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Background: Hepatitis B infection is a significant global health threat contributing to healthcare worker (HCW) harm, threatening already precarious health systems. Aim: To document self-reported hepatitis B vaccination history and serology results. Setting: A select group of high-risk HCWs in a tertiary care hospital in Banjul, the Gambia. Methods: This was a cross-sectional pilot study conducted from 12 June 2023 to 16 June 2023. Participants were HCWs at high risk for blood exposure who completed a health history interview prior to serology testing for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) and vaccination. Results: The pilot study enrolled 70 HCWs who were primarily female (n = 44; 62.9%). The majority of the participants, 43 (61.4%) reported having received at least one dose of the hepatitis B vaccine in the past. The overall prevalence of HBsAg positivity in this study was 4.3% (95% confidence interval [CI]: 1.5–11.9), all in older participants. Importantly, 60.0% (95% CI: 48.3–70.7) of participants had no anti-HBs detected. Conclusion: This pilot study documents a higher prevalence of hepatitis B infection among older workers and the lack of anti-HBs across the majority of participants. This suggests a serious vulnerability for the individual health worker and indicates the need for a wider screening and vaccination campaign to assess the risk across the Gambian health workforce. Contribution: This pilot study provides the first evidence to support a wider assessment of hepatitis B serology status of Gambian health workers to gauge the need for a broader vaccine campaign.

Osteosarcoma is a common neoplastic condition of the bone mostly affecting the appendicular bones in dogs. A five-year-old female Rottweiler was presented with a swollen left hind limb. Haematology showed mild nonregenerative anaemia, severe leukocytosis, and moderate neutrophilia without left shift, monocytosis, and severe lymphopenia. Fine needle aspirate (FNA) cytology revealed oval to spindle cells with marked cellular pleomorphism, anisocytosis, binucleation, and proteinaceous granules in the background while radiographic examination revealed osteolysis of the tibia and fibular with new bone formation. These findings are consistent with osteosarcoma. A diagnosis of osteosarcoma was made, based on the cytology and radiography. Surgical amputation of the complete left limb was carried out. However, the dog died of leptospirosis one month later. Post mortem examination revealed pulmonary metastasis of the osteosarcoma. Histopathology of the limb growth revealed oval to spindle cells with intracytoplasmic eosinophilic materials and osteoid matrix. Diagnosis and treatment of dogs affected by osteosarcoma should be comprehensive and complete, with adequate follow-up. The marked lymphopenia could be associated with poor prognosis, therefore an index for prognosis in osteosarcoma. The mortality, in this case, could have been related to leptospirosis and associated with the immunosuppression from tumour metastasis. [ABSTRACT FROM AUTHOR]

Abstract Background Diarrhoeal disease remains a significant cause of morbidity and mortality among the under-fives in many low- and middle-income countries. Changes to food safety practices and feeding methods around the weaning period, alongside improved nutrition, may significantly reduce the risk of disease and improve development for infants. We describe a protocol for a cluster randomised trial to evaluate the effectiveness of a multi-faceted community-based educational intervention that aims to improve food safety and hygiene behaviours and enhance child nutrition. Methods We describe a mixed-methods, parallel group, two-arm, superiority cluster randomised controlled trial with baseline measures. One hundred twenty clusters comprising small urban and rural communities will be recruited in equal numbers and randomly allocated in a 1:1 ratio to either treatment or control arms. The community intervention will be focussed around an ideal mother concept involving all community members during campaign days with dramatic arts and pledging, and follow-up home visits. Participants will be mother–child dyads (27 per cluster period) with children aged 6 to 36 months. Data collection will comprise a day of