The Johns Hopkins University,

Bloomberg School of Public Health

Health Research Challenge for Impact

Cooperative Agreement

with the

United States Agency for International Development

GHS-A-00-09-00004-00

Final Project Report

October 1, 2009 – September 30, 2016

Robert E. Black, MD, MPH

Principal Investigator

This report was made possible through support provided by the Office of Health, Infectious Diseases, and Nutrition, Global Health Bureau, U.S. Agency for International Development, under the terms of Award No. GHS-A-00-09-00004-00, Health Research Challenge for Impact Cooperative Agreement. The opinions expressed herein are those of the author(s) and do not necessarily reflect the views of the U.S. Agency for International Development.

TABLE OF CONTENTS

TABLE OF CONTENTS

EXECUTIVE SUMMARY

RESEARCH IN ASIA

Determining the Burden of Maternal Ill Health and Death and its Programmatic Implications in Rural Bangladesh Dissemination

Chlorhexidine (CHX) Main Trial Dissemination

Analysis of Outcomes Related to Short Inter-Pregnancy Intervals (IPI) in Projahnmo I and II (Sylhet and Mirzapur)

Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Severe Infections in Neonates and Young Infants (SAT)

Implementation research (IR) to support Bangladesh MOHFW to implement its recent policy of management of clinically suspected serious infections (CSSI) in young infants in two rural sub-districts of Bangladesh

Support for Improved Functioning of the Planning Wing and Other Departments of MOHFW, Bangladesh

Operations Research to improve the quality and coverage of services provided at community clinics in Bangladesh

Best practices, capacity-building and leadership for Maternal, Neonatal and Child Health, Family Planning and Nutrition Programs in Bangladesh

Technical Assistance Bangladesh Maternal Mortality and Morbidity Survey (BMMS)

Repeat Reproductive Age Mortality Study (RAMOS II) in Afghanistan

Systematic Documentation of Community-oriented Approaches to Improve Recognition of and Appropriate Care Seeking for Newborn and/or Maternal Complications in Sarlahi District, Nepal

RESEARCH IN AFRICA

Monitoring, Documentation and Evaluation of an Integrated Maternal and Newborn Health Care Program in Morogoro Region, Tanzania

A Learning Agenda for the Development of Community Based Programs in Tanzania: Towards the Development of a Community Health Worker (CHW) Cadre

A Verbal/Social Autopsy Study to Improve Estimates of the Causes and Determinants of Neonatal and Child Mortality in Nigeria

The Care and Treatment of Severe Pneumonia in HIV-exposed and Infected Children in Zambia

Development and Testing of Evidence-based Mental Health Treatment for Affected Youth – Zambia

Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Sub-study – Zimbabwe

Planning Activity for Confronting the Burden of Child Injury in Ethiopia

GLOBAL RESEARCH

Child Injury Experts Meeting

Assessing the Impact of Health Interventions for Non-communicable Diseases and Injuries in Low and Middle Income Countries: A user-friendly model

Implementation Research and Delivery Science (IRDS)

Community-based Approaches to Improving Reproductive, Maternal, Neonatal and Child Health Supplement Publication

ADDITIONAL SUPPORT FOR ADMINISTRATIVE EFFORTS

HRCI Administrative Core

APPENDIX: PUBLICATIONS AND MANUSCRIPTS IN PREPARATION (as of September 30, 2016)

EXECUTIVE SUMMARY


The aim of Health Research Challenge for Impact (HRCI) Cooperative Agreement (CA) was to accelerate the development and introduction of new, feasible, culturally acceptable, low cost, preventive and curative interventions for the main causes of maternal, newborn and child (MNC) deaths. To achieve this aim, the Department of International Health at the Johns Hopkins Bloomberg School of Public Health (JHBSPH) established a partnership that included the field presence and experience of Save the Children and leading research institutions in both Africa and Asia. These have included The Muhimbili University of Health and Allied Science in Tanzania (MUHAS), International Centre for Diarrhoeal Disease Research in Bangladesh (ICDDR,B), Shimantik in Bangladesh, and the National Population Commission of Nigeria, among others.

