Scaling up context-tailored clinical guidelines and training to improve childbirth care in urban, low-resource maternity units in Tanzania: A protocol for a stepped-wedged cluster randomized trial with embedded qualitative and economic analyses (The PartoMa Scale-Up Study).

While facility births are increasing in many low-resource settings, quality of care often does not follow suit; maternal and perinatal mortality and morbidity remain unacceptably high. Therefore, realistic, context-tailored clinical support is crucially needed to assist birth attendants in resource-constrained realities to provide best possible evidence-based and respectful care. Our pilot study in Zanzibar suggested that co-created clinical practice guidelines (CPGs) and low-dose, high-frequency training (PartoMa intervention) were associated with improved childbirth care and survival. We now aim to modify, implement, and evaluate this multi-faceted intervention in five high-volume, urban maternity units in Dar es Salaam, Tanzania (approximately 60,000 births annually). This PartoMa Scale-up Study will include four main steps: I. Mixed-methods situational analysis exploring factors affecting care; II. Co-created contextual modifications to the pilot CPGs and training, based on step I; III. Implementation and evaluation of the modified intervention; IV. Development of a framework for co-creation of context-specific CPGs and training, of relevance in comparable fields. The implementation and evaluation design is a theory-based, stepped-wedged cluster-randomised trial with embedded qualitative and economic assessments. Women in active labour and their offspring will be followed until discharge to assess provided and experienced care, intra-hospital perinatal deaths, Apgar scores, and caesarean sections that could potentially be avoided. Birth attendants' perceptions, intervention use and possible associated learning will be analysed. Moreover, as further detailed in the accompanying article, a qualitative in-depth investigation will explore behavioural, biomedical, and structural elements that might interact with non-linear and multiplying effects to shape health providers' clinical practices. Finally, the incremental cost-effectiveness of co-creating and implementing the PartoMa intervention is calculated. Such real-world scale-up of context-tailored CPGs and training within an existing health system may enable a comprehensive understanding of how impact is achieved or not, and how it may be translated between contexts and sustained.Trial registration number: NCT04685668.

Scaling up Locally Adapted Clinical Practice Guidelines for Improving Childbirth Care in Tanzania: A Protocol for Programme Theory and Qualitative Methods of the PartoMa Scale-up Study.

Effective, low-cost clinical interventions to improve facility-based care during childbirth are critical to reduce maternal and perinatal mortality and morbidity in low-resource settings. While health interventions for low- and lower-middle-income countries are often developed and implemented top-down, needs and circumstances vary greatly across locations. Our pilot study in Zanzibar improved care through locally co-created intrapartum clinical practice guidelines (CPGs) and associated training (the PartoMa intervention). This intervention was context-tailored with health-care providers in Zanzibar and now scaled up within five maternity units in Dar es Salaam, Tanzania. This PartoMa Scale-up Study thereby provides an opportunity to explore the co-creation process and modification of the intervention in another context and how scale-up might be successfully achieved. The overall protocol is presented in a separate paper. The aim of the present paper is to account for the Scale-up Study's programme theory and qualitative methodology. We introduce social practice theory and argue for its value within the programme theory and towards qualitative explorations of shifts in clinical practice. The theory recognizes that the practice we aim to strengthen - safe and respectful clinical childbirth care - is not practiced in a vacuum but embedded within a socio-material context and intertwined with other practices. Methodologically, the project draws on ethnographic and participatory methodologies to explore current childbirth care practices. In line with our programme theory, explorations will focus on meanings of childbirth care, material tools and competencies that are being drawn upon, birth attendants' motivations and relational contexts, as well as other everyday practices of childbirth care. Insights generated from this study will not only elucidate active ingredients that make the PartoMa intervention feasible (or not) but develop the knowledge foundation for scaling-up and replicability of future interventions based on the principles of co-creation and contextualisation.

Factors Influencing the Sustainability of Neglected Tropical Disease Elimination Programs: A Multi-Case Study of the Kenya National Program for Elimination of Lymphatic Filariasis.

Elimination of a disease is the holy grail in global health. The pathology of several neglected tropical diseases (NTDs) such as lymphatic filariasis (LF) makes elimination a reality. However, successful elimination requires that NTD programs be sustainable-the ability to confirm that the disease has been eliminated and the capacity to ensure that it does not return. The WHO's guidelines on NTDs thoroughly detail how to reach elimination. Notwithstanding, comprehensive guidance regarding contextual and programmatic factors that influence sustainability is lacking. Moreover, a comprehensive NTD sustainability framework that includes these factors is nonexistent. This research aimed to develop a framework that identified the critical programmatic and contextual factors influencing sustainability of NTD elimination programs. The methodology included a literature review and a multiple case study. The literature review had two objectives: the first was to identify unique attributes of NTD elimination programs that should be considered when planning for sustainability and the second was to identify an existing sustainability framework that could be adapted to NTD elimination programs. The literature review resulted in a draft sustainability framework that was then tested, using a multi-case study methodology, on the Kenya National Program for Elimination of Lymphatic Filariasis. The result is the first comprehensive NTD sustainability framework that identifies key contextual and programmatic factors that influence NTD sustainability. This framework is an invaluable resource for practitioners and policy makers alike as many countries start to eliminate NTDs.