observation and interviews with each participating mother–child pair and will take place at baseline and 4 and 15 months post-intervention. The primary analysis will estimate the effectiveness of the intervention on changes to complementary-food safety and preparation behaviours, food and water contamination, and diarrhoea. Secondary outcomes include maternal autonomy, enteric infection, nutrition, child anthropometry, and development scores. A additional structural equation analysis will be conducted to examine the causal relationships between the different outcomes. Qualitative and health economic analyses including process evaluation will be done. Conclusions The trial will provide evidence on the effectiveness of community-based behavioural change interventions designed to reduce the burden of diarrhoeal disease in the under-fives and how effectiveness varies across different contexts. Trial registration ISRCTN14390796. Registration date December 13, 2021

Summary: Background: COVID-19, caused by SARS-CoV-2, is one of the deadliest pandemics of the past 100 years. Genomic sequencing has an important role in monitoring of the evolution of the virus, including the detection of new viral variants. We aimed to describe the genomic epidemiology of SARS-CoV-2 infections in The Gambia. Methods: Nasopharyngeal or oropharyngeal swabs collected from people with suspected cases of COVID-19 and international travellers were tested for SARS-CoV-2 with standard RT-PCR methods. SARS-CoV-2-positive samples were sequenced according to standard library preparation and sequencing protocols. Bioinformatic analysis was done using ARTIC pipelines and Pangolin was used to assign lineages. To construct phylogenetic trees, sequences were first stratified into different COVID-19 waves (waves 1–4) and aligned. Clustering analysis was done and phylogenetic trees constructed. Findings: Between March, 2020, and January, 2022, 11 911 confirmed cases of COVID-19 were recorded in The Gambia, and 1638 SARS-CoV-2 genomes were sequenced. Cases were broadly distributed into four waves, with more cases during the waves that coincided with the rainy season (July–October). Each wave occurred after the introduction of new viral variants or lineages, or both, generally those already established in Europe or in other African countries. Local transmission was higher during the first and third waves (ie, those that corresponded with the rainy season), in which the B.1.416 lineage and delta (AY.34.1) were dominant, respectively. The second wave was driven by the alpha and eta variants and the B.1.1.420 lineage. The fourth wave was driven by the omicron variant and was predominantly associated with the BA.1.1 lineage. Interpretation: More cases of SARS-CoV-2 infection were recorded in The Gambia during peaks of the pandemic that coincided with the rainy season, in line with transmission patterns for other respiratory viruses. The introduction of new lineages or variants preceded epidemic waves, highlighting the importance of implementing well structured genomic surveillance at a national level to detect and monitor emerging and circulating variants. Funding: Medical Research Unit The Gambia at London School of Hygiene & Tropical Medicine, UK Research and Innovation, WHO.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is evolving differently in Africa than in other regions. Africa has lower SARS-CoV-2 transmission rates and milder clinical manifestations. Detailed SARS-CoV-2 epidemiologic data are needed in Africa. We used publicly available data to calculate SARS-CoV-2 infections per 1,000 persons in The Gambia. We evaluated transmission rates among 1,366 employees of the Medical Research Council Unit The Gambia (MRCG), where systematic surveillance of symptomatic cases and contact tracing were implemented. By September 30, 2020, The Gambia had identified 3,579 SARS-CoV-2 cases, including 115 deaths; 67% of cases were identified in August. Among infections, MRCG staff accounted for 191 cases; all were asymptomatic or mild. The cumulative incidence rate among nonclinical MRCG staff was 124 infections/1,000 persons, which is >80-fold higher than estimates of diagnosed cases among the population. Systematic surveillance and seroepidemiologic surveys are needed to clarify the extent of SARS-CoV-2 transmission in Africa.

