Exploring the implementation of an SMS-based digital health tool on maternal and infant health in informal settlements.

BACKGROUND: The rapid urbanization of Kenya has led to an increase in the growth of informal settlements. There are challenges with access to maternal, newborn, and child health (MNCH) services and higher maternal mortality rates in settlements. The Kuboresha Afya Mitaani (KAM) study aimed to improve access to MNCH services. We evaluate one component of the KAM study, PROMPTS (Promoting Mothers through Pregnancy and Postpartum), an innovative digital health intervention aimed at improving MNCH outcomes. PROMPTS is a two-way AI-enabled SMS-based platform that sends messages to pregnant and postnatal mothers based on pregnancy stage, and connects mothers with a clinical help desk to respond and refer urgent cases in minutes. METHODS: PROMPTS was rolled out in informal settlements in Mathare and Kawangware in Nairobi County. The study adopted a pre-post intervention design, comparing baseline and endline population outcomes (1,416 participants, Baseline = 678, Endline = 738). To further explore PROMPTS's effect, outcomes were compared between endline participants enrolled and not enrolled in PROMPTS (738 participants). Outcomes related to antenatal (ANC) and postnatal (PNC) service uptake and knowledge were assessed using univariate and multivariate linear and logistic regression. RESULTS: Between baseline and enldine, mothers were 1.85 times more likely to report their babies and 1.88 times more likely to report themselves being checked by a provider post-delivery. There were improvements in moms and babies receiving care on time. 45% of the 738 endline participants were enrolled in the PROMPTS program, with 87% of these participants sending at least one message to the system. Enrolled mothers were 2.28 times more likely to report completing four or more ANC visits relative to unenrolled mothers. Similarly, enrolled mothers were 4.20 times more likely to report their babies and 1.52 times more likely to report themselves being checked by a provider post-delivery compared to unenrolled mothers. CONCLUSIONS: This research demonstrates that a digital health tool can be used to improve care-seeking and knowledge levels among pregnant and postnatal women in informal settlements. Additional research is needed to refine and target solutions amongst those that were less likely to enroll in PROMPTS and to further drive improved MNCH outcomes amongst this population.

A study protocol to investigate if acipimox improves muscle function and sarcopenia: an open-label, uncontrolled, before-and-after experimental medicine feasibility study in community-dwelling older adults.

INTRODUCTION: Sarcopenia is the age-associated loss of muscle mass and strength. Nicotinamide adenine dinucleotide (NAD) plays a central role in both mitochondrial function and cellular ageing processes implicated in sarcopenia. NAD concentrations are low in older people with sarcopenia, and increasing skeletal muscle NAD concentrations may offer a novel therapy for this condition. Acipimox is a licensed lipid-lowering agent known to act as an NAD precursor. This open-label, uncontrolled, before-and-after proof-of-concept experimental medicine study will test whether daily supplementation with acipimox improves skeletal muscle NAD concentrations. METHODS AND ANALYSIS: Sixteen participants aged 65 and over with probable sarcopenia will receive acipimox 250 mg and aspirin 75 mg orally daily for 4 weeks, with the frequency of acipimox administration being dependent on renal function. Muscle biopsy of the vastus lateralis and MRI scanning of the lower leg will be performed at baseline before starting acipimox and after 3 weeks of treatment. Adverse events will be recorded for the duration of the trial. The primary outcome, analysed in a per-protocol population, is the change in skeletal muscle NAD concentration between baseline and follow-up. Secondary outcomes include changes in phosphocreatine recovery rate by 31P magnetic resonance spectroscopy, changes in physical performance and daily activity (handgrip strength, 4 m walk and 7-day accelerometry), changes in skeletal muscle mitochondrial respiratory function, changes in skeletal muscle mitochondrial DNA copy number and changes in NAD concentrations in whole blood as a putative biomarker for future participant selection. ETHICS AND DISSEMINATION: The trial is approved by the UK Medicines and Healthcare Products Regulatory Agency (EuDRACT 2021-000993-28) and UK Health Research Authority and Northeast - Tyne and Wear South Research Ethics Committee (IRAS 293565). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community. PROTOCOL: Acipimox feasibility study Clinical Trial Protocol V.2 2/11/21. TRIAL REGISTRATION NUMBER: The ISRCTN trial database (ISRCTN87404878).

Effect of mentorship and a mHealth application in updating provider skills and knowledge in maternal and newborn care in two informal settlements of Nairobi.

