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PSBI: Overall Goal is to see high, quality coverage of PSBI treatment in…

- - - - Ministry of Health committed to secure funding for procurement and need-based distribution of these drugs and commodities
      - Maternal Child Health Directorate working with other directorates to ensure that key iCCM/CBNC indicators are included in the HMIS
      - Maternal Child Health Directorate will develop a Reproductive Maternal Newborn Child Health scorecard at Zonal and Woreda levels and will ensure that iCCM/CBNC/IMNCI targets are included in the annual Woreda Health Plan
    - - Aimed at increasing the uptake of iCCM/CBNC services in Ethiopia
        
        Important lessons learned include strategies such as engaging agriculture extension workers to reach male partners, engaging schools, using social and behavioral change tools for low literate audiences
      - focuses on demand creation for iCCM/CBNC
    - - Intervention includes 5-day Gentamicin injection and 7-day Amoxicillin oral tablet for PSBI.
    - - Results will help inform emerging national plan to improve coverage of high quality iCCM/CBNC and research teams on regional and national Technical Working Groups will facilitate this process
        
        Critical for team to harness commitment and support for iCCM/CNBC and QI to mobilize same level of commitment and support at regional, zonal, and woreda levels.
  - - - Facilitate and confirm engagement of the Federal Ministry of Health and Regional Health Bureau authorities in the study.
      - Ethics approval from the Regional Health Bureaus Ethics Committees and from each academic partner IRB
      - Identifying and procuring office space where needed, staffing, obtaining equipment and supplies, launching the study, orienting facility stakeholders and communities to the study, research team building and training, development and standardization of data collection tools, and site selection
        
        In selecting sites, the criteria are need (i.e. high PSBI prevalence), range of accessibility, functionality of facilities, relevance to providing newborn care, and sample size requirements
        
        Study population includes all babies 0-28 days of life with signs of PSBI born in target catchment areas who are seen in health posts for outpatient PSBI treatment. Exclusion criteria are babies 29 days or older, or who die before treatment can be initiated
    - - Formative research to identify facilitators and barriers to implementing the simplified PSBI treatment protocol in local context
      - Design one or two user-centric scalable model(s) that work across the facility-community continuum to increase effective coverage of the simplified PSBI treatment protocol
        
        Test model, analyze factors associated with implementation successes and failures, and redesign or refine model
        
        Expect three, 3-4 month cycles of this process. Representative group of stakeholders will review finding and provide inputs. Final cycle will be chosen for evaluation
    - - Primary Outcome Measure: Success is defined as 80% or higher coverage of effective simplified PSBI treatment at population level
        
        This stretch goal desired within 3 years of implementation!
      - Secondary Outcome Measures: (1) facility effective coverage of the protocol; (2) percent of eligible babies referred to a facility for sepsis treatment with the protocol; (3) percent of eligible babies who received intramuscular gentamicin per protocol; (4) percent of eligible babies who received oral amoxicillin per protocol; (5) treatment failure (i.e., no clinical improvement, deterioration and/or death on or before day 8 after initiation)
      - Newborns who meet PSBI inclusion criteria will be identified and enrolled until require sample size is reached. n=317; Study sites that have a sufficient number of eligible babies will be selected
    - - Stakeholder review of Phase 2 results, developed of costed plans for scale-up covering a wider geographic area in the country ( national or regional context), packaging of the study findings and materials, dissemination and advocacy
  - - - Guidelines center around protective function for newborns in pregnancy, labor, and post-partum periods
        
        Pregnancy functions include early pregnancy identification, focused antenatal care and promotion of institutional delivery
        
        Labor function include asphyxia recognition, initial stimulation-resuscitation, and hypothermia management
        
        Community Postpartum functions include pre-term/low birth weight management, neonatal sepsis management, and severe disease management. HEW are expected to identify signs of PSBI, initiate antibiotic treatment early, provide medication adherence counseling, and encourage post-treatment clinical follow-up
      - Due to heavy HEW workloads, HEW tasks may be shifted to the HDA. This includes tasks such as community mobilization pregnancy identification, educating mothers and families on birth preparedness and complication readiness, maternal and newborn danger sign recognition, labor birth notification, and early postnatal care
        
        Will allow HEWs to keep health posts open and functioning to better address newborn health problems. This also is in line with government's new directive to keep health posts open at all times.
      - HEWs and HDA play pivotal role for creating demand for preventative and curative health services, including CBNC and PSBI treatment. See section below on demand creation for more
        
