Implementation Research Study Research Articles (Page 1)

Background Non-communicable diseases (NCDs), particularly hypertension and diabetes, represent a rising public health burden in India, driven by lifestyle changes and complex social determinants. In Karnataka’s Chamarajanagar district, previous research identified a high NCD prevalence alongside systemic gaps in the continuum of care and multisectoral action. The IMPACT NCD project is an implementation research study that aims to strengthen the primary healthcare system's capacity and foster multisectoral collaboration for effective NCD prevention and management. Its primary scientific objective is to conduct a rigorous implementation evaluation. This evaluation examines the causal pathways and contextual factors that influence the success of these real-world interventions to understand what works, for whom, and why. Methodology The study is guided by a theory-driven implementation research design. Interventions, developed using a participatory approach, include two main components: Capacity building and technical support for healthcare workers at Ayushman Arogya Mandirs (AAMs) on NCD screening, follow-up, and the continuum of care. Sensitisation workshops for local elected officials, police personnel, and students in grades 8 to 12. The effectiveness of these strategies will be evaluated using a sequential mixed-methods approach to understand the pathways and mechanisms of change. First, quantitative program data will be analysed using Principal Component Analysis (PCA) and cluster analysis to stratify primary units by performance. Subsequently, a purposive sample of high-performing and low-performing units will be selected for in-depth qualitative analysis through interviews and observations to test and refine the project's Theory of Change. Discussion The project’s strong focus on implementation evaluation is critical. By moving beyond simply measuring outcomes to understanding the underlying processes and contextual factors, the study aims to identify mechanisms that drive implementation success and sustainability mechanisms of change, the study will generate crucial insights into how complex, multisectoral NCD programs can be effectively embedded within existing government systems.

BackgroundDelivering quality primary healthcare to the urban population has been challenging in many developing countries including Bangladesh. With a fragmented and pluralistic urban health system, the country experiences major hurdles in the provision of primary healthcare to its urban dwellers. Since 2021, an urban primary healthcare model called ‘Aalo Clinic’ is being piloted to serve the low-income urban population in Bangladesh. With an aim to ensure universal health coverage for the urban population, the model delivers an essential package of health services. We aimed to assess the implementation effect of this pilot model on the utilization of healthcare from medically trained providers (MTPs) for the management of acute illness.MethodsFollowing a cross-sectional study design, an implementation research study was conducted between October 2021 and August 2023 in the Korail, Mirpur, Shyampur, Dhalpur, and Tongi-Ershadnagar slums. Cross-sectional household surveys were conducted at baseline and end-line, involving over 2000 households in each round. Descriptive analysis and Chi-squared test were performed to assess the changes in healthcare utilization from MTPs, and logistic regression models were applied to assess the effectiveness of the model on healthcare utilization from MTPs while controlling for other covariates.ResultsThe utilization of healthcare from MTPs was significantly higher in the end-line (9.81% from Aalo Clinic and 18.6% from non-Aalo Clinic MTPs) compared to the baseline (0.64% from Aalo Clinic and 17.68% from non-Aalo Clinic MTPs). Healthcare utilization from local drug stores declined from 80.56% at baseline to 67.19% at end-line. Multivariate logistic regression showed respondents were 12.43 times more likely (95% CI: 7.49–20.63) to use Aalo Clinic services at end-line, indicating increased uptake of medically trained providers following the model’s implementation.ConclusionsThe Aalo Clinic Model was effective in influencing healthcare-seeking pattern of the slum populations and enhancing the utilization of qualified care from MTPs. The study supports replicating the model within existing healthcare structures and scaling it nationwide to advance universal health coverage in urban Bangladesh, contingent on sustained government funding for its operations.