BACKGROUND: Children and women in urban informal settlements have fewer choices to access quality maternal and newborn health care. Many facilities serving these communities are under-resourced and staffed by fewer providers with limited access to skills updates. We sought to increase provider capacity by equipping them with skills to provide general and emergency obstetric and newborn care in 24 facilities serving two informal settlements in Nairobi. We present evidence of the combined effect of mentorship using facility-based mentors who demonstrate skills, support skills drills training, and provide practical feedback to mentees and a self-guided online learning platform with easily accessible EmONC information on providers' smart phones. METHODS: We used mixed methods research with before and after cross-sectional provider surveys conducted at baseline and end line. During end line, 18 in-depth interviews were conducted with mentors and mentees who were exposed, and providers not exposed to the intervention to explore effectiveness and experience of the intervention on quality maternal health services. RESULTS: Results illustrated marked improvement from ability to identify antepartum hemorrhage (APH), postpartum hemorrhage (PPH), manage retained placenta, ability to identify and manage obstructed labour, Pre-Eclampsia and Eclampsia (PE/E), puerperal sepsis, and actions taken to manage conditions when they present. Overall, out of 95 elements examined there were statistically significant improvements of both individual scores and overall scores from 29/95 at baseline (30.5%) to 44.3/95 (46.6%) during end line representing a 16- percentage point increase (p > 0.001). These improvements were evident in public health facilities representing a 17.3% point increase (from 30.9% at baseline to 48.2% at end line, p > 0.001). Similarly, providers working in private facilities exhibited a 15.8% point increase in knowledge from 29.7% at baseline to 45.5% at end line (p = 0.0001). CONCLUSION: This study adds to the literature on building capacity of providers delivering Maternal and Newborn Health (MNH) services to women in informal settlements. The complex challenges of delivering MNH services in informal urban settings where communities have limited access require a comprehensive approach including ensuring access to supplies and basic equipment. Nevertheless, the combined effects of the self-guided online platform and mentorship reinforces EmONC knowledge and skills. This combined approach is more likely to improve provider competency, and skills as well as improving maternal and newborn health outcomes.

Harnessing the Power of Behavioral Science: An Implementation Pilot to Improve the Quality of Maternity Care in Rural Madagascar.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading direct cause of maternal deaths worldwide, and women in low-income countries are at particularly high risk of dying from PPH-related consequences. Most deaths can be avoided through consistent provider adherence to prevention protocols and timely, appropriate management, yet providers do not consistently adhere to these best practices. USING BEHAVIORAL DESIGN TO DEVELOP SOLUTIONS TO IMPROVE PROVIDER CARE: We applied the behavioral design methodology to identify behavioral drivers, develop solutions, and build a program theory of change. Implementation research was conducted to understand the adoption, desirability, feasibility, and appropriateness of the solutions and explore suggestive findings related to impact. Data were collected through observation and in-depth interviews. Solutions developed included: (1) a timer to remind providers of the 1-minute window to administer oxytocin; (2) a glow-in-the-dark poster illustrating a simplified algorithm for PPH management; (3) badges to assign family members tasks to support providers during labor and delivery; and (4) a risk visualization exercise. Clinical mentors introduced the solutions during facility visits, and providers received orientation using videos. Solutions were piloted in 10 rural facilities in southeastern Madagascar during November-December 2020. RESULTS: Providers reported high adoption of the timers and task badges during routine deliveries. They remarked on the desirability and appropriateness of the timer, task badges, and algorithm poster, as well as the value of the cocreation process. Adoption of the timer solution shows promise in having a potential positive impact on increasing the awareness of and adherence to timely oxytocin administration. CONCLUSION: This work highlights the promise of applying behavioral science to identify underlying drivers of gaps in clinical practice and to develop innovative and desirable solutions to address them.

Lessons From a Behavior Change Intervention to Improve Provider-Parent Partnerships and Care for Hospitalized Newborns and Young Children in Kenya.

Enhancing respectful, responsive, integrative, and nurturing care for hospitalized newborns and young children (aged 0-24 months) is globally recognized but under-researched in low- and middle-income countries. Responsive, family-centered interventions target providers and parents and emphasize partnership in caring roles. From February 2020 to August 2021, we engaged in a participatory co-creation process with parents, providers, and newborn and child health stakeholders in Kenya to develop a comprehensive provider behavior change intervention and implemented it across 5 hospitals in Nairobi and Bungoma counties in Kenya. The multifaceted intervention included a 7-module orientation, feedback meetings, job aids, and psychosocial support-leveraging in-person and remote modalities-for providers working in newborn and pediatric units. We used a mixed-methods evaluation drawing on a pre-post provider survey, pre-post qualitative interviews with providers and parents, and a follow-up parental survey. There were significant post-intervention improvements in provider knowledge on safeguarding sleep, positioning and handling, and protecting skin. However, there were also significant reductions in providers' knowledge in identifying a child's pain, parental stress, and environmental stress. Among parents who received coaching from providers, there were higher levels of interpersonal communication between parent and provider, parental empowerment, and improved ability to provide integrated, responsive care to their child. Despite the challenges of implementing a provider-focused intervention to improve care for hospitalized newborns and young children during the global COVID-19 pandemic, we have demonstrated that it is feasible to implement a hybrid virtual and in-person process to influence several outcomes, including provider knowledge and practice, improved provider partnerships with parents, and parents' capacity to engage in the care of their newborn or young child.

