Letters of Intent – Implementation Research on Administration of Antenatal Corticosteroids during Intrapartum

REQUEST FOR LETTERS OF INTENT: PAKISTAN

Jointly issued by World Health Organization and the Ministry of National Health Services, Regulations and Coordination, Government of Pakistan

Deadline for Submission of Letters of Intent: 2 weeks after release of this request of LOI

OVERVIEW

World Health Organization and the Ministry of National Health Services, Regulations and Coordination (MoNHSR&C) propose to support a high-quality implementation research study in Pakistan to generate the evidence, experience and momentum for scale up of safe use of antenatal corticosteroids (ACS) during intrapartum care. This implementation research will focus on how to overcome key barriers for administrating ACS as per the WHO criteria at scale. The implementation approach will be formulated on the basis of in-depth formative research, and this approach will be used to develop and concurrently evaluate an optimized implementation model that will achieve at least 70% population-level coverage of use of safe antenatal corticosteroids (ACS) (according to WHO criteria for use) in women having an early preterm birth (less than 34 weeks). This optimal implementation model for safe ACS will be used at scale (in six health administrative areas) to measure the impact of such implementation on neonatal mortality.

The study will be conducted in two phases:

Phase 1:  Develop and concurrently evaluate an optimized implementation model in LMICs that will achieve at least 70% population-level coverage of use of safe antenatal corticosteroids (ACS) (according to WHO criteria for use) in women having an early preterm birth (less than 34 weeks)

Phase 2: To evaluate this optimal model for safe ACS at scale (in six health administrative areas) in a stepped-wedge cluster randomized controlled design to measure the impact of such implementation on neonatal mortality

The lessons learned and experiences of all sites will be used to develop or refine national strategy for scale up of safe ACS use. At the end of the project the research institution is expected to become a Technical Support Unit to support scale up of safe ACS use in the country, in partnership with obstetrics and paediatrics professional associations.

BACKGROUND

Preterm birth is a leading cause of under-5 mortality globally. Antenatal corticosteroids (ACS) remain the main intervention for reducing the adverse effects of preterm birth. The effectiveness of ACS in low-resource settings was questioned by the publication of findings of the Antenatal Corticosteroids Trial (ACT) which did not show any benefit of ACS in small babies but showed an overall increase in neonatal mortality. The recently completed WHO-supported ACTION-I trial used appropriate criteria for ACS use and has clearly shown a substantial impact of the intervention on neonatal mortality.  This trial provides much-needed evidence not only on the beneficial effects of ACS in reducing neonatal mortality in low-resource settings, but also insights into potentially beneficial components of implementation strategies to safely scale up ACS in these settings. Key lessons from ACTION-I trial were that, in order to achieve clinical benefits from ACS, 1) pregnant women need to have ultrasound gestational age (GA) dating and 2) a high likelihood of preterm birth, and 3) preterm infants should be cared for in facilities that can provide minimum package of neonatal care.

While coverage of ACS is high (>90%) in high-income countries, it remains low (~40%) in many LMICs. We need to learn how to implement the ACTION trial findings for ACS use in routine health systems in low-resource settings and achieve a high coverage of appropriate ACS use. To re-establish confidence in the potential impact of ACS in reducing the high burden of neonatal mortality in low-resource countries, it is crucial to demonstrate that increased ACS coverage in early preterm birth (i.e. the population where ACS has been shown to confer health benefits) is associated with reduced neonatal mortality rate in real-life, programmatic settings.

CHARACTERISTICS OF RESEARCH PROJECTS TO BE DEVELOPED

The research grantees will be asked to propose how they will achieve the outcomes of this initiative.  However, we anticipate the following activities to be part of the most successful proposals.

       Undertake formative research on ACS administration to identify barriers to uptake of ACS in the specific local context. Formative research over 3 months timeframe will include facilities and communities and key populations such as health care providers, community leaders, families, and the mother-infant dyad. A key part of this effort is user-centric design focused on the needs, motivations, and influencers of the mother-infant dyad.  Formative research will include both supply issues (through the health system and providers) and demand issues (primarily through the mother and family). Subsequently the formative research team will function as the program learning team to improve the model and its implementation

     Phase 1 (2.5 years): Each study team will design one or more scalable models for ACS administration based on formative research and user-centric design. This will include ACS guidelines, protocols, communication materials, training materials, and tools needed for implementing the delivery model in facilities and in the community. ACS delivery models will be designed such that they could be effectively scaled-up through the existing health system, taking into account system barriers and constraints identified in formative research. 