Non-Communicable Diseases (NCDs) are now a leading cause of mortality and morbidity globally, and mental illness is a significant part of it. In India, the treatment gap for common mental disorders is over 80%. In order to bridge this gap, mental health treatment models recommend task-shifting to non-specialists and integration of mental health care into general healthcare services. Other NCDs are being managed effectively by non-specialist healthcare workers (HCWs) at primary care, and mental illness and substance misuse are highly comorbid with other NCDs; hence, integrating mental health care within the NCD services and care framework seems logically feasible and effective. However, country-specific characteristics pose a significant challenge to the implementation of integrated care for mental disorders and NCDs. The primary objective of this study includes the development and implementation of a service delivery model that would result in at least 70% coverage of screening, linkage to care, and management of common mental disorders and substance use disorders (MSUD) among persons seeking care for NCDs at public health facilities. Secondary objectives include assessment of the feasibility of adoption of the implementation model by the health care system and to evaluate the cost of the mental health service strengthening intervention package from the health system’s and the patient’s perspectives. It will be a multi-site implementation research study, employing a mixed-methods quasi-experimental, within-site, three-phase, single-arm, interrupted time series design. The implementation model comprises screening, treatment, and linkage of mental health services integrated into NCD care in at least three blocks in each of the seven selected districts of the seven selected states of India, which are geographically far apart. The expected outcome would be to increase the proportion of patients screened and managed for MSUDs among persons seeking care for NCDs at the public health facilities. The results of this implementation research will provide a roadmap for scaling up of integrated MSUDs services within general healthcare.Trial registrationClinicalTrials.gov CTRI/2024/08/072748.

ObjectiveMalawi’s prisons are overcrowded, contributing to tuberculosis (TB) and Human Immunodeficiency Virus (HIV) transmission and service delivery gaps for both conditions. We applied an empirically supported three-stage model of HIV/TB care to guide the improvement of TB/HIV service delivery in select Malawian prisons.DesignWe conducted a pilot implementation research study using multimethods from May 2022 to April 2023.SettingTwo semi-urban prisons in Malawi.ParticipantsWe purposively sampled participants detained at the study sites during the study period.Methods and interventionWe collected data on sociodemographics, medical history and screening results for sexually transmitted infections (STIs), HIV and TB results. We conducted in-depth interviews with prison professional staff and used content analysis to explore the feasibility of implementing the three-stage model of HIV and TB care in Malawian prisons.ResultsMean participant age was 35 years (SD 12.2 years). We screened 100 out of 647 (15%) incarcerated people for TB/HIV according to the three-stage model and identified the following: five cases of TB disease; two cases of HIV-associated TB; seven persons living with HIV; eight persons diagnosed and treated for STIs, including genital ulcer disease and syphilis. For those tested for HIV at entry, midpoint and exit screening, there was no documented case of seroconversion during the incarceration period. There was evidence of potential STI transmission during incarceration, as suggested by a 4% rate of new urethral discharge among participants. Qualitative data suggest that it is feasible to implement the three-stage model of HIV/TB in the Malawi prison setting.ConclusionsWe found evidence of HIV, TB and STIs among incarcerated people in two semi-urban prisons in Malawi, with low HIV status awareness on prison entry. It is feasible to implement the three-stage model of HIV/TB in prison settings, although with material support to overcome implementation challenges. Coordination with Ministry of Health officials could facilitate model feasibility and sustainability in Malawi’s prisons.

IntroductionNon-communicable diseases (NCDs) are a leading cause of global mortality, disproportionately affecting low and middle-income countries (LMICs). Physical inactivity, a key contributor to NCDs, is prevalent worldwide despite evidence supporting the health benefits of physical activity (PA). Cities, while often associated with barriers to PA, also present unique opportunities to enhance PA through systemic, context-sensitive interventions or so-called actions. However, evidence on effective city-level PA strategies, particularly in LMICs, remains limited. The CITY based interventions to stimulate active MOVEment for health (CITY-MOVE) project aims to accelerate, support and evaluate the implementation of PA actions at the city level by adapting the WHO Global Action Plan on Physical Activity into locally relevant strategies across six cities worldwide, accompanied by a cross-contextual evaluation framework to ensure transferability and scalability.Methods and analysisThis multicase study examines 13 PA actions in six cities (Bogotá, Lima, Kampala, Antwerp, Rotterdam and Ljubljana) across three continents, addressing both early (design and implementation) and late (evaluation) action stages. Early-stage actions employ action research in Living Labs to codesign and implement PA initiatives with local stakeholders, while late-stage interventions focus on retrospective evaluations of implementation outcomes. The framework integrates the Medical Research Council guidance on complex interventions with the Context and Implementation of Complex Interventions. Mixed methods are employed, including document review, interviews, participatory workshops and quantitative analysis of PA and NCD indicators. A cross-contextual Multi-Criteria Decision Analysis (MCDA) framework will synthesise findings to inform scalability and transferability of actions.Ethics and disseminationEthics approvals were obtained from local review boards in the participating cities.Dissemination will occur at three levels: local, regional and global. Locally, findings will be shared with city authorities, non-governmental organisations (NGOs) and healthcare providers through Living Labs and policy dialogues. At the regional level, knowledge will be spread across cities in Europe, Latin America and East Africa through Communities of Practice and the use of tools like the MCDA framework. Globally, the project will contribute to the scientific community and international organisations such as the WHO and UN-Habitat, by sharing results through open access publications, conferences and global networks to ensure widespread dissemination and sustainability of the project’s impacts.Registration detailsThis study and its outcomes are publicly accessible on OSF (https://osf.io/mn8zd/) and ZENODO (https://zenodo.org/communities/citymove/).

