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Male Circumcision for HIV Prevention: Progress in Scale-up Dr. Kim Eva Dickson Medical Officer, Male Circumcision for HIV Prevention: Progress in Scale-up Dr. Kim Eva Dickson Medical Officer, HIV Department Prevention in the Health Sector Unit World Health Organization Geneva, Switzerland CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Overview • Research on MC for HIV prevention and other STI's • The global Overview • Research on MC for HIV prevention and other STI's • The global recommendations • The potential cost and impact of scaling up MC for HIV prevention • Country progress in of MC programmes • Opportunities and challenges • Conclusions CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Research • 4 ecological studies • 35 cross-sectional studies • 14 prospective studies • Research • 4 ecological studies • 35 cross-sectional studies • 14 prospective studies • 3 randomized controlled trials Confirm that male circumcision provides approximately 60% protection against HIV CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Impact on HIV incidence: Evidence from observational studies and RCTs Effect size Study (95% Impact on HIV incidence: Evidence from observational studies and RCTs Effect size Study (95% CI) Overall 0. 42 ( 0. 34, 0. 52) High-risk groups 0. 29 ( 0. 20, 0. 42) General Population 0. 56 ( 0. 44, 0. 71) South Africa 0. 40 ( 0. 24, 0. 67) Kenya 0. 41 ( 0. 24, 0. 70) Uganda 0. 49 ( 0. 28, 0. 86) . 15 . 2 . 3 . 4 . 5 1 1. 5 Effect size CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Research – Non HIV Benefits Male Circumcision provides: – partial protection against GUD Bailey Research – Non HIV Benefits Male Circumcision provides: – partial protection against GUD Bailey IAS 2007, PLo. S Med 2009, 6: e 1000187 – Partial protection against HPV Tobian et al, NEJM 2009, Auvert et al, JID 2009 – Protects against HSV-2 acquisition Sobngwi-Tambekou et al, JID 2009; Tobian et al, NEJM 2009 – Little protection against urethral infections – Some evidence of a protection against vaginal infections (TV, BV, GUD) in women Gray et al, Am. J. Obstet. Gynecol 2009 • The effect of circumcision on HIV in men is largely independent of the impact on STI CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Recent Research Data • Male to female transmission – Among HIV-1 serodiscordant couples in Recent Research Data • Male to female transmission – Among HIV-1 serodiscordant couples in which the male was HIV +ve, there was no increased risk and potentially decreased risk from MC on male-to- female transmission of HIV-1 (HR 0. 63, 95%CI 0. 35 – 1. 10) Baeten JM et al, AIDS. 2009. Dec [Epub ahead of print] • Effects of MC on penile microbiota – MC associated with a significant decrease in anaerobic bacterial families. This may play a role in protection from HIV and other STIs (in males and females) Price et al, PLo. S One. 2010. 5: e 8422 CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

The Global Recommendations WHO/UNAIDS Technical Consultation Male Circumcision and HIV Prevention: Research Implications for The Global Recommendations WHO/UNAIDS Technical Consultation Male Circumcision and HIV Prevention: Research Implications for Policy and Programming Montreux, 6 - 8 March 2007 CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Global Recommendations • Countries with high prevalence (>15%), generalized heterosexual HIV epidemics and low Global Recommendations • Countries with high prevalence (>15%), generalized heterosexual HIV epidemics and low rates of MC should consider urgently scaling up access to MC services • 13 countries identified: Botswana, Kenya, Lesotho, Malawi, Mozambique, Namibia, Rwanda, South Africa, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe • Consider ethics, communication, culture, health systems, funding, gender, comprehensive prevention strategies CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Impact of MC Scale-up PLo. S Medicine 2009 doi: 10. 1371/journal. pmed. 1000109. g Impact of MC Scale-up PLo. S Medicine 2009 doi: 10. 1371/journal. pmed. 1000109. g 001 CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Cost and Impact of MC Scaling up of MC to reach 80% of adult Cost and Impact of MC Scaling up of MC to reach 80% of adult and newborn males in 14 African countries by 2015: • Could prevent more than 4 million adult HIV infections over 15 years (2009 – 2025) • Could result in cost savings of US$20. 2 billion between 2009 – 2025 with an overall investment of approx *US$ 4 billion • Would require almost 12 million MCs to be performed in the peak year, 2012 Source (* adapted): USAID/HPI (2009) The Potential Cost and Impact of Expanding Male Circumcision in Eastern and Southern Africa CROI 2010 http: //www. malecircumcision. org/research/policy_briefs. htm 17 th Conference on Retroviruses and Opportunistic Infections