Grantees will also finalize the geographic scope of their implementation at this stage; the geographic scope should be sufficient to provide proof of concept of deliverability at scale. The first phase will be in one administrative area with 1-2 ACS implementing facilities and many in the network of facilities to help develop the model besides the interventions at community level such as early registration, early dating scans etc in the catchment areas of the facilities involved.

       Phase 2 (2.5 years): Each study team will evaluate the impact of the scale up of the optimized model, on coverage, safety and impact outcomes in a stepped-wedge cluster randomized controlled trial in 6 administrative clusters with a network of health facilities. Women at high risk of preterm birth between 26- less than 34 weeks gestation will be the target of the ACS package and, together with their babies, will also be subjects for outcome assessment. Health providers will be the target of facility and provider level components of the implementation model. The impact on neonatal mortality rate, ACS coverage and safety outcomes (proportion of women who received ACS and delivered at term and maternal infection) will be evaluated.

       The research studies will be implemented in full partnership with the MoNHSR&C and provincial Departments of Health, including at the provincial and district levels. Implementation activities will include guideline dissemination; health care provider training (including community health care workers if part of the model); early registration of pregnancy; early dating scans; identification of  pregnant women at risk of preterm delivery; care seeking at appropriate health facilities; demand generation/communication; community mobilization; incentive structures for health care providers, mothers, and families; establishing referral and supervision systems; monitoring; and continuous feedback loops and adaptation.  Grantees will work closely with the provincial Departments of Health or other institutions that are accountable for service delivery to pilot the delivery model(s).  Grantees will be responsible for the evaluation component.

       Collaborate with fellow grantees to coordinate evaluation methodologies, to share information, and to disseminate results from this initiative. 

       Applied implementation research methods will be included as part of applications.  Mixed methods (qualitative/ quantitative) will be required to understand what is working and why different components of the model work or do not work. Cluster RCT in a stepped-wedge design is part of Phase 2 of this implementation research.

       ACS package must be implemented as an integral aspect of maternal and child health programs and other effective interventions should be linked. ACS package must be implemented within the existing health service delivery and not as a vertical program.

ELIGIBILITY CRITERIA

Institutions in Pakistan are eligible to apply to this call if they meet the following criteria:

       Team lead to have medical graduation with post graduate degree in public health, epidemiology, Gyne/Obstetrics, peadiartics/neonatology or relevant field with more than 10 years’ experience in clinical and research areas

       A multidisciplinary research team (with lead researcher having experience of at least 10 years), in two aspects: (1) mix of technical expertise (e.g. maternal and newborn health, social sciences, epidemiology etc.) relevant to the proposed study and (2) mix of roles and responsibilities within the health system (e.g. researchers, policy-makers, programme managers, etc.)

       Implementation research experience in learning how to scale up maternal and/or newborn health interventions.

Experience in improving newborn health services in district or subdistrict level facilities will be valuable.

       Each research team must include at least one decision-maker form the provincial Department of Health.

SUBMISSION PROCESS

WHO will serve as the Secretariat for this call and the development of research projects. The deadline for submission of letters of intent with support letter from each region is thetwo weeks after the release of the call.  Letters of intent of no more than 4 pages must be submitted by email to WHO (bahlr@who.int; oladapoo@who.int; gholbzourik@who.int; thome@who.int). All letters of intent must be written in English. Letters received after the deadline will not be reviewed and scored. One organization can only submit one letter of intent to implement the research in one province only.

The letters of intent should include the following:

·        Objectives and methodological approach

·        Study site description

·        Study implementation strategy

·        Study teams and responsibilities

·        Institutional capacity

·        Budget outline (not to exceed 2 million US dollars for the 5-year study)

·        One page CV for up to 3 investigators (additional to the 4 page letter of intent)

SELECTION PROCESS

All letters of intent will be reviewed on a competitive basis by a steering group consisting of WHO and MoNHSR&C staff. Scoring will be done by a panel of external experts according to merit and relevance to the Call. The proposals will be assessed on the following criteria:

Feasibility of conducting the study in the proposed site.

Appropriateness and robustness of proposed implementation strategy.

Capacity of the research team to implement the proposal.

Engagement of the Ministry of NHSR&C and respective provincial Department(s) of Health.

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