The work conducted under the auspices of the HRCI was organized into four linked components: three research areas (intervention research, program approach research and tools/measurement research) and a cross-cutting component dedicated to accelerating progress along the research to use (HARP) continuum under which the cooperative agreement was developed. This framework highlights the importance of conducting research with an eye toward national and international policy change and program implementation.

Since 2009, USAID investment in research through the Health Research Challenge for Impact (HRCI) partnership has resulted in several key advancements in maternal, newborn and child survival and has served as a key component in efforts to move along the research to practice continuum. The project has provided global leadership and the generation of robust evidence across a broad geographic and contextual scope.

HRCI played a strong leadership role in advancements in newborn health along the HARP continuum. This included leadership in the dissemination of results from three large chlorhexidine trials which led the WHO to revise its umbilical cord care recommendation for high mortality settings and which in turn has led to global scale up of chlorhexidine umbilical cord care. HRCI also supported a randomized clinical trial on the safety and efficacy of simplified antibiotic regimens for outpatient treatment of suspected severe infections in neonates and young infants (SAT). Based on the findings of this study and findings of two similar trials, the WHO revised global guidelines for the management of possible severe bacterial infections in young infants. HRCI subsequently supported implementation research to assist the Government of Bangladesh in implementing its adapted national guidelines for management of young infant infections, and to provide lessons learned to other countries looking to adapt and scale up their guidelines.

HRCI has also led the expansion of research into new geographical regions and areas of focus within maternal, newborn and child health. This had included a multiple methods reproductive age mortality study in Afghanistan, a Verbal and Social Autopsy (VASA) study in Nigeria, development and testing of evidence-based mental health treatment for affected youth in Zambia, associations with exposure to aflatoxinin relation to birth outcomes in Zimbabwe, and assessment of the burden of child injury in Ethiopia.

Finally, HRCI has focused heavily on capacity building in target countries. Over the course of the HRCI agreement, researchers from JHSPH and MUHAS supported the Tanzanian Ministry of Health and Social Welfare and its Task Force on Community Health Workers (CHWs) in their efforts to develop a national cadre of CHWs that will best serve the needs of people in the Tanzania. Another project, ‘Best Practices, Capacity-Building and Leadership for Maternal, Neonatal and Child Health, Family Planning and Nutrition Programs in Bangladesh,’ focused on building capacity for public health leadership and promoting local best practices.

This final report presents an abbreviated description of each of the funded studies/activities under the HRCI, highlighting findings and implications for policy and program implementation. It is organized by study country/region plus other global activities studies and other administrative and technical support. In addition to the main text, Appendix A includes a list of publications and manuscripts in various stages of preparation, organized by study.

RESEARCH IN ASIA

The work of the HRCI built on the large portfolio of research undertaken in Bangladesh under the Global Research Activity (GRA) CA which included five main randomized controlled trials (Projahnmo-1, Projahmo-2, Chlorhexidine Cleansing, Simplified Antibiotic Treatment, and Thermal Care) along with their accompanying efforts (i.e. maternal interventions sub-study in Projahnmo-1, formative research on Chlorhexidine, Chlorhexidine Operations Research (OR), and Sepsis OR proposal development). Dissemination and write-up of several studies was completed during the life of HRCI. The Simplified Antibiotic Treatment trial which began under GRA was completed in 2014 and led into an implementation research study to support Bangladesh MOHFW to implement its recent policy of management of clinically suspected serious infections (CSSI). Additional efforts were undertaken to support the Bangladesh health sector and develop in-country research and leadership capacity. Outside of Bangladesh, the Repeat Reproductive Age Mortality Study (RAMOS II) was completed in Afghanistan and research on community-oriented approaches to improve recognition of and appropriate care seeking for newborn and/or maternal complications was undertaken in Nepal as part of a larger study led by TRAction.