BackgroundThe Gambia has high rates of under-5 mortality from diarrhoea and pneumonia, peaking during complementary-feeding age. Community-based interventions may reduce complementary-food contamination and disease rates.Methods and findingsA public health intervention using critical control points and motivational drivers, delivered February-April 2015 in The Gambia, was evaluated in a cluster randomised controlled trial at 6- and 32-month follow-up in September-October 2015 and October-December 2017, respectively. After consent for trial participation and baseline data were collected, 30 villages (clusters) were randomly assigned to intervention or control, stratified by population size and geography. The intervention included a community-wide campaign on days 1, 2, 17, and 25, a reminder visit at 5 months, plus informal community-volunteer home visits. It promoted 5 key complementary-food and 1 key drinking-water safety and hygiene behaviours through performing arts, public meetings, and certifications delivered by a team from local health and village structures to all villagers who attended the activities, to which mothers of 6- to 24-month-old children were specifically invited. Control villages received a 1-day campaign on domestic-garden water use. The background characteristics of mother and clusters (villages) were balanced between the trial arms. Outcomes were measured at 6 and 32 months in a random sample of 21-26 mothers per cluster. There were no intervention or research team visits to villages between 6 and 32 months. The primary outcome was a composite outcome of the number of times key complementary-food behaviours were observed as a proportion of the number of opportunities to perform the behaviours during the observation period at 6 months. Secondary outcomes included the rate of each recommended behaviour; microbiological growth from complementary food and drinking water (6 months only); and reported acute respiratory infections, diarrhoea, and diarrhoea hospitalisation. Analysis was by intention-to-treat analysis adjusted by clustering. (Registration: PACTR201410000859336). We found that 394/571 (69%) of mothers with complementary-feeding children in the intervention villages were actively involved in the campaign. No villages withdrew, and there were no changes in the implementation of the intervention. The intervention improved behaviour adoption significantly. For the primary outcome, the rate was 662/4,351(incidence rate [IR] = 0.15) in control villages versus 2,861/4,378 (IR = 0.65) in intervention villages (adjusted incidence rate ratio [aIRR] = 4.44, 95% CI 3.62-5.44, p < 0.001), and at 32 months the aIRR was 1.17 (95% CI 1.07-1.29, p = 0.001). Secondary health outcomes also improved with the intervention: (1) mother-reported diarrhoea at 6 months, with adjusted relative risk (aRR) = 0.39 (95% CI 0.32-0.48, p < 0.001), and at 32 months, with aRR = 0.68 (95% CI 0.48-0.96, p = 0.027); (2) mother-reported diarrhoea hospitalisation at 6 months, with aRR = 0.35 (95% CI 0.19-0.66, p = 0.001), and at 32 months, with aRR = 0.38 (95% CI 0.18-0.80, p = 0.011); and (3) mother-reported acute respiratory tract infections at 6 months, with aRR = 0.67 (95% CI 0.53-0.86, p = 0.001), though at 32 months improvement was not significant (p = 0.200). No adverse events were reported. The main limitations were that only medium to small rural villages were involved. Obtaining laboratory cultures from food at 32 months was not possible, and no stool microorganisms were investigated.ConclusionsWe found that low-cost and culturally embedded behaviour change interventions were acceptable to communities and led to short- and long-term improvements in complementary-food safety and hygiene practices, and reported diarrhoea and acute respiratory tract infections.Trial registrationThe trial was registered on the 17th October 2014 with the Pan African Clinical Trial Registry in South Africa with number (PACTR201410000859336) and 32-month follow-up as an amendment to the trial.