Botswana MC Program Costs and Cost Savings (Estimates) Adapted from: USAID/HPI (2009) The Potential Botswana MC Program Costs and Cost Savings (Estimates) Adapted from: USAID/HPI (2009) The Potential Cost and Impact of Expanding Male Circumcision in Botswana http: //www. malecircumcision. org/research/policy_briefs. htm CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Almost Three years later…… What Progress has been made…? ? ? 2007 March Montreux Almost Three years later…… What Progress has been made…? ? ? 2007 March Montreux Meeting WHO/UNAIDS Recommendations 2008 2009 2010 CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Progress made on Male Circumcision to end 2009 Male circumcision prevalence at country level, Progress made on Male Circumcision to end 2009 Male circumcision prevalence at country level, 2006 Kenya Policy, strategy, Training, QA, expanded service delivery, M&E Rwanda Situation analysis, pilot service delivery in military South Africa, Zimbabwe Situation analysis, draft policy, pilot sites Namibia Draft policy, draft communications strategy, draft M&E Lesotho Situation analysis, policy development underway, draft strategy Uganda Situation analysis, policy development Tanzania, Mozambique, Malawi Situation analysis, pilot sites Zambia Policy note, Strategy, national and regional trainings Botswana Situation analysis, strategy, communications, training, expanded service delivery, M&E Swaziland Policy, strategy and implementation plan, QA CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Advocacy • Advocacy for MC has been vibrant at global, regional and country level…. Advocacy • Advocacy for MC has been vibrant at global, regional and country level…. • Regional MC experts meetings in May 2007 to review recommendations, another meeting in April 2008 in response to Africa Ministers of Health request • Country level advocacy through joint UN and partner Missions • Multi stakeholder consultations in all countries with key stakeholder group consultation e. g. traditional leaders in Lesotho and Kenya; women's groups in Zimbabwe CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Leadership and Partnerships • Country Champions have provided leadership to accelerate progress - Botswana: Leadership and Partnerships • Country Champions have provided leadership to accelerate progress - Botswana: Ex- President Festus Mogae - Kenya: Prime Minister Raila Odinga with Luo Council of elders • National Task Forces in all countries • Global level UN - WHO with UNAIDS, UNICEF, UNFPA • Funding Agencies rapidly making funds available; PEPFAR, Gates, GFATM • Partnerships to support scale-up: MC Partnership (PSI, Marie Stopes International, Jhpiego) MC Consortium (FHI, Engender. Health, University of Illinois Chicago, Nyanza RHS) CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Situation Analysis • A situation analysis is to determine attitudes, beliefs, practices and socio Situation Analysis • A situation analysis is to determine attitudes, beliefs, practices and socio cultural aspects of MC, policy and regulatory framework, health system readiness • Comprehensive situation analyses completed in Botswana, Lesotho, Malawi, Namibia, Uganda, Zambia, Zimbabwe • Rapid assessments in Swaziland (Key informants, Facility readiness), Rwanda (facility readiness) CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Policy Notable flexibility in approach to policy development: • Botswana no separate policy but Policy Notable flexibility in approach to policy development: • Botswana no separate policy but strategy with policy elements • Zambia sent Information note to Cabinet • Kenya developed policy guidelines • Dedicated policies developed in Lesotho, Namibia, South Africa, Swaziland, Uganda and Zimbabwe (drafts completed) CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Strategy • Country strategies developed that include: – Objectives, target population, numbers of men Strategy • Country strategies developed that include: – Objectives, target population, numbers of men to be reached, costs, service delivery strategies, resource mobilization, monitoring and evaluation • Decision Makers' Programme Planning Tool to estimate cost, impact, pace of scale up • Most countries have 'catch-up' strategies to reach adult men – Botswana, Kenya, Swaziland, Zimbabwe, Zambia • But longer term neonatal circumcision strategies also being considered in Botswana, Swaziland, Zambia CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

MC Strategy - Kenya • MC integrated into National AIDS Strategic Plan III with MC Strategy - Kenya • MC integrated into National AIDS Strategic Plan III with goal to increase the proportion of men ages 15 -49 years who are circumcised in Kenya from 84 percent to 94 percent by 2013 – Aim that each region reaches coverage of 80% by 2013 – Improving safety of MC nationally, including in traditional settings – Reduce risk compensation disinhibition • MC targets translated into actual figures- 150, 000 per year for 5 years - to 'catch-up' • MC expected to contribute to the reduction of new infections by half by 2013 (KNASP III goal) • Resources to provide MC to 750, 000 men over 5 years approximately US$ 37 -56 Million over 5 yrs CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Progress in other Key Elements • Quality Assurance being implemented in Kenya, and Swaziland Progress in other Key Elements • Quality Assurance being implemented in Kenya, and Swaziland using WHO Guide and Toolkit • Training programmes implemented in almost all countries • Communication strategies under development in Kenya, Namibia, Swaziland – UN Toolkit under development • M&E Indicators gradually being introduced into routine systems in Botswana, Kenya CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Service Delivery How many circumcisions have been done? CROI 2010 17 th Conference on Service Delivery How many circumcisions have been done? CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