        The study will strengthen the HEP platform and iCCM/CBNC by enhancing HEW and HDA capacity to fulfill roles in PSBI identification, treatment and follow-up
      - Implementation Support Team
        
        Assist HEWs and HDA leaders to leverage existing networks of influence in their kebeles through Command Posts and Administration to build awareness and support for PSBI treatment
        
        Provide support for cultural norm creation through media-based messages on early PSBI identification
        
        Provide knowledge transfer, which includes info on PSBI prevention and availability of treatment
        
        Provide health system improvement via CQI to identify, test, and evaluate local solutions to anticipated barriers in PSBI uptake
        
        This includes system-barriers to PSBI care, such as HEW and HDA capacity to identify PSBI, optimizing referral systems between communities and facilities, and expanding facility's human capital for PSBI treatment, HEW retention, supply chain bottlenecks
        
        Includes cultural and logistical barriers to care seeking, such as illness recognition, beliefs about place of birth and care of the sick newborn, outcome expectations, postpartum confinement, availability and cost of transportation to facilities, low awareness of PSBI risks and treatment availability. (Refer to demand creation)
    - - Champions committed to identify areas for improvement from supply side and demand side
- - - - National policymakers are supportive of simplified treatment of PSBI in outpatient settings
      - Steering Committee, which includes representatives from resource groups, policy makers, potential adopters and implementers, and from the target population work to advocate and ensure that a national policy and protocol for simplified PSBI treatment are adopted and implemented. This includes stakeholders from USAID, Save the Children, WHO, UNICEF, Federal Ministry of Health, MCSP, regional health bureaus, hospital and health center heads, and university PIs
- - - - Steering committee reviews and advises on model development, implementation and evaluation, advises on presentation of results, participates in scale-up planning, advocate for and position the best model of PSBI service delivery for scale-up. The committee will also provide the coordinated leadership so evidence of impact, feasibility, and cost benefit of the model is applied quickly.
    - - Program Learning research team enrolls eligible babies admitted into the study, observe PSBI treatment activities in implementing facilities and communities, help formulate the initial intervention model based on the findings of observation and formative research, and conduct program learning and process monitoring.
        
        Works closely with Implementation Support team for adaptation and improvement of the intervention model
      - Outcome Measurement Research team will establish a system for electronic data capture for births and PSBI surveillance, primary and secondary outcome measurement, process monitoring, observations at facilities and homes, and costing and quality assurance. This team will also measure primary and secondary outcomes independently of health worker documentation as well as examine relevant costs.
        
        It will provide regular feedback on outcomes to the Program Learning Research Team and Implementation Support Research team.
        
        Outcome Measurement team will work closely with health personnel and Program Learning Research Team to ensure appropriate identification, enrollment, and consent into the study
  - - - Implementation Support research team works with these personnel to create an environment that is conducive to PSBI care and ensure that providers implement the simplified PSBI treatment protocol with fidelity. This research team also will provide staff technical updates in newborn sepsis management, supervisor CQI training and coaching.
- - - - These individuals will become champions of new treatment protocol and work to create centers of excellence for PSBI treatment in outpatient facilities
  - - - Raise community awareness on health posts treatment and services for sick newborns
      - Address existing cultural barriers to newborn care seeking within communities, such as fear of exposing newborn to harm if they leave home or beliefs that newborns are "too small" to take medicine or be treated at health facilities
  - - - Desired sample size will be adjusted to account for this refusal. Contingency plans will be in place. One option is to enlist the support of additional health facilities so that additional participants can be recruited each month. Another is to extend the data collection period to the extent possible. A last resort is to modify the analysis plan.
      - PSBI surveillance and case detection, admission to the selected implementing health facilities,and ease of recruitment will be monitored closely during study Phases 1-2 so that any indication that sample size may not be achieved can be addressed early on
    - - Measures to limit these, such as formative research interviews outside the clinical setting should allow participants to report answers truthfully
    - - Political instability could have impact on ability of individual sites to recruit, enroll, or follow-up participants. However, Ethiopia is politically stable at this time
      - The proposed study areas are not particularly high risk of natural disasters, with the exception of drought and associated population displacement. The study will factor risk of drought into specific site selection
    - - Regulatory approval in each of the sites could be delayed and influence the success of the project in keeping to the proposed timeline
      - We will engage all stakeholders in discussions and have no reason to doubt that we will be successful in ensuring their collaboration