The importance of skilled attendance at delivery, as reflected in the MDG 5, is being promoted in developing countries to address the high maternal/perinatal morbidity and mortality. Evaluation of personnel skills and availability of material resources are central to elimination of barriers to delivery of basic Emergency Obstetric Care (EOC) to the community. We designed a semi-structured, interviewee-administered questionnaire for 54 certified Nurse-Midwives working in Primary Health Care (PHC) clinics in Nasarawa State, central Nigeria, and examined their knowledge and competencies in the five major areas responsible for maternal mortality in sub- Saharan Africa, including power supply, referral linkages and motivation to work. Majority 51 (94.4%) of PHCs neither used the Partograph nor performed manual vacuum aspiration. Referral systems and feedback mechanisms were practically non-existent, 38 (70.4%) of facilities were >5km from the nearest referral centre, with 14(29.5%) connected to the national grid. Majority (68.5%) of respondents would want to work abroad. The quality of skilled attendance is low and basic EOC facilities are lacking, a situation further threatened by potential emigration to greener pastures. Governments and development partners need to address facility and skilled manpower shortages in developing countries to make a modest attempt at meeting the MDG on maternal health. [ABSTRACT FROM AUTHOR]

Introduction: Incorporating shared decision-making (SDM) with children and families in hospitals was a top priority identified by patients, caregivers, and clinicians. Bronchiolitis, a common and costly reason for hospitalization in children, is an exemplar condition to study SDM in hospitals. Internationally, clinical practice guidelines differ when recommending intravenous (IV or parenteral) or nasogastric (NG or enteral) fluids for hospitalized infants with bronchiolitis who are unsafe to be fed orally. While evidence indicates that either IV or NG fluids are safe and effective, parent involvement in SDM in selecting IV or NG fluids is unknown. Our aim is to generate knowledge of SDM with parents in choosing between IV or NG fluids and the benefits and harms of these two treatment options for hospitalized children with bronchiolitis., Method: This is a multicenter, prospective, observational study, including children aged <12 months admitted to hospital with bronchiolitis requiring supplemental IV or NG fluids. The primary outcome will evaluate the extent of SDM in choosing IV versus NG fluids using the validated CollaboRATE tool. Secondary outcomes include the proportion of parents provided a choice of IV versus NG fluids; parent knowledge of fluid therapy; rate of fluids; length of hospital stay; and complications., Discussion: This study will evaluate the extent of SDM in hospitalized infants with bronchiolitis who require IV or NG fluids and will evaluate both patient-centered and clinical outcomes that are relevant to clinical practice., (© 2024 The Author(s). Journal of Hospital Medicine published by Wiley Periodicals LLC on behalf of Society of Hospital Medicine.)

Background: Despite stewardship efforts, laboratory testing overuse persists across medicine., Objectives: To understand laboratory stewardship perceptions and testing patterns at a tertiary care pediatric hospital so that we could identify potential improvement opportunities., Methods: An electronic survey exploring laboratory stewardship was sent to all pediatric medicine resident and staff physicians. Laboratory testing data were also assessed for patterns of testing and overuse., Results: The survey response rate was 54% (43/80). The results indicated good familiarity with stewardship but poor familiarity with testing specifics (eg, cost). A mobile reference application was the most preferred quality improvement intervention, and online modules were the least desired. Overuse was apparent, with as many as 53% of laboratory tests being repeated within 7 days and only half of repeated tests subsequently yielding abnormal results., Conclusions: Altogether, the data we collated demonstrated poor understanding of laboratory stewardship and substantial repeat testing with few abnormal results. These study findings suggest that laboratory stewardship is lacking at our center, and that multiple improvement opportunities exist., (© The Author(s) 2024. Published by Oxford University Press on behalf of American Society for Clinical Pathology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Objectives: We examined trends in patient volumes and care intensity among children admitted with laboratory-confirmed respiratory viral infections over 5 years in Ottawa, following the most recent and intense respiratory viral season experienced throughout the Ontario paediatric health system., Methods: This was a retrospective cohort study of patients at the Children's Hospital of Eastern Ontario (CHEO) in Ottawa, who were diagnosed with a laboratory-confirmed respiratory viral infection in the first 72 h of admission between October 22, 2017 and March 25, 2023. Their admissions were stratified by age groups and level of care intensity, based on unit of admission and/or additional ventilatory needs, with Level 3 patients requiring intensive care unit admission, and