Applying a Power and Gender Lens to Understanding Health Care Provider Experience and Behavior: A Multicountry Qualitative Study.

A limited but growing body of literature shows that health care providers (HCPs) in reproductive, maternal, and newborn health face challenges that affect how they provide services. Our study investigates provider perspectives and behaviors using 4 interrelated power domains-beliefs and perceptions; practices and participation; access to assets; and structures-to explore how these constructs are differentially experienced based on one's gender, position, and function within the health system. We conducted a framework-based secondary analysis of qualitative in-depth interview data gathered with different cadres of HCPs across Kenya, Malawi, Madagascar, and Togo (n=123). We find across countries that power dynamics manifest in and are affected by all 4 domains, with some variation by HCP cadre and gender. At the service interface, HCPs' power derives from the nature and quality of their relationships with clients and the community. Providers' power within working relationships stems from unequal decision-making autonomy among HCP cadres. Limited and sometimes gendered access to remuneration, development opportunities, material resources, supervision quality, and emotional support affect HCPs' power to care for clients effectively. Power manifests variably among community and facility-based providers because of differences in prevailing hierarchical norms in routine and acute settings, community linkages, and type of collaboration required in their work. Our findings suggest that applying power-and secondarily, gender lenses-can elucidate consistencies in how providers perceive, internalize, and react to a range of relational and environmental stressors. The findings also have implications on how to improve the design of social behavior change interventions aimed at better supporting HCPs.

Modeling Pathways to Describe How Maternal Health Care Providers' Mental Health Influences the Provision of Respectful Maternity Care in Malawi.

INTRODUCTION: Maternal health (MH) providers may experience traumatic events, such as maternal or fetal death, that can contribute to stress and burnout. Past trauma, poor working relationships, and under-resourced environments not only affect providers' own emotional well-being but also reduce their ability to provide respectful maternity care (RMC). METHODS: Data were collected in mid-2021 as a cross-sectional survey with 302 MH providers working in 25 maternities in 3 districts in Malawi to measure burnout, depression, and post-traumatic stress disorder (PTSD). We present a pathway model describing how these factors interact and influence RMC. We used the provider-reported person-centered maternity care scale to measure RMC; the Maslach Burnout Inventory, which examines emotional exhaustion, depersonalization, and professional accomplishment; and standard validated screening tools to measure the prevalence of depression and PTSD. RESULTS: Although levels of burnout varied, 30% of MH providers reported high levels of exhaustion, feelings of cynicism manifesting as depersonalization toward their clients (17%), and low levels of professional accomplishment (42%). Moderate to severe depression (9%) and suicidal ideation within the past 2 weeks (10%) were also recorded. Many (70%) reported experiencing an event that could trigger PTSD, and 12% reported at least 4 of 5 symptoms in the PTSD scale. Path analysis suggests that depression and emotional exhaustion negatively influence RMC, and depersonalization is mediated through depression. PTSD has no direct effect on RMC, but increased PTSD scores were associated with increased burnout and depression scores. Positive relationships with facility managers were significantly associated with increased RMC and decreased emotional exhaustion and depersonalization. CONCLUSION: Burnout will continue to be a challenge among MH providers. However, pragmatic approaches for improving teamwork, psychosocial, and managerial support for MH providers working in challenging environments may help mitigate burnout, improve MH provider well-being, and, in turn, RMC for women seeking MH services.

Exploring the accuracy of self-reported maternal and newborn care in select studies from low and middle-income country settings: do respondent and facility characteristics affect measurement?

