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Background The introduction of option B+—rapid initiation of lifelong antiretroviral therapy regardless of disease status for HIV-infected pregnant and breastfeeding women—can dramatically reduce HIV transmission during pregnancy, birth, and breastfeeding. Despite significant investments to scale-up Option B+, results have been mixed, with high rates of loss to follow-up, sub-optimal viral suppression, continued pediatric HIV transmission, and HIV-associated maternal morbidity. The Systems Analysis and Improvement Approach (SAIA) cluster randomized trial demonstrated that a package of systems engineering tools improved flow through the prevention of mother-to-child HIV transmission (PMTCT) cascade. This five-step, facility-level intervention is designed to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). This protocol describes a novel model for SAIA delivery (SAIA-SCALE) led by district nurse supervisors (rather than research nurses), and evaluation procedures, to serve as a foundation for national scale-up. Methods The SAIA-SCALE stepped wedge trial includes three implementation waves, each 12 months in duration. Districts are the unit of assignment, with four districts randomly assigned per wave, covering all 12 districts in Manica province, Mozambique. In each district, the three highest volume health facilities will receive the SAIA-SCALE intervention (totaling 36 intervention facilities). The RE-AIM framework will guide SAIA-SCALE’s evaluation. Reach describes the proportion of clinics and population in Manica province reached, and sub-groups not reached. Effectiveness assesses impact on PMTCT process measures and patient-level outcomes. Adoption describes the proportion of districts/clinics adopting SAIA-SCALE, and determinants of adoption using the Organizational Readiness for Implementing Change (ORIC) tool. Implementation will identify SAIA-SCALE core elements and determinants of successful implementation using the Consolidated Framework for Implementation Research (CFIR). Maintenance describes the proportion of districts sustaining the intervention. We will also estimate the budget and program impact from the payer perspective for national scale-up. Discussion SAIA packages user-friendly systems engineering tools to guide decision-making by frontline health workers, and to identify low-cost, contextually appropriate PMTCT improvement strategies. By integrating SAIA delivery into routine management structures, this pragmatic trial is designed to test a model for national intervention scale-up. Trial registration ClinicalTrials.gov NCT03425136 (registered 02/06/2018).

Background The Systems Analysis and Improvement Approach (SAIA) is an evidence-based package of systems engineering tools originally designed to improve patient flow through the prevention of Mother-to-Child transmission of HIV (PMTCT) cascade. SAIA is a potentially scalable model for maximizing the benefits of universal antiretroviral therapy (ART) for mothers and their babies. SAIA-SCALE was a stepped wedge trial implemented in Manica Province, Mozambique, to evaluate SAIA’s effectiveness when led by district health managers, rather than by study nurses. We present the results of a qualitative assessment of implementation determinants of the SAIA-SCALE strategy during two intensive and one maintenance phases. Methods We used an extended case study design that embedded the Consolidated Framework for Implementation Research (CFIR) to guide data collection, analysis, and interpretation. From March 2019 to April 2020, we conducted in-depth individual interviews (IDIs) and focus group discussions (FGDs) with district managers, health facility maternal and child health (MCH) managers, and frontline nurses at 21 health facilities and seven districts of Manica Province (Chimoio, Báruè, Gondola, Macate, Manica, Sussundenga, and Vanduzi). Results We included 85 participants: 50 through IDIs and 35 from three FGDs. Most study participants were women (98%), frontline nurses (49.4%), and MCH health facility managers (32.5%). An identified facilitator of successful intervention implementation (regardless of intervention phase) was related to SAIA’s compatibility with organizational structures, processes, and priorities of Mozambique’s health system at the district and health facility levels. Identified barriers to successful implementation included (a) inadequate health facility and road infrastructure preventing mothers from accessing MCH/PMTCT services at study health facilities and preventing nurses from dedicating time to improving service provision, and (b) challenges in managing intervention funds. Conclusions The SAIA-SCALE qualitative evaluation suggests that the scalability of SAIA for PMTCT is enhanced by its fit within organizational structures, processes, and priorities at the primary level of healthcare delivery and health system management in Mozambique. Barriers to implementation that impact the scalability of SAIA include district-level financial management capabilities and lack of infrastructure at the health facility level. SAIA cannot be successfully scaled up to adequately address PMTCT needs without leveraging central-level resources and priorities. Trial registration ClinicalTrials.gov, NCT03425136 . Registered on 02/06/2018.

