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The role of health workers in Kenya’s transition to a net-zero health-care system: a mixed-methods study
Get PDFBackground:
Climate change presents a major challenge to health-care systems, particularly in low-income and middle-income countries such as Kenya. Health workers are key to leading the transition towards a sustainable, climate-resilient health-care system. This mixed-methods study explored the perceptions, knowledge, and roles of Kenyan health workers in mitigation and adaptation in health care.
Methods:
An online questionnaire was used to assess the understanding of health workers regarding the impact of climate change on health, the health-care system’s role in emissions reduction and adaptation, and current practices. A subsequent focus group discussion delved deeper into the identified themes, with a particular focus on educating health workers to support climate action.
Findings:
The questionnaire was completed by 118 health workers. Although the respondents recognised the health risks of climate change, financial constraints and insufficient training were major barriers to implementing sustainable practices. The focus group highlighted the need for practical, context-specific education to equip health workers with actionable knowledge and skills, while also fostering emotional resilience and ethical leadership.
Interpretation:
We recommend co-creating educational programmes with communities and health workers, integrating climate–health modules into curricula, and using innovative approaches such as peer-led workshops and social media campaigns. These insights underscore the transformative potential of education in empowering health workers to lead Kenya’s transition to a sustainable, climate-resilient health-care system
Retinoblastoma with and without Extraocular Tumor Extension: A Global Comparative Study of 3435 Patients.
Get PDFPURPOSE: To study the treatment and outcomes of children with retinoblastoma (RB) with extraocular tumor extension (RB-EOE) and compare them with RB without extraocular tumor extension (RB-w/o-EOE). DESIGN: Multicenter intercontinental collaborative prospective study from 2017 to 2020. RB-EOE cases included those with overt orbital tumor extension in treatment-naive patients. Cases with microscopic orbital extension detected postenucleation were excluded from the study. PARTICIPANTS: A total of 319 children with RB-EOE and 3116 children with RB-w/o-EOE. INTERVENTION: Chemotherapy, enucleation, exenteration, radiotherapy. MAIN OUTCOME MEASURES: Systemic metastasis and death. RESULTS: Of the 3435 RB patients included in this study, 309 (9%) were from low-income countries (LIC), 1448 (42%) from lower-middle income, 1012 (29%) from upper-middle income, and 666 (19%) patients from high-income countries. There was an inverse relationship between the percentage of RB-EOE and national income level, with 96 (31%) patients from LIC, 197 (6%) lower-middle income, 20 (2%) upper-middle income, and 6 (1%) patients from high-income countries (P = 0.0001). The outcomes were statistically significant for RB-EOE compared with RB-w/o-EOE: systemic metastasis (32% vs. 4% respectively; P = 0.0001) and metastasis-related death (63% vs. 6% respectively; P = 0.0001). Multimodal treatment was the most common form of treatment (n = 177; 54%) for RB-EOE, with most cases undergoing a combination of intravenous chemotherapy and enucleation (n = 97; 30%). Adjuvant external beam radiotherapy (EBRT) after surgery (enucleation/orbital exenteration) was given in only 68 (21%) cases. Kaplan-Meier analysis for systemic metastasis and metastasis-related death in RB-EOE was 28% and 57% at 1 year, 29% and 60% at 2 years, and 29% and 61% at 3 years, respectively. Cox regression analysis revealed that the risk of death from RB-EOE was greater in patients aged >4 years than <2 years (hazard ratio, 2.912; P < 0.001) and for unimodal (surgery or intravenous chemotherapy) and bimodal (surgery and intravenous chemotherapy) treatment than trimodal treatment (surgery, intravenous chemotherapy, and EBRT) (hazard ratio, 2.023; P = 0.004 and hazard ratio, 1.819; P = 0.027, respectively). CONCLUSIONS: Retinoblastoma with extraocular tumor extension is associated with a higher risk of metastasis and death. Patients with RB-EOE are likely to benefit from trimodal treatment (intravenous chemotherapy, surgery, and EBRT) rather than treatment protocols excluding EBRT. FINANCIAL DISCLOSURES: The authors have no proprietary or commercial interest in any materials discussed in this article
An innovative Community Mobilisation and Community Incentivisation for child health in rural Pakistan (CoMIC): a cluster-randomised, controlled trial.