The Risk of Tuberculosis among Populations Living in Slum Settings: a Systematic Review and Meta-analysis.

According to the WHO, half of the 10.4 million incident cases of TB in 2016 came from five countries where 20-50% of the urban population live in slums. Crowded living conditions and limited access to healthcare further contribute to the burden of TB in urban slums. This article aims to assess the odds of the burden of TB in urban slums through a systematic review and meta-analysis. Four electronic databases were searched for studies published between 1993 and 2017, with TB defined as at least one sputum smear-positive. The review followed the PRISMA protocol and information was extracted from articles for a full-text review to determine eligibility. Odds ratios were calculated for studies reporting sputum smear-positive TB cases in slum settings with national incidence as a comparison. Summary estimates were calculated using the random effects model (95% CI) and publication bias was assessed through funnel plot analysis. A quality assessment of included articles was also conducted. This meta-analysis was conducted across three categories: (1) across all 22 studies, (2) studies utilizing Active Case Finding, and (3) studies conducted in a high TB-HIV setting. The odds of sputum smear-positive TB were significantly higher across all three categories of analysis. Compared with national TB incidence rates, the combined odds ratio of smear-positive TB within slums was 2.96 (2.84, 3.09; p < 0.01). The combined odds ratio for smear-positive TB with active case finding across 15 studies was 2.85 (2.71, 2.99; p < 0.01). Among the 11 studies that reported incidence of smear-positive TB with prevalent TB-HIV coinfection in the community, the combined odds ratio for slum residents with the random effects model was 2.48 (2.34, 2.63; p < 0.01). Using Egger's funnel plot, publication bias was not detected within the three categories of analysis. The findings of this analysis indicate that the odds of developing TB are almost five times as great in urban slums. Reaching the most vulnerable and often overlooked groups in slums is crucial to achieving the SDGs and End TB Strategy by 2035.

Unmet Need: Improving mHealth Evaluation Rigor to Build the Evidence Base.

mHealth-the use of mobile technologies for health-is a growing element of health system activity globally, but evaluation of those activities remains quite scant, and remains an important knowledge gap for advancing mHealth activities. In 2010, the World Health Organization and Columbia University implemented a small-scale survey to generate preliminary data on evaluation activities used by mHealth initiatives. The authors describe self-reported data from 69 projects in 29 countries. The majority (74%) reported some sort of evaluation activity, primarily nonexperimental in design (62%). The authors developed a 6-point scale of evaluation rigor comprising information on use of comparison groups, sample size calculation, data collection timing, and randomization. The mean score was low (2.4); half (47%) were conducting evaluations with a minimum threshold (4+) of rigor, indicating use of a comparison group, while less than 20% had randomized the mHealth intervention. The authors were unable to assess whether the rigor score was appropriate for the type of mHealth activity being evaluated. What was clear was that although most data came from mHealth projects pilots aimed for scale-up, few had designed evaluations that would support crucial decisions on whether to scale up and how. Whether the mHealth activity is a strategy to improve health or a tool for achieving intermediate outcomes that should lead to better health, mHealth evaluations must be improved to generate robust evidence for cost-effectiveness assessment and to allow for accurate identification of the contribution of mHealth initiatives to health systems strengthening and the impact on actual health outcomes.

How Can We Better Evaluate Complex Global Health Initiatives? Reflections From the January 2014 Institute of Medicine Workshop.

An IOM workshop on evaluation design drew on recent evaluations of 4 complex initiatives (PEPFAR; the Global Fund to Fight AIDS, TB and Malaria; the President's Malaria Initiative; and the Affordable Medicines Facility-malaria). Key components for good evaluations: (1) a robust theory of change to understand how and why programs should work; (2) use of multiple analytic methods; and (3) triangulation of evidence to validate and deepen understanding of results as well as synthesis of findings to identify lessons for scale-up or broader application.

Tracking Global Fund HIV/AIDS resources used for sexual and reproductive health service integration: case study from Ethiopia.