Background Striving to foster collaboration among countries suffering from maternal and child health (MCH) inequities, the MASCOT project mapped and analyzed the use of research in strategies tackling them in 11 low- and middle-income countries. This article aims to present the way in which research influenced MCH policies and programs in six of these countries – three in Africa and three in Latin America. Methods Qualitative research using a thematic synthesis narrative process was used to identify and describe who is producing what kind of research, how research is funded, how inequities are approached by research and policies, the countries’ research capacities, and the type of evidence base that MCH policies and programs use. Four tools were designed for these purposes: an online survey for researchers, a semi-structured interview with decision makers, and two content analysis guides: one for policy and programs documents and one for scientific articles. Results Three modalities of research utilization were observed in the strategies tackling MCH inequities in the six included countries – instrumental, conceptual and symbolic. Instrumental utilization directly relates the formulation and contents of the strategies with research results, and is the least used within the analyzed policies and programs. Even though research is considered as an important input to support decision making and most of the analyzed countries count five or six relevant MCH research initiatives, in most cases, the actual impact of research is not clearly identifiable. Conclusions While MCH research is increasing in low- and middle-income countries, the impact of its outcomes on policy formulation is low. We did not identify a direct relationship between the nature of the financial support organizations and the kind of evidence utilization within the policy process. There is still a visible gap between researchers and policymakers regarding their different intentions to link evidence and decision making processes.

Introduction Efforts to implement and take to scale highly efficacious, low‐cost interventions to prevent mother‐to‐child HIV transmission (pMTCT) have been a cornerstone of reproductive health services in sub‐Saharan Africa for over a decade. Yet efforts to increase access and utilization of these services remain far from optimal. This study developed and applied an approach to systematically classify pMTCT performance to identify modifiable health system factors associated with pMTCT performance which may be replicated in other pMTCT systems. Methods Facility‐level performance measures were collected at 30 sites over a 12‐month period and reviewed for consistency. Five combinations of three indicators (1. HIV testing; 2. CD4 testing; 3. antiretroviral prophylaxis and combined antiretroviral therapy initiation) were compared including a composite of all three, a combination of 1. and 3., and each individually. Approaches were visually assessed to describe facility performance, focusing on rank order consistency across high, medium and low categories. Modifiable and non‐modifiable factors were ascertained at each site and ranking process was reviewed to estimate association with facility performance through unadjusted Chi‐square tests and logistic regression. After describing factors associated with high versus low performing pMTCT clinics, the effect of inclusion of the 10 middle performers was assessed. Results The indicator most consistently associated with the reference composite indicator (HIV testing, antiretroviral prophylaxis and combined antiretroviral therapy) was the single measure of antiretroviral prophylaxis and combined antiretroviral therapy. Lower performing pMTCT clinics ranked consistently low across measurement strategies; high and middle performing clinics demonstrated more variability. Association between clinic characteristics and high pMTCT performance varied markedly across ranking strategies. Using the reference composite indicator, larger catchment area, higher number of institutional deliveries, onsite CD4 point‐of‐care capacity, and higher numbers of nurses and doctors were associated with high clinic performance while clinic location, NGO support, women's support group, community linkages patient‐tracking systems and stock‐outs were not associated with high performance. Conclusions Classifying high and low performance provided consistent results across ranking measures, though granularity was improved by aggregating middle performers with either high or low performers. Human resources, catchment size and utilization were positively associated with effective pMTCT service delivery.

Background The objective of the prevention of Mother-to-Child Transmission (pMTCT) cascade analysis tool is to provide frontline health managers at the facility level with the means to rapidly, independently and quantitatively track patient flows through the pMTCT cascade, and readily identify priority areas for clinic-level improvement interventions. Over a period of six months, five experienced maternal-child health managers and researchers iteratively adapted and tested this systems analysis tool for pMTCT services. They prioritized components of the pMTCT cascade for inclusion, disseminated multiple versions to 27 health managers and piloted it in five facilities. Process mapping techniques were used to chart PMTCT cascade steps in these five facilities, to document antenatal care attendance, HIV testing and counseling, provision of prophylactic anti-retrovirals, safe delivery, safe infant feeding, infant follow-up including HIV testing, and family planning, in order to obtain site-specific knowledge of service delivery. Results Seven pMTCT cascade steps were included in the Excel-based final tool. Prevalence calculations were incorporated as sub-headings under relevant steps. Cells not requiring data inputs were locked, wording was simplified and stepwise drop-offs and maximization functions were included at key steps along the cascade. While the drop off function allows health workers to rapidly assess how many patients were lost at each step, the maximization function details the additional people served if only one step improves to 100% capacity while others stay constant. Conclusions Our experience suggests that adaptation of a cascade analysis tool for facility-level pMTCT services is feasible and appropriate as a starting point for discussions of where to implement improvement strategies. The resulting tool facilitates the engagement of frontline health workers and managers who fill out, interpret, apply the tool, and then follow up with quality improvement activities. Research on adoption, interpretation, and sustainability of this pMTCT cascade analysis tool by frontline health managers is needed. Trial Registration ClinicalTrials.gov NCT02023658 , December 9, 2013