Both New York State (NYS) and the United States have experienced heightened levels of opioid overdose death and prevalence of opioid use in recent decades. While evidence-based practices (EBPs) to address opioid use and prevent overdose fatalities exist, their reach in many communities remains limited. Persistent systems-level barriers must be overcome to support and sustain effective EBP implementation. This paper describes the Systems Think Tank (STT), a community-engaged approach that promoted the use of systems thinking skills and system dynamics (SD) modeling for the purpose of local action planning and decision-making to select, employ, and monitor community-based strategies to prevent opioid overdose fatalities. A core modeling team launched the STT in support of the New York site of the HEALing Communities Study (NY HCS), a multi-site implementation research study funded by the HEAL Initiative. The modeling team worked collaboratively with purposively recruited NY HCS community coalitions located in counties across NYS. With the assistance of the modeling team, coalitions and their implementation teams explored SD modeling results and conducted strategy analyses using a web-based interface to simulate the local implementation of specific EBPs and inform action and sustainability planning. To describe the implementation of the STT, we reflect on our experiences with two NY HCS community coalitions and their implementation teams through two case studies. These case studies describe how SD modeling and systems thinking activities supported NY HCS coalitions during the CTH intervention by generating unique data and insights to inform coalition decision-making. We found that participation in the STT helped coalitions clarify the drivers of opioid overdose within their counties and identify potential effective strategies to mitigate overdose fatalities in the near future and long-term. The narratives presented in this paper may be useful for those incorporating SD modeling and systems thinking into community-engaged implementation research.

BackgroundLabor companionship, the presence of a woman's person of choice during childbirth, has benefits to both woman and baby and is recommended by the World Health Organization since 2012. However, implementation remains sub-optimal, especially in low-and-middle-income countries (LMICs). This study aimed to understand the maturity of labor companionship implementation in eight low-and-middle income countries with focus on the policy and facility environment.MethodsThis was a multi-country study nested in two hospital-based implementation research studies: Action Leveraging Evidence to Reduce perinatal mortality and morbidity in Sub-Saharan Africa (ALERT) study and the QUALIty DECision-making by women and providers for appropriate use of caesarean section (QUALI-DEC) study. We included 48 hospitals from eight countries: Argentina, Burkina Faso, Thailand and Viet Nam (QUALI-DEC) and four from each of Benin, Malawi, Tanzania and Uganda (ALERT). We used data from (i) a document review, including national policy documents and (ii) health facility readiness assessment, including physical layouts of maternity wards, all collected between December 2019 and April 2021. Our analysis included two steps, (1) a structured data abstraction with coding to pre-defined categories to analyse the national polices and available resources on a facility level which informed the (2) categorization of implementation maturity in three implementation phases modelled by the framework by Bergh et al. and the logic model developed by Bohren et al.ResultsThree of the eight countries lacked any national-level companionship policies, four had some mentioning and only one had detailed guidance on roles of labor companions and implementation guidelines. The physical outlines of maternity wards varied greatly, and lack of space was one of the main implementation barriers to all countries except Argentina. We classified Benin, Thailand and Viet Nam in the pre-implementation phase because of missing guidelines and limited implementation; Burkina Faso, Malawi, Uganda and Tanzania in the early implementation phase; and Argentina in the institutionalization phase where policies and facility resources were conducive.ConclusionSuccessful implementation was supported by concrete and contextualized implementation guidance. To move to high implementation levels, supporting policies, guidelines and structural changes in the maternity wards are needed.