OBJECTIVE/BACKGROUND: The Global Fund to Fight AIDS, Tuberculosis & Malaria (GF) strives for high value for money, encouraging countries to integrate synergistic services and systems strengthening to maximize investments. The GF needs to show how, and how much, its grants support more than just HIV/AIDS, TB and malaria. Sexual and Reproductive Health (SRH) has been part of HIV/AIDS grants since 2007. Previous studies showed the GF PBF system does not allow resource tracking for SRH integration within HIV/AIDS grants. We present findings from a resource tracking case study using primary data collected at country level. METHODS: Ethiopia was the study site. We reviewed data from four HIV/AIDS grants from January 2009-June 2011 and categorized SDAs and activities as directly, indirectly, or not related to SRH integration. Data included: GF PBF data; financial, performance, in-depth interview and facility observation data from Ethiopia. RESULTS: All HIV/AIDS grants in Ethiopia support SRH integration activities (12-100%). Using activities within SDAs, expenditures directly supporting SRH integration increased from 25% to 66% for the largest HIV/AIDS grant, and from 21% to 34% for the smaller PMTCT-focused grant. Using SDAs to categorize expenditures underestimated direct investments in SRH integration; activity-based categorization is more accurate. The important finding is that primary data collection could not resolve the limitations in using GF GPR data for resource tracking. The remedy is to require existing activity-based budgets and expenditure reports as part of PBF reporting requirements, and make them available in the grant portfolio database. The GF should do this quickly, as it is a serious shortfall in the GF guiding principle of transparency. CONCLUSIONS: Showing high value for money is important for maximizing impact and replenishments. The Global Fund should routinely track HIV/AIDs grant expenditures to disease control, service integration, and overall health systems strengthening. The current PBF system will not allow this. Real-time expenditure analysis could be achieved by integrating existing activity-based financial data into the routine PBF system. The GF's New Funding Model and the 2012-2016 strategy present good opportunities for over-hauling the PBF system to improve transparency and allow the GF to monitor and maximize value for money.

Drivers of routine immunization coverage improvement in Africa: findings from district-level case studies.

There is limited understanding of why routine immunization (RI) coverage improves in some settings in Africa and not in others. Using a grounded theory approach, we conducted in-depth case studies to understand pathways to coverage improvement by comparing immunization programme experience in 12 districts in three countries (Ethiopia, Cameroon and Ghana). Drawing on positive deviance or assets model techniques we compared the experience of districts where diphtheria-tetanus-pertussis (DTP3)/pentavalent3 (Penta3) coverage improved with districts where DTP3/Penta3 coverage remained unchanged (or steady) over the same period, focusing on basic readiness to deliver immunization services and drivers of coverage improvement. The results informed a model for immunization coverage improvement that emphasizes the dynamics of immunization systems at district level. In all districts, whether improving or steady, we found that a set of basic RI system resources were in place from 2006 to 2010 and did not observe major differences in infrastructure. We found that the differences in coverage trends were due to factors other than basic RI system capacity or service readiness. We identified six common drivers of RI coverage performance improvement-four direct drivers and two enabling drivers-that were present in well-performing districts and weaker or absent in steady coverage districts, and map the pathways from driver to improved supply, demand and coverage. Findings emphasize the critical role of implementation strategies and the need for locally skilled managers that are capable of tailoring strategies to specific settings and community needs. The case studies are unique in their focus on the positive drivers of change and the identification of pathways to coverage improvement, an approach that should be considered in future studies and routine assessments of district-level immunization system performance.

Hospital ships adrift? Part 2: the role of US Navy hospital ship humanitarian assistance missions in building partnerships.

INTRODUCTION: US Navy hospital ships are used as a foreign policy instrument to achieve various objectives that include building partnerships. Despite substantial resource investment by the Department of Defense (DoD) in these missions, their impact is unclear. The purpose of this study was to understand how and why hospital ship missions influence partnerships among the different participants. METHODS: An embedded case study was used and included the hospital ship Mercy's mission to Timor-Leste in 2008 and 2010 with four units of analysis: the US government, partner nation, host nation, and nongovernmental organizations. Key stakeholders representing each unit were interviewed using open-ended questions that explored the experiences of each participant and their organization. Findings were analyzed using a priori domains from a proposed partnership theoretical framework. A documentary review of key policy, guidance, and planning documents was also conducted. RESULTS: Fifteen themes related to how and why hospital ship missions influence partnerships emerged from the 37 interviews and documentary review. The five most prominent included: developing relationships, developing new perspectives, sharing resources, understanding partner constraints, and developing credibility. Facilitators to joining the mission included partner nations seeking a regional presence and senior executive relationships. Enablers included historical relationships and host nation receptivity. The primary barrier to joining was the military leading the mission. Internal constraints included the short mission duration, participant resentment, and lack of personnel continuity. External constraints included low host nation and United States Agency for International Development (USAID) capacity. CONCLUSION: The research finds the idea of building partnerships exists among most units of analysis. However, the results show a delay in downstream effects of generating action and impact among the participants. Without a common partnership definition and policy, guidance, and planning documents reinforcing these constructs, achieving the partnership goal will remain challenging. Efforts should be made to magnify the facilitators and enablers while developing mitigation strategies for the barriers and constraints. This is the first study to scientifically assess the partnership impact of hospital ship missions and could support the DoD's effort to establish, enable, and sustain meaningful partnerships. Application of the findings to improve partnerships in contexts beyond hospital ship missions may be warranted and require further analysis. This unique opportunity could bridge the rift with humanitarian actors and establish, enable, and sustain meaningful partnerships with the DoD.