BACKGROUND: Accurate data on the receipt of essential maternal and newborn health interventions is necessary to interpret and address gaps in effective coverage. Validation results of commonly used content and quality of care indicators routinely implemented in international survey programs vary across settings. We assessed how respondent and facility characteristics influenced the accuracy of women's recall of interventions received in the antenatal and postnatal periods. METHODS: We synthesized reporting accuracy using data from a known sample of validation studies conducted in Sub-Saharan Africa and Southeast Asia, which assessed the validity of women's self-report of received antenatal care (ANC) (N = 3 studies, 3,169 participants) and postnatal care (PNC) (N = 5 studies, 2,462 participants) compared to direct observation. For each study, indicator sensitivity and specificity are presented with 95% confidence intervals. Univariate fixed effects and bivariate random effects models were used to examine whether respondent characteristics (e.g., age group, parity, education level), facility quality, or intervention coverage level influenced the accuracy of women's recall of whether interventions were received. RESULTS: Intervention coverage was associated with reporting accuracy across studies for the majority (9 of 12) of PNC indicators. Increasing intervention coverage was associated with poorer specificity for 8 indicators and improved sensitivity for 6 indicators. Reporting accuracy for ANC or PNC indicators did not consistently differ by any other respondent or facility characteristic. CONCLUSIONS: High intervention coverage may contribute to higher false positive reporting (poorer specificity) among women who receive facility-based maternal and newborn care while low intervention coverage may contribute to false negative reporting (lower sensitivity). While replication in other country and facility settings is warranted, results suggest that monitoring efforts should consider the context of care when interpreting national estimates of intervention coverage.

Measuring implementation outcomes in the context of scaling up possible serious bacterial infection guidelines: Implications for measurement and programs.

BACKGROUND: Reducing the burden of neonatal sepsis requires timely identification and initiation of suitable antibiotic treatment in primary health care (PHC) settings. Countries are encouraged to adopt simplified antibiotic regimens at the PHC level for treating sick young infants (SYI) with signs of possible serious bacterial infection (PSBI). As countries implement PSBI guidelines, more lessons on effective implementation strategies and outcome measurements are needed. We document pragmatic approaches used to design, measure and report implementation strategies and outcomes while adopting PSBI guidelines in Kenya. METHODS: We designed implementation research using longitudinal mixed methods embedded in a continuous regular systematic learning and adoption of evidence in the PHC context. We synthesized formative data to co-create with stakeholders, implementation strategies to incorporate PSBI guidelines into routine service delivery for SYIs. This was followed by quarterly monitoring for learning and feedback on the effect of implementation strategies, documented lessons learned and tracked implementation outcomes. We collected endline data to measure the overall effect on service level outcomes. RESULTS: Our findings show that characterizing implementation strategies and linking them with implementation outcomes, helps illustrate the pathway between the implementation process and outcomes. Although we have demonstrated that it is feasible to implement PSBI in PHC, effective investment in continuous capacity strengthening of providers through blended approaches, efficient use of available human resources, and improving the efficiency of service areas for managing SYIs optimizes timely identification and management of SYI. Sustained provision of commodities for management of SYI facilitates increased uptake of services. Strengthening facility-community linkages supports adherence to scheduled visits. Enhancing the caregiver's preparedness during postnatal contacts in the community or facility will facilitate the effective completion of treatment. CONCLUSION: Careful design, and definition of terms related to the measurement of implementation outcomes and strategies enable ease of interpretation of findings. Using the taxonomy of implementation outcomes help frame the measurement process and provides empirical evidence in a structured way to demonstrate causal relationships between implementation strategies and outcomes. Using this approach, we have illustrated that the implementation of simplified antibiotic regimens for treating SYIs with PSBI in PHC settings is feasible in Kenya.

Validating midwifery professionals' scope of practice and competency: A multi-country study comparing national data to international standards.

BACKGROUND: There is a global shortage of midwives, whose services are essential to meet the healthcare needs of pregnant women and newborns. Evidence suggests that if enough midwives, trained and regulated to global standards, were deployed worldwide, maternal, and perinatal mortality would decline significantly. Health workforce planning estimates the number of midwives needed to achieve population coverage of midwifery interventions. However, to provide a valid measure of midwifery care coverage, an indicator must consider not only the raw number of midwives, but also their scope and competency. The tasks midwives are authorized to deliver and their competency to perform essential skills and behaviors provide crucial information for understanding the availability of safe, high-quality midwifery services. Without reliable estimates for an adequate midwifery workforce, progress toward ending preventable maternal and perinatal mortality will continue to be uneven. The International Labor Organization (ILO) and the International Confederation of Midwives (ICM) suggest standards for midwifery scope of practice and competencies. This paper compares national midwifery regulations, scope, and competencies in three countries to the ILO and ICM standards to validate measures of midwife density. We also assess midwives' self-reported skills/behaviors from the ICM competencies and their acquisition. METHODS AND FINDINGS: We compared midwives' scope of practice in Argentina, Ghana, and India to the ILO Tasks and ICM Essential Competencies for Midwifery Practice. We compared midwives self-reported skills/behaviors with the ICM Competencies. Univariate and bivariate analysis was conducted to describe the association between midwives' skills and selected characteristics. National scopes of practice matched two ILO tasks in Argentina, four in India, and all in Ghana. National standards partially reflected ICM skills in Categories 2, 3, and 4 (pre-pregnancy and antenatal care; care during labor and birth; and ongoing care of women and newborns, respectively) in Argentina (range 11% to 67%), mostly in India (range 74% to 100%) and completely in Ghana (100% match). 1,266 midwives surveyed reported considerable variation in competency for skills and behaviors across ICM Category 2, 3, and 4. Most midwives reported matching skills and behaviors around labor and childbirth (Category 2). Higher proportions of midwives reported gaining basic skills through in-service training and on-job-experience than in pre-service training. CONCLUSION: Estimating the density of midwives needed for an adequate midwifery workforce capable of providing effective population coverage is predicated on a valid numerator. A reliable and valid count of midwives to meet population needs assumes that each midwife counted has the authority to exercise the same behaviors and reflects the ability to perform them with comparable competency. Our results demonstrate variation in midwifery scopes of practice and self-reported competencies in comparison to global standards that pose a threat to the reliability and validity of the numerator in measures of midwife density, and suggest the potential for expanded authorization and improved education and training to meet global reference standards for midwifery practice has not been fully realized. Although the universally recognized standard, this study demonstrates that the complex, composite descriptions of skills and behaviors in the ICM competencies make them difficult to use as benchmark measures with any precision, as they are not defined or structured to serve as valid measures for assessing workforce competency. A simplified, content-validated measurement system is needed to facilitate evaluation of the competency of the midwifery workforce.