evaluated for trends over six surveillance periods that began in Week 35 (early September) and ended in Week 34 (end-August) of the following year., Results: During the surveillance period from August 28, 2022 to March 25, 2023, there was an early, steep and twofold increase in admissions due to respiratory viral infections compared to previous periods, driven largely by Respiratory Syncytial Virus and Influenza A. Despite similar age distributions, there was a larger volume of Level 2 and 3 admissions, and higher proportion of patients requiring Level 2 care intensity in inpatient medicine units (23.4% versus 10.4% in pre-pandemic years; P < 0.001)., Conclusions: The most recent viral season was associated with elevated volumes and higher inpatient acuity compared to previous years and underscores the need for additional operational and human health resources to support paediatric health systems through these predictable surge periods., Competing Interests: All authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Canadian Paediatric Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: The use of virtual care has increased dramatically in response to the COVID-19 pandemic, yet evidence is lacking regarding the impact of virtual care on patient outcomes, particularly in pediatrics. A standardized evaluation approach is required to support the integration of virtual care into pediatric health care delivery programs. The objective of this work was to develop a comprehensive and structured framework for pediatric virtual care evaluation. This framework is intended to engage and guide care providers, health centres, and stakeholders towards the development of a standardized approach to the evaluation of pediatric virtual care., Methods: We brought together a diverse multidisciplinary team, including pediatric clinicians, researchers, digital health leads and analysts, program leaders, a human factors engineer, a family advisor and our manager of health equity and diversity. The team reviewed the literature, including published evaluation frameworks, and used a consensus-based method to develop a virtual care evaluation framework applicable to a broad spectrum of pediatric virtual care programs. We used an iterative process to develop framework components, including domains and sub-domains, examples of evaluation questions, measures, and data sources. Team members met repeatedly over seven months to generate and provide feedback on all components of the framework, making revision as needed until consensus was reached. The framework was then applied to an existing virtual care program., Results: The resulting framework includes four domains (health outcomes, health delivery, individual experience, and program implementation) and 19 sub-domains designed to support the development and evaluation of pediatric virtual care programs. We also developed guidance on how to use the framework and illustrate its utility by applying it to an existing pediatric virtual care program., Conclusions: This virtual care evaluation framework expands on previously developed frameworks by providing additional detail and a structure that supports practical application. It can be used to evaluate a wide range of pediatric virtual care programs in a standardized manner. Use of this comprehensive yet easy to use evaluation framework will inform appropriate implementation and integration of virtual care into routine practice and support its sustainability and continuous improvement., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Family-centered rounds (FCR) are fundamental to pediatric inpatient care. During the COVID-19 pandemic, we aimed to design and implement a virtual family-centered rounds (vFCR) process that allowed continuation of inpatient rounds while following physical distancing guidelines and preserving personal protective equipment (PPE)., Methods: A multidisciplinary team developed the vFCR process using a participatory design approach. From April through July 2020, quality improvement methods were used to iteratively evaluate and improve the process. Outcome measures included satisfaction, perceived effectiveness, and perceived usefulness of vFCR. Data were collected via questionnaire distributed to patients, families, staff and medical staff, and analyzed using descriptive statistics and content analysis. Virtual auditors monitored time per patient round and transition time between patients as balancing measures., Results: Seventy-four percent (51/69) of health care providers surveyed and 79% (26/33) of patients and families were satisfied or very satisfied with vFCR. Eighty eight percent (61/69) of health care providers and 88% (29/33) of patients and families felt vFCR were useful. Audits revealed an average vFCR duration of 8.4 min (SD = 3.9) for a single patient round and transition time between patients averaged 2.9 min (SD = 2.6)., Conclusion: Virtual family-centered rounds are an acceptable alternative to in-person FCR in a pandemic scenario, yielding high levels of stakeholder satisfaction and support. We believe vFCR are a useful method to support inpatient rounds, physical distancing, and preservation of PPE that may also be valuable beyond the pandemic. A rigorous process evaluation of vFCR is underway., (© 2023. Crown.)