BackgroundAnemia among women of reproductive age has remained highly prevalent globally. Intravenous (IV) iron is well tolerated and proven effective for treating postpartum iron deficiency anemia in high-income countries, but evidence from LMICs, where oral iron is standard treatment, is limited. The PRIORITY trial will test the effectiveness of IV iron compared to oral iron for postpartum women with moderate anemia in eight LMIC sites. An implementation research (IR) study will be conducted alongside the PRIORITY trial in India and Pakistan to gather information on the intervention characteristics and the implementation process, and to assess feasibility, acceptability, fidelity, and cost of implementation for providing IV iron to postpartum women with moderate iron deficiency anemia.MethodsThe PRIORITY IR study will use a mixed methods convergent parallel design guided by two frameworks: the Consolidated Framework for Implementation Research and Proctor’s implementation outcomes. The IR study will be conducted in the Belagavi, India and Karachi, Pakistan PRIORITY trial sites. Participants will include postpartum women in the IV iron intervention arm of the trial, family members, health workers administering IV iron, hospital administrators, postpartum women who refuse to be part of the trial (Pakistan only), and postpartum women in the oral iron arm of the trial (India only). Data collection methods will include surveys, in-depth interviews, a supervision checklist, and a cost assessment. Survey and supervision checklist data will be analyzed descriptively. Interview data will be analyzed using a directed content analysis approach.DiscussionThe PRIORITY IR study will contribute important information about implementation processes and strategies and feasibility, acceptability, fidelity, and costs for postpartum IV iron implementation. Results of the study can provide guidance for implementing effective anemia treatment in LMIC contexts with a high anemia burden.RegistrationNCT05590260 (21/10/2022),CTRI/2022/10/046632 (19/10/2022),CTRI/2023/05/053302 (31/05/2023).

BackgroundMalaria, acute respiratory infections (ARIs), and diarrhoea are primary causes of morbidity and mortality among children under five years old in Ghana. Despite the implementation of various interventions, the nation struggles to meet relevant health and policy targets. While the potential of mobile health interventions to enhance child health outcomes has been recognized, their impact on prevalent childhood illnesses remains insufficiently explored. This implementation research study aimed to evaluate the effect of a mobile health information system (mHIS) intervention on common childhood illnesses among under-five children residing in rural health districts of Ghana.MethodsIn this quasi-experimental study, we enrolled all children under five years old from randomly selected clusters within the rural intervention and control health districts in the Ashanti region, Ghana between November 2018 and December 2021. The Reach, Effectiveness, Adoption Implementation and Maintenance (RE-AIM) framework was used to design and implement the intervention. The intervention involved a mobile phone-based information system to monitor childhood conditions, offer telemedicine consultations, and deliver child health promotion messages on nutrition and management of common childhood illnesses to caregivers. By employing the average treatment effect (ATET) and difference-in-difference (DiD) analyses, we assessed outcome disparities in diarrhoea, cough, and presumptive malaria.ResultsThe incidence of diarrhoea and malaria decreased in the intervention group. The ATET analysis indicated pre-intervention disparities in presumptive malaria with a post-intervention difference between the groups for diarrhoea and presumptive malaria. Results related to cough, used as a proxy for ARIs, did not provide conclusive results across the intervention and control sites based on this intervention. However, the DiD model highlighted an overall statistically significant reduction in diarrhoea and presumptive malaria.ConclusionThis study underscores the effectiveness of a mobile phone-based health information system intervention in curbing common childhood morbidities, particularly diarrhoea and presumptive malaria, among under-five children in rural Ghana. This approach demonstrates promise in advancing child health outcomes and contributing to the reduction of prevalent illnesses in resource-constrained settings.