Prevention and Screening for Cardiometabolic Disease Following Hypertensive Disorders in Pregnancy in Low-Resource Settings: A Systematic Review and Delphi Study.

Hypertensive disorders in pregnancy (HDP) and cardiometabolic and kidney diseases are rising in low- and middle-income countries (LMICs). While HDP are risk factors for cardiometabolic and kidney diseases, cost-effective, scalable strategies for screening and prevention in women with a history of HDP are lacking. Existing guidelines and recommendations require adaptation to LMIC settings. This article aims to generate consensus-based recommendations for the prevention and screening of cardiometabolic and kidney diseases tailored for implementation in LMICs. We conducted a systematic review of guidelines and recommendations for prevention and screening strategies for cardiometabolic and chronic kidney diseases following HDP. We searched PubMed/Medline, Embase and Cochrane Library for relevant articles and guidelines published from 2010 to 2021 from both high-income countries (HICs) and LMICs. No other filters were applied. References of included articles were also assessed for eligibility. Findings were synthesized narratively. The summary of guiding recommendations was subjected to two rounds of Delphi consensus surveys with experts experienced in LMIC settings. Fifty-four articles and 9 guidelines were identified, of which 25 were included. Thirty-five clinical recommendations were synthesized from these and classified into six domains: identification of women with HDP (4 recommendations), timing of first counseling and provision of health education (2 recommendations), structure and care setting (12 recommendations), information and communication needs (5 recommendations), cardiometabolic biomarkers (8 recommendations) and biomarkers thresholds (4 recommendations). The Delphi panel reached consensus on 33 final recommendations. These recommendations for health workers in LMICs provide practical and scalable approaches for effective screening and prevention of cardiometabolic disease following HDP. Monitoring and evaluation of implementation of these recommendations provide opportunities for reducing the escalating burden of noncommunicable diseases in LMICs.

Institutionalizing the Management of Sick Young Infants: Kenya's Experience in Revising National Guidelines on Integrated Management of Newborn and Childhood Illnesses.

INTRODUCTION: In 2015, the World Health Organization (WHO) developed guidelines for the management of sick young infants (SYIs) with possible serious bacterial infection (PSBI) where referral is not feasible. The Ponya Mtoto project was designed as an implementation research project to demonstrate how to adopt the WHO PSBI guidelines in the Kenyan context. PONYA MTOTO PROJECT DESCRIPTION: Between October 2017 and June 2021, Ponya Mtoto was implemented in 4 Kenyan counties with higher infant and newborn mortality rates than the national mean. A total of 48 health facilities stratified by level of services were selected as study sites. IMPLEMENTATION APPROACH: The following activities were done to institutionalize the management of SYIs with PSBI where referral is not feasible in Kenya's health system: (1) participating in a cocreation workshop and development of a theory of change; (2) revising the national integrated management of newborn and childhood illnesses guidelines to incorporate the management of PSBI where referral is not feasible; (3) improving availability of essential commodities; (4) strengthening provider confidence in the management of SYIs; (5) strengthening awareness about PSBI services for SYIs at the community level; and (6) harmonizing the national integrated management of newborn and childhood illnesses guidelines to address discrepancies in the content on the management of PSBI. In addition, the project focused on strengthening quality of care for SYIs and using implementation research to track progress in achieving project targets and outcomes. CONCLUSION: Using an implementation research approach to introduce new WHO guidelines on PSBI where referral is not feasible into Kenya's health care service was critical to fostering engagement of a diverse range of stakeholders, monitoring provider skills and confidence-building, strengthening provision of key commodities for managing SYIs with PSBI, and sustaining community-facility linkages.