MC Service Delivery Update, Jan 2010 Country Botswana Kenya South Africa Swaziland Zambia Zimbabwe MC Service Delivery Update, Jan 2010 Country Botswana Kenya South Africa Swaziland Zambia Zimbabwe Begin date Apr 2009 Sept 2008 Jan 2008 July 2009 May 2009 No. of MC's 4326 90 396 14 253 5122 16 801 3000 No. of MCs Nov – Dec 09 580 36 000 1547 1816 6171 1510 CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Kenya Rapid Results Initiative • Approx 36, 000 MCs done in 30 working days Kenya Rapid Results Initiative • Approx 36, 000 MCs done in 30 working days in 11 districts – Number of teams varied on a daily basis from 88 at start to 95 at end – MCs per team varied on a daily basis – lower at start to higher at end • Average MCs/team = 9. 6 • Highest MCs/team = 22. 8 • Approx cost per MC = $30 (versus $50+ outside of RRI) CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Snapshot of Country Progress, Jan 2010 Situat ion National Analysis Coordinator Task Force Qualit Snapshot of Country Progress, Jan 2010 Situat ion National Analysis Coordinator Task Force Qualit y Service Traini ng Policy M&E Assurance Delivery Botswana Kenya Lesotho Malawi Mozambique Namibia Rwanda South Africa Swaziland Tanzania Uganda Zambia Zimbabwe CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Status of MC Scale-up in the US • Consultation held in Atlanta – April Status of MC Scale-up in the US • Consultation held in Atlanta – April 2007* – External partners, broad range of subject matter experts, clinicians, academicians, and public health practitioners – Issues were around neonatal circumcision, other health benefits, cost/equity, relevance to MSM *Smith DK, et al. Male circumcision in the United States for the prevention of HIV infection and other adverse health outcomes: report from a CDC consultation. Public Health Reports 2010 • Draft currently in CDC clearance • Simultaneous reviews (mid 2010) • Final version to incorporate input and published as MMWR Recommendations & Reports CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Challenges and Constraints • Human resource constraints for country programming at national level, staff Challenges and Constraints • Human resource constraints for country programming at national level, staff already overloaded • Gaining political support – it has been a process to get political buy-in in some countries, also delays due to elections, set backs with change of government • Funding – countries not clear on what funds are available and how to access • Traditional providers – almost all countries have them but no clear guidance on how to involve them • Implications for women – how to monitor and evaluate for adverse societal effects CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Challenges and Constraints Service delivery challenges: • Human resource constraints - lack of personnel, Challenges and Constraints Service delivery challenges: • Human resource constraints - lack of personnel, staff mobility, staff burnout, task shifting not permitted in countries • HIV testing – promoting the uptake of testing prior to MC • HIV positive men – how service delivery sites can handle without stigma and discrimination • Demand creation – matching services to demand • Communication – communicating partial protection, risk compensation CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Many Constraints but…. . 'If you are building a house and a nail breaks, Many Constraints but…. . 'If you are building a house and a nail breaks, do you stop building, or do you change the nail? ' Rwanda CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Apply Lessons Learned to Scale-up Because A stick is straightened while still young …. Apply Lessons Learned to Scale-up Because A stick is straightened while still young …. Uganda CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Lessons Learned • Political commitment accelerates progress • Country Champions make a difference • Lessons Learned • Political commitment accelerates progress • Country Champions make a difference • Early engagement and consultation of key stakeholders prevents set backs • Service delivery needs 'innovations' if scale-up is to be achieved e. g. task shifting/sharing, volunteers, devices, demand creation CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

Lessons Learned • Development of tools and guidelines give direction to countries and help Lessons Learned • Development of tools and guidelines give direction to countries and help to focus technical support • Subtle country peer pressure through experiences sharing helps to motivate countries to action • Funding 'provides oil to the wheels' - PEPFAR, Gates, GFATM • Leadership and coordination is critical CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections

CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections CROI 2010 17 th Conference on Retroviruses and Opportunistic Infections