Background/Objectives: The Tropis® ID device (PharmaJet®), a needle-free injection system, is a World Health Organization prequalified, hand-held device, which delivers intradermal injections without the use of needles and has previously been used for the delivery of fractional doses of inactivated polio vaccine (fIPV) in campaign and house-to-house settings. This implementation research study aimed to comparatively evaluate the vaccine coverage, cost, feasibility, and acceptability of using Tropis for fIPV for routine immunizations in two states in Nigeria (Kano and Oyo). Methods: The study included: (i) a cluster randomized trial (22 intervention facilities using Tropis for fIPV and 30 control facilities using the standard of care [SoC-full-dose IPV]) to assess the effectiveness in terms of improving the coverage of two doses of IPV, using a coverage survey involving 3433 children (aged 3-12 months); (ii) a pre- and post-implementation micro-costing evaluation involving the intervention facilities to estimate the costs; and (iii) mixed methods assessments (post-training assessment, provider survey, key informant interviews, and focus group discussions) to assess the feasibility and acceptability of fIPV delivery using Tropis. Results: The intention-to-treat analysis among the 3433 children surveyed did not show any difference between the intervention and control groups, primarily due to low compliance (approximately 50% of target beneficiaries reported Tropis use). The more relevant per protocol analysis, adjusting for lower compliance, showed that among those vaccinated with Tropis, second dose IPV coverage was 11.2% higher than the SoC. The delivery of fIPV using Tropis compared to the SoC resulted in incremental program cost savings, ranging from USD 0.07 to USD 1.00 per dose, administered across the scenarios evaluated. High acceptability was seen amongst caregivers (94%), and 95% of healthcare workers preferred Tropis over the SoC. Conclusions: Tropis is effective, feasible, acceptable, and saves costs when used as part of routine immunization programs.

BackgroundMost studies on integration of neglected tropical disease programmes have focused on mass drug administration or environmental measures rather than Disease Management, Disability and Inclusion (DMDI). The study reported here explored integration of a DMDI care package across three disabling, stigmatising neglected tropical diseases (podoconiosis, lymphatic filariasis and leprosy), across physical and mental health, and into the state health system.MethodsWe conducted this pre-post study, the third phase of an implementation research project, in two predominantly rural districts in north-west Ethiopia in 2021. We assessed physical and mental health outcomes on 192 affected persons and 817 community members at baseline and 6 months after initiation of the integrated care package, implemented by nurses and health officers. Key outcomes measured were disability (using WHODAS-2.0), depression (Patient Health Questionnaire-9), discrimination (Discrimination and Stigma Scale), internalised stigma (Internalized Stigma Related to Lymphoedema), quality of life (Dermatology Life Quality Index) and social support (Oslo-3 Social Support Scale). Mixed effects linear regression models were used to estimate change in outcomes between baseline and 6 months after initiation of the care package. We also evaluated implementation feasibility and conducted cost-effectiveness analysis.ResultsAmong 221 patients, improvements were observed in foot (− 2.3 cm; 95% CI: − 2.2, − 1.8) and leg circumference (− 1.8 cm; − 2.0, − 1.7) and acute attacks (6.2; 0.0, 6.6); these were statistically significant at the 5% level. Reductions were seen in disability scores (− 6.5; − 7.6, − 5.5), depression (− 5.3; − 6.6, − 4.6), discrimination (− 3.3; − 4.2, − 2.3), internalised stigma (− 3.7; − 4.6, − 2.8), quality of life (− 4.0; − 4.8, − 3.2), and alcohol use (− 1.6; − 2.4, − 0.8). No notable changes were found in the presence of wounds or moss, or perceived social support. Across 817 community members, there was strong evidence that knowledge improved, and stigmatising attitudes and social distance reduced. The intervention was cost-effective in reducing depression and disability and improving health-related quality of life and feasible to implement.ConclusionThe integrated intervention is feasible and cost-effective even in remote areas and appears ideal for scale-up to other endemic regions in Ethiopia and other countries.

