rakai, Uganda. Journal of the American Medical Association. 2016. JULY 20, 2016 AIDS 2016

SENIOR BIOMEDICAL PREVENTION ADVISOR enjeuhmeli@usaid.gov PHOTO BY CHAPS, SOUTH AFRICA EMMANUEL NJEUHMELI SENIOR BIOMEDICAL PREVENTION ADVISOR enjeuhmeli@usaid.gov JULY 20, 2016