Acipimox in Mitochondrial Myopathy (AIMM): study protocol for a randomised, double-blinded, placebo-controlled, adaptive design trial of the efficacy of acipimox in adult patients with mitochondrial myopathy.

BACKGROUND: Mitochondrial disease is a heterogenous group of rare, complex neurometabolic disorders. Despite their individual rarity, collectively mitochondrial diseases represent the most common cause of inherited metabolic disorders in the UK; they affect 1 in every 4300 individuals, up to 15,000 adults (and a similar number of children) in the UK. Mitochondrial disease manifests multisystem and isolated organ involvement, commonly affecting those tissues with high energy demands, such as skeletal muscle. Myopathy manifesting as fatigue, muscle weakness and exercise intolerance is common and debilitating in patients with mitochondrial disease. Currently, there are no effective licensed treatments and consequently, there is an urgent clinical need to find an effective drug therapy. AIM: To investigate the efficacy of 12-week treatment with acipimox on the adenosine triphosphate (ATP) content of skeletal muscle in patients with mitochondrial disease and myopathy. METHODS: AIMM is a single-centre, double blind, placebo-controlled, adaptive designed trial, evaluating the efficacy of 12 weeks' administration of acipimox on skeletal muscle ATP content in patients with mitochondrial myopathy. Eligible patients will receive the trial investigational medicinal product (IMP), either acipimox or matched placebo. Participants will also be prescribed low dose aspirin as a non-investigational medical product (nIMP) in order to protect the blinding of the treatment assignment. Eighty to 120 participants will be recruited as required, with an interim analysis for sample size re-estimation and futility assessment being undertaken once the primary outcome for 50 participants has been obtained. Randomisation will be on a 1:1 basis, stratified by Fatigue Impact Scale (FIS) (dichotomised as < 40, ≥ 40). Participants will take part in the trial for up to 20 weeks, from screening visits through to follow-up at 16 weeks post randomisation. The primary outcome of change in ATP content in skeletal muscle and secondary outcomes relating to quality of life, perceived fatigue, disease burden, limb function, balance and walking, skeletal muscle analysis and symptom-limited cardiopulmonary fitness (optional) will be assessed between baseline and 12 weeks. DISCUSSION: The AIMM trial will investigate the effect of acipimox on modulating muscle ATP content and whether it can be repurposed as a new treatment for mitochondrial disease with myopathy. TRIAL REGISTRATION: EudraCT2018-002721-29 . Registered on 24 December 2018, ISRCTN 12895613. Registered on 03 January 2019, https://www.isrctn.com/search?q=aimm.

Examining Roles, Support, and Experiences of Community Health Workers During the COVID-19 Pandemic in Bangladesh: A Mixed Methods Study.

INTRODUCTION: Understanding community health workers' (CHWs) experiences of sustaining routine health care promotion and provision activities as well as their challenges in adopting new responsibilities within a dynamic context is critical. This study explored the roles and perspectives of CHWs within the government-led coronavirus disease (COVID-19) community health response in Bangladesh. METHODS: We conducted a mixed methods study to explore the government's response to COVID-19 and its association with community health programming through a telephone-based survey of 370 government-employed CHWs. We also conducted 28 in-depth interviews with policy makers, program managers, CHW supervisors, and CHWs. We conducted exploratory and regression analysis of survey data and qualitative analysis of interview data. RESULTS: The majority of CHWs reported receiving training related to COVID-19, including community-based prevention strategies from government and nongovernment stakeholders. Access to infection prevention supplies differed significantly by CHW cadre, and perspectives on the provision of adequate supplies varied qualitatively. CHWs reported slight decreases in routine work across all health areas early in the pandemic, and a majority reported added COVID-19-related responsibilities as the pandemic continued, including advising on signs/symptoms in their communities and referring suspected cases of COVID-19 for advanced facility care. Regression analyses showed that government support and integration of CHWs into their response-particularly being trained on COVID-19-predicted CHW capacity to advise communities on symptoms and provide routine services. DISCUSSION: Government-employed CHWs in Bangladesh continued to provide health education and routine services in their communities despite pandemic- and response-related challenges. Varied support and differential CHW cadre-specific effects on COVID-19 awareness building in the community, referral, and routine service provision merit attention in Bangladesh's pluralistic community health system. While COVID-19 infection and government-mandated lockdowns restricted CHW mobility, the workers' capacity to continue service provision and education can be leveraged in vaccination and surveillance efforts moving forward.

Experience of care of hospitalized newborns and young children and their parents: A scoping review.