Determining the Burden of Maternal Ill Health and Death and its Programmatic Implications in Rural Bangladesh Dissemination

Study Overview:

The study entitled “Determining the burden of maternal ill health and death and its programmatic implications in rural Bangladesh” was funded under USAID’s GRA CA from May 2006 to September 2009. The study was implemented in Matlab, Bangladesh, using both quantitative and qualitative research methods, to investigate the following:

•Women who suffer severe obstetric complications are at risk of suffering from further physical, social, mental consequences or death compared to those with normal deliveries with no complication.

•Women who suffer from poor pregnancy outcomes (e.g., stillbirths, early neonatal death) are at risk of suffering from further physical, social, mental consequences or death compared to those with normal deliveries with no complication.

•A child of a mother suffering from severe maternal complications is at higher risk of death, poorer growth and development than those of women without such consequences.

•Families of women who have suffered severe maternal complications (and/or poor pregnancy outcomes) are at higher risk of dissolution, violence, and/or impoverishment.

The dissemination event occurred after the close of the GRA CA on November 11 and 12, 2009 and was funded by HRCI. On November 11, 2009 a working group meeting with selected experts from the government, NGO and private sectors gathered to share the study findings and set policy recommendations. On the following day the results were disseminated among the wider audience (about 100 participants) including policy makers, program managers, researchers and professionals. It was decided that the recommendations from the study will be further discussed among the group of maternal health experts and policy makers for consideration for policy formulations. The study resulted in a number of peer reviewed publications, including a special journal issue “Maternal Morbidity, Disability and their consequences: Neglected Agenda in Maternal Health” in the Journal of Health, Population and Nutrition.

Partners:

ICDDR,B

Main Findings and Implications:

  • The prospective study was conducted to assess the effect of severe obstetric morbidities on short-term physical, psychological, and economic consequences on the life of women, their children and other family members and also the effect of mothers’ severe obstetric complications on child development. Based on the findings, the study recommends:
  • Facility delivery to ensure good outcomes for both mother and newborn at delivery and beyond. There is also suggestion to improve the quality of intrapartum care in both public and private facilities. To monitor quality of care in facilities, a uniform standardized record keeping system is also required amongst both public and private facilities.
  • Testing different counseling models for families and communities where there is a perinatal death to lessen depression, blame and emotional violence.
  • That financial protection is needed for the poorest to encourage use of facilities for delivery and prevent families being impoverished. It also suggests that demand side financing should be expanded conditional on evaluation. For long-term there should be more policy options.
  • That programs addressing pre-pregnancy and antenatal counseling on early childhood development should be given priority.
  • The retrospective study was conducted using the Health and Demographic surveillance System (HDSS) and the other safe motherhood data sources in Matlab (during 1882 and 2005) to assess the effect of maternal death on survival and education of children.
  • The study finds that infant mortality is about eight times higher in the case of a maternal death. It also confirms if a mother dies in the first five years of life, eight of ten children under five years of age are likely to die. Children who lose their mother are also likely to have less education as compared to their counterpart. This finding has strong advocacy message that mother’s death carries double burden.
  • Qualitative studies were also conducted to understand the short- and long-term social consequences of maternal morbidities.
  • People in rural Matlab often failed to understand the severity of short- and long-term pregnancy-related morbidities and did not k now where to seek care for their problems. As a result, their health problems were often overlooked and remained untreated, frequently leading to severe social consequences for women. To avoid pregnancy-related morbidities proper referral mechanisms with functional emergency obstetric and gynecological care need to be made accessible to rural communities. Awareness raising campaigns should be developed to disseminate information on potential complications during and after delivery, and the importance of obtaining timely treatment for physical and psychological consequences associated with these conditions. Doctors and health workers should be accountable to the community in terms of explaining the reasons for doing a c-section and the potential consequences.

Chlorhexidine (CHX) Main Trial Dissemination

Study Overview:

Three large CHX trials were conducted in Bangladesh, Nepal and Pakistan. Two of them, in Bangladesh and Nepal, were conducted by Johns HopkinsDepartment of International Health. Two of these trials were funded by USAID and the other one was funded by NIH. After these trials were completed, USAID/HRCI supported a joint analysis of all investigators from all three sites in Baltimore and a pooled analysis was done showing a 23% reduction in neonatal mortality. HRCI also fundeddissemination efforts with other partners, including a dissemination meeting, Chlorhexidine for Umbilical Cord Care: Evidence Base and the Way Forward Dissemination Workshopthat was held in Nepalgunj, Nepal on September 15-16, 2011.

