The remaining research agenda: from controlled trials to effective programs

Presented by: Pierre Lacerte Health Advisor / Maternal and Newborn Health and Nutrition Program Manager in Africa Dhaka, 3rd May , 2012

Background and motivation for this presentation

Evidence for the efficacy of calcium supplementation to reduce risk of preeclampsia is strong Generated from randomized controlled trials in multiple settings First interventions shown to be effective for prevention Particularly relevant in context where emergency obstetric care may be weak. Systematic reviews to explore overall impact form basis of guidelines now developed by WHO A number of practical questions remain, answers to which would strengthen the capacity to design and implement programs Evidence base would be strengthened by program evaluations, complementary to that generated in randomized trials

Impact of interventions dependant on multiple factors

Impact Nutritional Need + Coverage + Utilization
NEED

Utilization Uptake + Knowing benefits & how to use + External motivation External Factors Socio-cultural Technical Economic Political

Coverage Provision + Uptake by those in need Provision Quantity Quality Timeliness

Uptake Awareness Attitude Accessibility

Contextually relevant package of interventions

Objectives of this presentation To explore some topics related to calcium supplementation that would be strengthened by additional biological and implementation research To initiate a discussion on appropriate ways to move programs forward while awaiting this additional evidence

To update on some advances being made on the

research agenda

Some of the challenges that we have seen for IFA programs likely to be similar for Calcium supplementation programs
Demand side: Contact with women may begin only late in pregnancy Irregular contact may limit effective coverage, opportunities for encouragement to comply Possible issues with uptake and compliance Supply side: Budget allocation donor dependency Poorly functioning supply chains

Some of the challenges that we have seen for IFA programs likely to be similar for Calcium supplementation programs
Demand side: Contact with women may begin only late in pregnancy Irregular contact may limit effective coverage, opportunities for Although well recognized, many of these encouragement to comply issues have not been adequately addressed Possible issues with uptake and compliance for IFA programs. Now we should: Supply side: Avoid Ca programs likely to suffer from Budget allocation similar dependency donor supply and demand-side problems Poorly functioning supply chains to renew efforts to Take advantage strengthen IFA and Ca programs simultaneously

Additional challenges
Identification of populations with low calcium intakes in context where dietary data is, at best, scarce Calcium supplements may inhibit absorption of MIs Maternal and Neonatal Health and Nutrition iron, depending Program and iron source on dose Calcium and Iron share gastrointestinal side effects that might limit adherence

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Some lessons learnt and common sense responses to these challenges

Intense and effective training will be required for health care providers Motivation to accept and implement program effectively, including supply management and communication with Neonatal Health and MIs Maternal and pregnant women
Nutrition Program

Effective behaviour change communication Requires an understanding of the barriers and factors that would facility uptake and adherence

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MIs maternal and neonatal health and nutrition initiatives

Goal: Develop, implement and evaluate demonstration projects, in line with country priorities and current activities, to increase the coverage and quality of community based interventions to improve maternal and neonatal survival and health, ensuring the inclusion of appropriate and innovative nutrition and specifically micronutrient interventions. 4 Focus countries: Ethiopia Kenya Senegal Niger
MIs Maternal and Neonatal Health and Nutrition Program

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MI identified this as a critical opportunity to invest in research related to calcium supplementation for pregnant women
Main Objective : Develop and test evidence-based strategies for implementing calcium supplementation during pregnancy for the prevention of pre-eclampsia and eclampsia in settings with low rates of dietary calcium intake and weak health systems.
MIs Maternal and Neonatal Health and Ultimate Outcome: Policy makers, program developers and managers have Nutrition Program accurate and complete information of the potential barriers and factors that would facilitate implementation and acceptance of calcium and IFA supplementation programs and use that information to design effective programs

Partner: MI, Cornell University and the partners involved in MIs demonstration projects in Ethiopia (Ministry of Health, Emory University) and Kenya (Ministry of Health, AMREF and PRONTO International)

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Project to be implemented in 2 phases to address specific challenges for program design:

Challenge 1: Low uptake of IFA, low antenatal care coverage and late and infrequent contact with health care system Research objective 1: To identify an optimum delivery platform for Ca and IFA supplementation based on barriers and facilitating factors for delivery, demand and adherence, and data on health system capacity for effective management and delivery of supplies. Challenge 2: Poor compliance with IFA supplementation currently, potentially greater risks with addition of calcium (larger, additional tablet, side effects etc.) Research objective 2: Collect and assimilate information on the perspectives of health care providers and beneficiaries that is needed to design effective behaviour change communication to support demand, implementation, utilization, and adherence for Ca and IFA supplementation. Research objective 3: Design models for delivery and promotion of Ca and IFA supplements in pregnancy. Identify remaining questions on supplement delivery, training, messages, and materials that should be tested in pilot study using process and outcome evaluation and develop protocols for pilot project
, 2006.

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A sampling of the issues that will be addressed:

Specification of Ca and IFA supplement formulation (interactions, dosing, packaging, cost, etc) Forecasting and management plan for ensuring adequate distribution and stocking of supplies Development of protocols and checklists for integrating Ca and IFA supplementation into ANC services at all relevant levels of the health system BCC strategies and materials for stimulating demand among potential beneficiaries, and motivating and sustaining adherence to supplements Training for health care providers in supplement delivery and communication Training for supervision and monitoring of implementation
, 2006.

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Phase 2 will include pilot testing the new delivery model in both countries
Objective 1: Test models developed in Phase 1 by implementing Ca and IFA supplementation within the health system in a small number of project sites selected in conjunction with MOH in Kenya and Ethiopia. Objective 2: Evaluate the implementation process and effectiveness of the model strategies. Objective 3: Refine models and make recommendations for improving implementation and effectiveness. Objective 4: Disseminate results to provide policy makers, program developers and health care providers with information needed on the value of and best practices for implementation of Ca and IFA supplementation during pregnancy.
, 2006.

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Timeline and some implications for current program efforts

The MI project will take time Should not impede program development in other countries Programs in all countries should invest in the formative research and information collection that will ensure appropriate program design in their context: Innovative alternatives for delivery (particularly if IFA programs have not been successful) Identification and resolution of forecasting and supply chain issues Effective training for health care providers Relevant and effective communication to promote program uptake and utilization by pregnant women