INTRODUCTION: Several global initiatives put parent involvement at the forefront of enabling children's well-being and development and to promote quality of care for newborns and hospitalized young children aged 0-24 months. Scanty evidence on mistreatment such as delays or neglect and poor pain management among newborns exists, with even less exploring the experience of their parents and their hospitalized young children. To address this gap, authors reviewed research on experience of care for hospitalized young children and their parents, and potential interventions that may promote positive experience of care. METHODS: A scoping review of English language articles, guidelines, and reports that addressed the experiences of care for newborns and sick young children 0-24 months in health facilities was conducted. Multiple databases: PubMed, PROSPERO, COCHRANE Library and Google Scholar were included and yielded 7,784 articles. Documents published between 2009 and November 2020, in English and with evidence on interventions that addressed family involvement and partnership in care for their sick children were included. RESULTS: The scoping review includes 68 documents across 31 countries after exclusion. Mistreatment of newborns comprises physical abuse, verbal abuse, stigma and discrimination, failure to meet professional standards, poor rapport between providers and patients, poor legal accountability, and poor bereavement and posthumous care. No literature was identified describing mistreatment of hospitalized children aged 60 days- 24 months. Key drivers of mistreatment include under-resourced health systems and poor provider attitudes. Positive experience of care was reported in contexts of good parent-provider communication. Three possible interventions on positive experience of care for hospitalized young children (0-24 months) emerged: 1) nurturing care; 2) family centered care and 3) provider and parental engagement. Communication and counseling, effective provider-parental engagement, and supportive work environments were associated with reduced anxiety and stress for parents and hospitalized young children. Few interventions focused on addressing providers' underlying attitudes and biases that influence provider behaviors, and how they affect engaging with parents. CONCLUSION: Limited evidence on manifestations of mistreatment, lack of respectful care, drivers of poor experience and interventions that may mitigate poor experience of care for hospitalized young children 0-24 months especially in low resource settings exists. Design and testing appropriate models that enhance socio-behavioral dimensions of care experience and promote provider-family engagement in hospitals are required.

Exploring awareness of obstetric fistula in Eastern and Northern Nigeria: perceived causes, symptoms, and availability of treatment services.

BACKGROUND: Evidence suggests that there are approximately two female genital fistula cases per 1000 women of reproductive age in sub-Saharan Africa. It is estimated that more than 200,000 women are affected by fistula in Nigeria, primarily due to obstetric causes. Awareness has been indicated as a risk factor for the development of obstetric fistula. This study explored the awareness of obstetric fistula such as causes, symptoms, and availability of and access to treatment services in southeastern and northwestern Nigeria. METHODS: An exploratory qualitative study design was used to conduct this research in Kano and Ebonyi states in northern and eastern Nigeria, respectively. A total of six (6) focus group discussions were conducted with three categories of participants: women who were successfully repaired and discharged (n = 2), community-married men (n = 2), and women (n = 2). Forty-four (44) In-depth interviews were conducted three categories of participants: 18 with women with fistula who were either awaiting repair or had been repaired; 6 family member caregivers accompanying fistula patients, and 20 health service providers at fistula repair centers. We developed a data analysis plan based on the emerging themes. The transcripts and field notes were imported into QSR Nvivo version 11 and coded accordingly. Content and thematic analysis was run by inductively drawing themes based on the elicited information from participants. RESULTS: There was lack of knowledge of obstetric fistula and its causes among married men and women in the community, caregivers, and some patients were unaware of what caused their fistula for years. In this study, none of the community men and women nor caregivers correctly identified the causes and symptoms of a fistula or knew where to seek treatment. Knowledge about fistula was more common among women who had undergone repairs. Some repaired women attributed the cause of fistula to the providers who attended to them during delivery. CONCLUSIONS: Findings reveal a widespread lack of awareness of obstetric fistula onset and awareness of the availability of repair services at the community level. There is an urgent need to explore multi-pronged strategies for increasing awareness of obstetric fistula and available treatment services among women and other community members.

Perceptions and predictors of respectful maternity care in Malawi: A quantitative cross-sectional analysis.