Partners:

PATH

Saving Newborn Lives – Save the Children

MCHIP

Main Findings and Implications:

  • Results of all three trials were presented at the dissemination workshop in Nepal in 2011. Over 70 participants attended, including representatives from governments and NGOs from over 7 countries.
  • The overall results of the meeting demonstrated that there is sufficient evidence to recommend inclusion of 4% chlorhexidine cord cleansing as a strategy to reduce neonatal mortality in settings where poor hygiene and high neonatal mortality are issues.
  • Applying 4% CHX immediately after cord cutting proved most effective in reducing neonatal mortality and omphalitis.
  • The reduction of neonatal mortality in the three countries varied from 20% to 38%.
  • The demonstrated reduction in omphalitis ranged from 24% to 75%.
  • Based on these trial results, in 2012, WHO revised its umbilical cord care recommendation for high mortality settings. The new guideline recommends that newborn umbilical cord should be cleansed with CHX
  • To support scale up of CHX umbilical cord care, a global Chlorhexidine Working Group was established. The Working Group has worked with ministries of health, manufacturers, and regulatory authorities in Sub-Saharan Africa and South Asia to select appropriate supply strategies to ensure sustainable availability of quality chlorhexidine for umbilical cord care.
  • The working group also supported ministries of health and other key stakeholders in priority countries to develop country-driven policies, clinical guidelines as well as program designs for sustainable introduction and scale up of the chlorhexidine product in newborn care programs.
  • Now, over 25 countries are exploring or implementing chlorhexidine for umbilical cord care. Of these, ten countries are engaged in scale up and another nine are piloting use of the product or aligning policy for product introduction
  • Introduction/scale up: DRC, Ethiopia, Kenya, Liberia, Madagascar, Malawi, Mozambique, Nepal, Nigeria and Pakistan.
  • Pilot/Policy alignment: Afghanistan, Bangladesh, Ghana, Haiti, India, Mali, Niger, Uganda and Zambia
  • Expressed interest: Angola, Benin, Burkina Faso, Cameroon, Cote d’Ivoire, Myanmar, Senegal, Sierra Leone

Analysis of Outcomes Related to Short Inter-Pregnancy Intervals (IPI) in Projahnmo I and II (Sylhet and Mirzapur)

Study Overview:

This study was a secondary data analysis of studies conducted in Bangladesh by the Projahnmo Study Group which is a research partnership of Johns Hopkins University with Bangladeshi institutions. The data were drawn from a study known as ‘Projahnmo I’ which was a community-based, cluster randomized trial that was conducted in the Sylhet district of Bangladesh. The aim of the original study was to evaluate the effect of an integrated maternal and newborn care program on neonatal mortality. The trial had 3 arms including a comparison area with usual care; a home-based care arm where trained community health workers (CHWs) made home visits to provide counselling during pregnancy and the immediate post-partum period; and a community care arm where health promotion was conducted through group sessions. Each arm was made up of 8 clusters of population sizes around 20,000. In the analysis of the parent trial, we used data from the endline survey conducted in 2006 to determine whether interventions resulted in changes in neonatal mortality rates and maternal and newborn care practices. These data were also used for the present study.

The secondary analysis of this data set was conducted to examine the association of birth interval with birth outcomes using pregnancy histories and outcome data that occurred between 2003 and 2005 among married women aged 15-49 years in Sylhet, Bangladesh. The data included 49,544 pregnancy outcomes from 36,560 mothers. Reported adverse pregnancy outcomes were spontaneous abortion, stillbirth and neonatal death. Logistic regression models with robust standard errors were applied to account for within-mother clustering of outcomes and adjusted for previous pregnancy outcomes, child- and mother-level factors, and household socioeconomic status (SES) derived from household-level socio-economic variables.