Background: There is widespread agreement on the potential of multisectoral action to address the social determinants of maternal health. We conducted an implementation research study in Meghalaya, a northeastern Indian state with a high burden of maternal mortality where the government initiated "Rescue Mission" to strengthen the health system and to address underlying determinants to improve maternal health indicators. The initiative was grounded in building state capability and decentralised leadership. Objective: We developed a theory of change and examined implementation barriers and enablers through an implementation research study with government and community actors and institutions. Methods: We conducted multiple rounds of qualitative data collection over a period of eighteen months across six districts. Participants included primary care providers in the public health system and frontline workers in thirty sampled facilities. We also interviewed officials across three government departments, observed meetings and met regularly in a feedback loop with government. Data were analysed thematically and synthesised according to pathways of change. Findings: The state institutionalised multisectoral collaboration across governance levels through building technical and adaptive leadership. Processes included joint meetings at the facility, district and state levels to develop action plans and facilitate collaboration, community engagement through frontline workers and decentralised use of data. Strength of participation by different sectors varied widely; non‑health cadres reported challenges such as being accountable to multiple departments. Political priority and administrative leadership were the key elements of the State's ability to implement a multisectoral approach. Overall, health outcomes improved and the State largely achieved its commitment to building technical skills, but also recognised the need for further investments to develop a sense of purpose amongst government officials. Conclusions: Meghalaya's experience in multisectoral collaboration demonstrates the potential of health systems reform grounded in a state capabilities enhancement approach, with a focus on participation and building decentralised leadership.

Influenza presents a significant global health challenge, with seasonal epidemics causing 3 to 5 million cases of severe illness and 290,000 to 650,000 respiratory deaths annually. In Bhutan, the highest rates of influenza-associated hospitalizations were observed among children under 5 years of age emphasizing the need for robust surveillance and preparedness. This study aims to assess influenza severity in Bhutan using the World Health Organization's (WHO) Pandemic Influenza Severity Assessment (PISA) framework. By integrating syndromic and influenza-specific data, we establish national-level baseline and threshold values for influenza activity. The WHO Average Curve Method was employed to establish seasonal and intensity thresholds, categorizing influenza severity based on historical data from 2016 to 2019 and 2023. Analysis of influenza activity revealed near-continuous activity with two annual peaks. Thresholds for epidemic, moderate, high, and extraordinary levels of transmissibility and morbidity were determined. The 2019 season exhibited the highest transmissibility and morbidity, with significant variability in intensity across different seasons. The study demonstrates the effectiveness of the PISA framework in assessing influenza severity in Bhutan. The established thresholds provide a valuable tool for public health decision-making, enhancing the country's preparedness for both seasonal and pandemic influenza. These findings underscore the importance of maintaining and adapting surveillance systems to monitor influenza activity year-round.

Implementation of Child Life Specialists to improve outcomes in flexible endoscopic evaluation of swallowing in children.

IntroductionAntimicrobial resistance is a major global health threat, driven largely by the misuse and overuse of antibiotics. Point-of-care (POC) tests for inflammatory biomarkers like procalcitonin (PCT) have shown promise in...

ClinicalTrials.gov CTRI/2024/08/072748.

Abstract This review paper systematically examines implementation research studies reported in the journals of the Nordic countries focusing on mathematics education innovations implemented in Nordic countries over the past three decades. We aimed to identify the types of innovations reported, the objectives of the research and the scale of the projects. Our review categorized the innovations into four types: new teaching methods, new tools, new learning methods, and curriculum reforms and textbook innovations. The most frequently reported innovation was implementing new teaching methods. Our findings reveal that the majority of papers are to be found in NOMAD and SJER, and that studies reported here focus on small implementation research projects, either as parts of larger initiatives or as standalone experiments. One observation is, however, many reports lack details on the intentions or challenges of scaling up these projects. The impact sheet to this article can be accessed at 10.6084/m9.figshare.27153099.

Abstract Non-communicable diseases (NCD) account for 74% of global mortality. Approximately 86% of all premature deaths occur in low- and middle-income countries majorly attributed to lifestyle changes or behavioural risk factors. The theory-based behaviour change interventions (BCIs) appear promising, but their applicability is not explored within the national programmes. The current paper aims to review the effectiveness of theory-based BCI in modifying the NCD risk factors and provide insights into the national NCD programmes. Interventions conducted to evaluate theory-based BCIs between 2002 and 2022 in modifying behavioural risk factors for NCDs were identified from multiple databases (PubMed, Scopus, Google Scholar and Cochrane Library) for systematic review. The final analysis included 35 studies that used theories and models that broadly come under one of the four approaches, i.e. intrapersonal (targets inherent individual factors for behaviour change), interpersonal (targets the family or groups), community (target socio-cultural ecosystems) and integrated (combination of other three approaches). Twenty-seven studies showed significant results. The highest number of studies were of interpersonal approach using socio-cognitive theory and integrated (11 each), and strength of evidence was moderate for both. Twenty-six studies focused on physical inactivity and unhealthy diet. The review supports the effectiveness of behaviour change interventions for mitigating NCD risk factors. Further efforts, including implementation research study methods, should be directed to evaluate effects of these interventions on population health outcomes within specific cultural and social contexts.