OBJECTIVE: Access to high-quality, respectful care is a basic human right. A lack of respectful care during childbirth is associated with poor outcomes and can negatively influence care-seeking and maternal mental health. We aimed to describe how women perceive their experience of maternity care in Malawi. METHODS: We implemented a cross-sectional survey of women (n = 660) who delivered in 25 birth facilities in four districts in Malawi in March 2020 using a validated 30-item, 90-point person-centered maternity care (PCMC) scale. We used descriptive statistics to examine women's experience of care and analyzed bivariable and multivariable mixed-effects models to evaluate predictors of PCMC. Statistical models accounted for clustering of women at the facility level and included maternal age, marital status, education, parity, mother or infant complications, timing of antenatal care (ANC), provider cadre and gender, facility type and sector, and district. RESULTS: Mean PCMC score was 57.5 (range 21-84), with the lowest score (12.4 of 27 points) in communication and autonomy. Women reported: being prohibited from having a birth companion during labor (49.4%) or delivery (60.3%); providers did not introduce themselves (81.1%); providers did not ask consent before procedures/examinations (42.4%); women felt they could not ask questions (40.9%); and were not involved in care decisions (61.5%). Few women reported being frequently abused physically (2%) or verbally (3.5%); almost all had water/electricity available (>95%). In bivariate analyses, statistically significant positive associations were found between PCMC score and early ANC, male accompaniment to the facility, male provider, and a lack of complications; all associations remained at least potentially statistically significant in multivariable modeling. CONCLUSIONS: Physical and verbal abuse and a lack of basic amenities were rare, while a lack of communication with patients and social support were common. Maternal characteristics (like timing of ANC and maternal or newborn complications) were predictors of RMC, while facility/system factors, like facility type and sector, were not. Continued efforts to improve respectful care will require strengthening provider communication skills and encouraging patient and companion involvement in care.

Determining a Trusting Environment for Maternity Care: A Framework Based on Perspectives of Women, Communities, Service Providers, and Managers in Peri-Urban Kenya.

Trust in health service providers and facilities is integral to health systems accountability. Understanding determinants of trust, a relational construct, in maternity settings necessitates exploring hierarchical perspectives of users, providers, and influencers in the care environment. We used a theoretically driven qualitative approach to explore trust determinants in a maternity setting across patient-provider, inter-provider, and community-policymaker interactions and relationships in peri-urban Kenya. Focus groups (n = 8, N = 70) with women who recently gave birth (WRB), pregnant women, and male partners, and in-depth-interviews (n = 33) with WRB, health care providers and managers, and community health workers (CHWs) were conducted in 2013, soon after the national government's March 2013 introduction of a policy mandate for "Free Maternity Care." We used thematic coding, memo writing, and cross-perspective triangulation to develop a multi-faceted trust determinants framework. We found that determinants of trust in a maternity setting can be broadly classified into six types of factors, where each type of factor represents a cluster of determinants that may each positively or negatively influence trust: patient, provider, health facility, community, accountability, and structural. Patient factors are prior experiences, perceived risks and harms, childbirth outcomes, and maternal health literacy. Provider factors are empathy and respect, responsiveness, and perceived capability of providers. Health facility factors are "good services" as perceived by patients, physical environment, process navigability, provider collaboration and oversight, discrimination, and corruption. Community factors are facility reputation and history, information channels, and maternal health literacy. Accountability factors are alignment of actions with expectations, adaptations to policy changes, and voice and feedback. Structural factors are institutional hierarchies and policies in the form of professional codes. Trust determinants are complex, nuanced and reflect power dynamics across relationships. Findings offer insight into socio-political maternity norms and demand a more equitable care interface between users and providers.

Understanding Factors That Support Community Health Worker Motivation, Job Satisfaction, and Performance in Three Ugandan Districts: Opportunities for Strengthening Uganda's Community Health Worker Program.

BACKGROUND: Uganda's community health worker (CHW) program experiences several challenges related to the appropriate motivation, job satisfaction, and performance of the CHW workforce. This study aims to identify barriers in the effective implementation of financial and non-financial incentives to support CHWs and to strengthen Uganda's CHW program. METHODS: The study was implemented in Uganda's Lira, Wakiso, and Mayuge districts in May 2019. Ten focus group discussions (FGDs) were held with 91 CHWs, 17 in-depth interviews (IDIs) were held with CHW supervisors, and 7 IDIs were held with policy-level stakeholders. Participants included stakeholders from both the Ugandan government and non-governmental organizations (NGOs). Utilizing a thematic approach, themes around motivation, job satisfaction, incentive preferences, and CHW relationships with the community, healthcare facilities, and government were analyzed. RESULTS: CHWs identified a range of factors that contributed to their motivation or demotivation. Non-monetary factors included recognition from the health system and community, access to transportation, methods for identification as a healthcare worker, provision of working tools, and training opportunities. Monetary factors included access to monthly stipends, transportation-related refunds, and timely payment systems to reduce refund delays to CHWs. Additionally, CHWs indicated wanting to be considered for recruitment into the now-halted rollout of a salaried CHW cadre, given the provision of payment. CONCLUSION: It is imperative to consider how to best support the current CHW program prior to the introduction of new cadres, as it can serve to exacerbate tensions between cadres and further undermine provision of community health. Providing a harmonized, balanced, and uniform combination of both monetary incentives with non-monetary incentives is vital for effective CHW programs.