Transforming Intermittent Preventive Treatment for Optimal Pregnancy (TIPTOP )

1. Transforming Intermittent Preventive Treatment for Optimal Pregnancy (TIPTOP) Module 9 Version 2

2. Learning objectives • By the end of this module, learners will be able to: • Describe Unitaid and what it does • Describe the TIPTOP project: • Rationale • Project countries • Goal and expected outcomes • Outputs, activities, and assumptions • Implementation strategy, preconditions, and timelines • Stakeholder engagement • External communication approach • Transition and scale-up strategy

3. What is Unitaid and what does it do? • Innovator for global health • International “hosted partnership” of the World Health Organization (WHO): • Acts as investor/donor seeking faster and cheaper ways to prevent and treat: • HIV, tuberculosis, and malaria • Planning to integrate maternal, newborn, and child health in future • Key funding comes from air ticket levy

4. What is Unitaid and what does it do? (cont.) • Unitaid 2017–2021 strategic plan objectives: • Promote innovation • Catalyze equitable access to better health products • Create the right conditions for scale-up • More information at https://unitaid.org/#en

5. Source:Unitaid. 2017. Innovating for global health. Unitaid website. https://unitaid.eu/assets/Innovating-for-global-health-23102017.pdf. Accessed November 6, 2018.

6. Why is TIPTOP important? • Jhpiego is leading a new pathway for malaria in pregnancy (MiP) by: • Driving impact in target countries and regionally to help countries significantly increase coverage • Bending the curve, reaching the hardest to reach • Steering global, regional, and country-level advancement in addressing MiP

7. What is TIPTOP doing? Research Generating evidence. Ensuring equitable access to medicine. Setting the stage for scale-up. Quality-assured SP c-IPTp implementation Introducing, testing, and expanding community-directed intermittent preventive treatment in pregnancy (c-IPTp) with quality-assured sulfadoxine-pyrimethamine (SP).

8. Who makes up the TIPTOP partnership? • Jhpiego: Principal recipient (prime) and implementing partner • Barcelona Institute for Global Health: Research partner • Enabler partners (self-managed budgets): • Medicines for Malaria Venture (MMV):Bringing quality-assured SP to market • WHO:SP drug resistance surveillance (DRS),advocacy, and coordination/collaboration

9. Where does TIPTOP operate? Selection criteria: • National policy on intermittent preventive treatment in pregnancy (IPTp) • Community health worker (CHW) policy • Ministry of health (MOH) commitment • Availability of insecticide-treated bed nets or long-lasting insecticidal nets (ITNs/LLINs) at antenatal care (ANC) • Strong relationship between MOH malaria control and reproductive health divisions • Democratic Republic of the Congo (DRC) • Madagascar • Mozambique • Nigeria

10. TIPTOP’s theory of change Project rationale Public health need • The unacceptably low proportion of eligible pregnant women (PWs) receiving IPTp with quality-assured SP (IPTp first dose [IPTp1] 52% and IPTp3 17%) leaves millions of PWsunprotected from malaria, contributing to preventable maternal and neonatal morbidity and mortality. • Supply: Insufficient a) availability and access to quality-assured SP, b) manufacturers of quality-assured SP. • Demand: Insufficient demand for quality-assured SP (e.g., perception of SP as “failed drug”) Market failure Results chain Inputs Activities Outputs Outcomes Impacts • Unitaid funds • Training materials • Supervision Guide • SP package prototype • SP forecast tool • Training: trainers, supervisors, CHWs, facility providers • Technical assistance to SP manufacturers • Advocacy • Trained CHWs • Coverage of trained CHWs • CHWs supervised • Women received c-IPTp • IPTp3, IPTp2, IPTp1 uptake increased • Fewer stock-outs • ANC rates remain the same • Country budget allocation for IPTp • Evidence for global guidance generated • Neonatal mortality reduced • Maternal lives saved • Disability-adjusted life years averted • Costs saved • Introduction of c-IPTp with SP could overburden CHW. • Policy barriers inhibit c-IPTp distribution by CHW • ANC attendance declines because of community distribution of SP • Lack of quality-assured SP at project startup. Key risk • Criticism of SP efficacy causes MOH to prioritize other interventions and deprioritize MiP

11. TIPTOP goal and expected outcomes Goal: To contribute to reduced maternal and neonatal mortality in project areas by expanding access to quality-assured SP for IPTp Increased IPTp3 to a minimum of 50% Without decreased ANC attendance

12. Expected outputs • Demonstrated and fully implemented c-IPTp with SP • Improved supply of quality-assured and adapted-packaging SP—through a supply-side agreement with MMV • Established environment that supports transition of TIPTOP to MOH for scale-up and sustainable c-IPTp with SP • Developed and disseminated global recommendations and guidance for delivery of c-IPTp with SP

13. Community-to-clinic continuum of care approach • ANC • ANC and MiP performance standards reinforced • Assessmentof early gestational age • Community • Provide IPTp with SP doses to eligible PWs • Counsel on benefits of comprehensive ANC • ReferallPWs to ANC • Training • Supervision • Mobilization • Commodities • Referrals • Records • Feedback No missed opportunities approach