Postpartum hemorrhage (PPH) remains a major concern in crisis-affected settings. There is a lack of strategies for implementing heat-stable carbetocin (HSC) and tranexamic acid (TXA) in humanitarian settings. This study aims to investigate the impact of a capacity-strengthening package on the utilization of uterotonics for PPH prevention, PPH detection, and utilization of TXA for PPH treatment in basic obstetric care clinics in humanitarian settings in Uganda. A multi-stepped implementation research study was conducted, wherein six select facilities utilized an intervention package encompassing provider training, an online community of practice, and wall-displayed PPH algorithms. Facilities were conveniently assigned to the same study sequence: T1 (routine care), a transition period for training; T2 (package without HSC and TXA); T3 (package with HSC); and T4 (package with HSC and TXA). The primary outcomes assessed trends in prophylactic uterotonic use (including HSC), visual diagnosis of hemorrhage, and HSC and TXA use for hemorrhage treatment. Analysis followed an intention-to-treat approach, adjusting for cluster effect and baseline characteristics. Pan-African Clinical Trials Registry: PACTR202302476608339. From April 10, 2022, to April 4, 2023, 2299 women were recruited (T1: 643, T2: 570, T3: 580, T4: 506). Over 99% of all women received prophylactic uterotonics across the four phases, with oxytocin alone primarily used in T1 (93%) and T2 (92%) and HSC alone in T3 (74%) and T4 (54%) (T4-T1 95% CI: 47.8-61.0). Hemorrhage diagnosis ranged from 1% to 4%. For hemorrhage treatment, universal oxytocin use in T1 and T2 decreased in T3 and T4 after HSC introduction (T4-T1: 33%-100%; 95% CI: -100.0 to -30.9), and TXA use increased in T4 (T4-T1: 33%-0%; 95% CI: -2.4 to 69.1). An intervention package to reinforce providers' capacity to prevent and treat PPH can result in substantial HSC utilization and a moderate TXA adoption in cold-chain-challenged humanitarian settings. It could be scaled up with continuous capacity development and supportive supervision to mitigate confusion between existing and new medications, such as the decreased use of oxytocin for PPH treatment. Maintaining investments in cold-chain strengthening remains critical to ensure the quality of oxytocin.

Maternal mortality remains one of the primary global health challenges of the 21st century, despite major medical advances in the field. Although solutions are available, inequities determine where mothers die, with the majority of maternal deaths occurring in low- and middle-income countries (LMICs). More than one-third of maternal deaths are related to obstetric hemorrhage and most commonly postpartum hemorrhage (PPH). Effective, quality-assured uterotonics significantly reduce PPH-related morbidity and mortality. Updated World Health Organization (WHO) recommendations on uterotonics used for PPH prevention include the addition of heat-stable carbetocin (HSC) to the suite of prophylactic uterotonic agents as well as the use of tranexamic acid (TXA) for PPH treatment. Both medicines are promising interventions in obstetric care. However, the introduction of these medicines faces numerous challenges to end-user access, such as decentralized procurement, time-consuming policy updates, market access barriers, lack of demand for quality-assured products, and inadequate systematic training and information provision, impeding access in many LMICs. Assessing the feasibility and acceptability of implementing these medicines in different resource settings can help bridge the gap between research and development to policy and practice, in an effort to reduce the significant health inequities facing women accessing the public health sector for quality care during labor and delivery. In this Special Collection, we explore the findings from mixed-methods implementation research studies in nine LMICs which support the acceptability and feasibility of HSC and TXA administration by healthcare providers, generating evidence to help inform the introduction and scale-up of these new and lesser-utilized PPH medicines.