Background/purpose: Despite widespread use of Electronic Health Records (EHR), the promise of benefits has not been clearly realised due, in part, to inadequate physician training. Training for EHR use is a highly complex intervention that occurs in a dynamic socio-technical health system. The purpose of this study was to describe and critically assess the interplay between educational activities and organisational factors that influenced EHR training and implementation across two different hospitals., Methods: Based in a socio-technical framework, a comparative qualitative case study was undertaken as well suited to real-world processes. Semi-structured interviews were completed (n = 43), representing administrative leaders, staff physicians, residents and EHR trainers from two Canadian academic hospitals. Thematic analysis was employed for analysis., Results: Similar findings were noted at both hospitals despite different implementation strategies. Despite mandatory training, physicians described limited transferability of training to the workplace. Factors contributing to this included standardised vendor modules (lacking specificity for their clinical context); variable EHR trainer expertise; limited post-launch training; and insufficient preparation for changes to workflow. They described learning while caring for patients and using workarounds. Strong emotional responses were described, including anger, frustration, anxiety and fear of harming patients., Conclusions: Training physicians for effective EHR utilisation requires organisational culture transformation as EHRs impacts all aspects of clinical workflows. Analytic thinking to consider workflows, ongoing post-launch training and the recognition of the interdependency of multiple factors are critical to preparing physicians to provide effective clinical care, and potentially reducing burnout. A list of key considerations is provided for educational leaders., (© 2022 Association for the Study of Medical Education and John Wiley & Sons Ltd.)

Health care systems and providers have rapidly adapted to virtual care delivery during this unprecedented time. Clinical programs initiated a variety of virtual care delivery models to maintain access to care, preserve personal protective equipment, and minimize infectious disease spread. Herein, we first describe the context within paediatric health delivery during the COVID-19 pandemic in Canada that fueled the rise of virtual care delivery. We then summarize the development, implementation, and beneficial impact of the innovative virtual care delivery programs currently in use at Children's Hospital of Eastern Ontario (CHEO) for both inpatient and outpatient care, specifically in our ambulatory clinics, emergency department, and mental health program. We highlight the transferable unique ways CHEO has integrated virtual care delivery through our governance structure, stakeholder engagement including patient, caregivers and health care providers and staff, development, and use of eHealth tools and novel approaches for patient care requiring physical assessment. We conclude with our vision for the future of virtual care, one component of paediatric care delivery in the post-COVID-19 era, which requires a common framework for virtual care evaluation. Importantly, rapid implementation of a primarily virtual care model at CHEO sustained high volume quality paediatric care. We believe many of these programs should and will remain in the post-pandemic era. A comprehensive, unified approach to evaluation is essential to yield meaningful results that inform sustainable care delivery models that integrate virtual care, and ultimately help ensure the best health outcomes for our patients., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Canadian Paediatric Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Aminopenicillins are recommended empiric therapy for community-acquired pneumonia (CAP). The aim of the study was to assess treatment over a 5-year period after CAP guideline publication and introduction of an antimicrobial stewardship program (ASP)., Methods: Using ICD-10 discharge codes for pneumonia, children less than 18 years admitted to the Children's Hospital of Eastern Ontario January 1, 2012 and December 31, 2016 were identified. Children ≥ 2 months with consolidation were included. One day of therapy (DOT) was one or more doses of an antimicrobial given for 1 day., Results: Of 1,707 patients identified, 713 met inclusion criteria. Eighteen (2.5%) had bacteria identified by culture and 79 of 265 (29.8%) had Mycoplasma pneumoniae detected. Mean DOT/1,000 patient days of aminopenicillins/penicillin (AAP) increased by 18.1% per year (95% confidence interval [CI] -0.2, 39.9%) and decreased by 37.6% per year (95% CI -56.1, -11.3%) for second- and third-generation cephalosporins in the post-ASP period. The duration of discharge antimicrobials decreased. Of 74 (10.4%) patients who had pleural fluid drained, 35 (47.3%) received more than 5 days of AAP and ≤ 5 days of second-/third-generation cephalosporins with no difference in median length of stay nor mean duration of antimicrobials., Conclusions: Implementation of CAP management guidelines followed by prospective audit and feedback stewardship was associated with a sustained decrease in the use of broad-spectrum antibiotics in childhood CAP. Use of AAP should also be strongly considered in patients with effusions (even if no pathogen is identified), as clinical outcome appears similar to patients treated with broad-spectrum antimicrobials., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Canadian Paediatric Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration : Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017., Competing Interests: No competing interests were disclosed.

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration : Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017., Competing Interests: No competing interests were disclosed.