14. The TIPTOP approach • Comprehensive ANC • Minimum of eight ANC contacts • Estimation of gestational age • Nutritional supplements • IPTp by directly observed therapy • ITN/LLIN distribution • Malaria case management • Tetanus toxoid immunization • HIV testing and counseling • Counseling on danger signs • Management of common ailments in pregnancy • Early detection and treatment of pregnancy complications Social and behavior change communication Mozambique: lay community counselors CSOs Health care worker ANC CHW Abbreviation:CSO, civil society organization. PW

15. Participating country policy on CHWs role in SP distribution CHWs give first and follow-up doses of SP Assessment for eligibility to receive SP doses • DRC • Nigeria Referral • Madagascar • Mozambique CHWs only give follow-up doses of SP PW CHW

16. TIPTOP phases Phase 1: • Approximately 2 years • Demonstration of c-IPTp • Approximately 10,000 PWs per country • Research • Introduction of quality-assured SP for IPTp Phase 2: • Approximately 3 years • Expansion of c-IPTp • Approximately 30,000 PWs per year per country • Research • Demand creation for quality-assured SP for IPTp

17. Approach • Community-to-clinic continuum of care model • Promote early and comprehensive ANC attendance • CHWs will meet with PWs monthly: • Provide IPTp with SP to eligible PWs • Counsel on comprehensive care including use of ITNs/LLINs and effective malaria case management • Refer to ANC for additional services • WHO’s 2016 ANC recommendations reinforce this model.

18. Implementation • Output 1: Demonstration and fully implemented community-based IPTp with SP: • Advocacy at national level • Implementation in target sites, leveraging other partner support • Demand creation • Availability of quality-assured SP at point of care

19. Commodity • Output 2:* Improved SP supply and quality: • Secured WHO prequalification for quality-assured SP • Development of drug packaging promoting IPTp with SP • Strengthening of SP product demand forecast • Jhpiego will procure quality-assured SP (links to output 2) in Years 1, 2, and 3 *Led by MMV

20. Enabling environment • Output 3: Environment established to support transition to MOH for scale-up and sustainable c-IPTp with SP: • Coordination and collaboration with key partners • Sustainability planning from the beginning • Expansion of program learning

21. Research: This project will directly influence change in WHO global MiP policy • Output 4:* Development and dissemination of global recommendations and guidance for delivery of c-IPTp with SP: • Household surveys: • IPTp uptake • ANC utilization • Anthropological studies: • Client and provider perceptions • SP DRS • Economic evaluations: • Costs and savings *Led by Barcelona Institute for Global Health

22. Project risks

23. Stakeholder engagement • Setting the stage for handover/sustainability • Country operational plans developed through discussions with and input from key stakeholders, such as: • National malaria control or elimination programs • MOH reproductive health divisions • President’s Malaria Initiative (PMI) • Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM)

24. Stakeholder engagement, cont. • Consensus-building meetings at the national, subnational, district, and community levels • Further strengthening of national and subnational MiP technical working groups (TWGs) • Memorandums of understanding with key CSOs to help mobilize support at the community level

25. Collaborating with key partners • Working with PMI, GFATM, and other partners through existing projects and national TWGs to complement ongoing MiP technical assistance and engender strong coordination • Continued collaboration with key partners through ongoing check-ins on overall progress success, opportunities, and bottlenecks • Coordination and collaboration with any previous c-IPTp pilot • Continued leadership, engagement, and coordination with Roll Back Malaria’s MiP Working Group and existing maternal and child health programs

26. External communication planStrong communication measures will support and disseminate project learning Objective: Increase understanding of project evidence, successes, and lessons learned

27. Beyond the life of the project • Transition and scale-up: • WHO policy change after TIPTOP project results are presented to the WHO IPTp evidence review group • Country adoption of c-IPTpinto national malaria strategic plan and national policies • Increased availability of quality-assured SP in all TIPTOP project countries • Increased IPTp and ANC coverage in malaria-endemic countries across the region • c-IPTp included in PMI Malaria Operational Plans • c-IPTp included in country applications for GFATM grants

28. References • Brieger W, Orji B, Otolorin E, Ndekhedehe E, Nwadike J. 2011. Establishing integrated community management of malaria, pneumonia and diarrhea in two selected local government areas, AkwaIbom State, Nigeria. Presented at: American Society of Tropical Medicine and Hygiene Annual Meeting; December 6; Philadelphia, PA. http://reprolineplus.org/system/files/resources/Establishing%20Integrated%20Community%20Management%20of%20Malaria%20Handout%20v3.pdf. Accessed November 13, 2018. • World Health Organization (WHO). 2016. WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva, Switzerland: WHO. http://apps.who.int/iris/bitstream/10665/250796/1/9789241549912-eng.pdf?ua=1. Accessed November 13, 2018.

29. Thank you! Any questions or comments?