Get PDFBACKGROUND: Infectious diseases remain the leading cause of death among children younger than 5 years due to disparities in access and acceptance of essential interventions. The Community Mobilisation and Community Incentivisation (CoMIC) trial was designed to evaluate a customised community mobilisation and incentivisation strategy for improving coverage of evidence-based interventions for child health in Pakistan.
METHODS: CoMIC was a three-arm cluster-randomised, controlled trial in rural areas of Pakistan. Clusters were formed by grouping villages based on geographical proximity, ethnic consistency, and ensuring a population between 1500 to 3000 per cluster. Clusters were randomly assigned (1:1:1) to either community mobilisation, community mobilisation and incentivisation, or the control arm. Community mobilisation included formation of village committees which conducted awareness activities, while clusters in the community mobilisation and incentivisation group were provided with a novel conditional, collective, community-based incentive (C3I) in addition to community mobilisation. C3I was conditioned on serial incremental targets for collective improvement in coverage at cluster level of three key indicators (primary outcomes): proportion of fully immunised children, use of oral rehydration solution, and sanitation index, assessed at 6 months, 15 months, and 24 months, and village committees decided on non-cash incentives for people in the villages. Data were analysed as intention-to-treat by an independent team masked to study groups. The trial is registered at ClinicalTrials.gov, NCT03594279, and is completed.
FINDINGS: Between Oct 1, 2018 and Oct 31, 2020, 21 638 children younger than 5 years from 24 846 households, with a total population of 139 005 in 48 clusters, were included in the study. 16 clusters comprising of 152 villages and 7361 children younger than 5 years were randomly assigned to the community mobilisation and incentivisation group; 16 clusters comprising of 166 villages and 7546 children younger than 5 years were randomly assigned to the community mobilisation group; and 16 clusters comprising of 139 villages and 6731 children younger than 5 years were randomly assigned to the control group. Endline analyses were conducted on 3812 children (1284 in the community mobilisation and incentivisation group, 1276 in the community mobilisation group, and 1252 in the control group). Multivariable analysis indicates improvements in all primary outcomes including a higher proportion of fully immunised children (risk ratio [RR] 1·3 [95% CI 1·0-1·5]), higher total sanitation index (mean difference 1·3 [95% CI 0·6-1·9]), and increased oral rehydration solution use (RR 1·5 [1·0-2·2]) in the community mobilisation and incentivisation group compared with the control group at 24 months. There was no evidence of difference between community mobilisation and control for any of the primary outcomes.
INTERPRETATION: Community mobilisation and incentivisation led to enhanced acceptance evidenced by improved community behaviours and increased coverage of essential interventions for child health. These findings have the potential to inform policy and future implementation of programmes targeting behaviour change but would need evaluation for varying outcomes and different contexts.
FUNDING: Bill & Melinda Gates Foundation.
TRANSLATIONS: For the Sindhi and Urdu translations of the abstract see Supplementary Materials section
Methodological expectations for demonstration of health product effectiveness by observational studies.
Get PDFThe issue of assessing the effectiveness of health technologies (drugs, devices, etc.) through observational studies is becoming increasingly important as registration and market access agencies consider them in their evaluation process. In this context, observational studies must be able to provide real demonstrations of a level of reliability comparable to those produced by the conventional randomized controlled trial (RCT) approach. The objective of the roundtable was to establish the acceptability criteria for an observational study (non-randomized, non-interventional study) to be able to provide these demonstrations, and possibly serve as a confirmatory study for registration and market access authorities, the construction of therapeutic strategies or the development of recommendations. In order to do this, the study must be a real confirmatory study respecting the hypothetical-deductive approach and guaranteeing the absence of HARKing and p-hacking by attesting to the establishment of a protocol and a statistical analysis plan, recorded before any inferential analysis. It must also be part of a formalized approach to causal inference and demonstrate that it correctly identifies the causal estimand sought. The study should ensure that there is no residual confusion bias by taking into account all confounding factors affecting the comparison, which should be determined by a formal approach (such as a graphical causality approach, DAGs). Residual confusion bias diagnoses by forgery and nullification analysis should be non-existent. The study shall be at low risk of bias, in particular selection bias, among others by using a target test emulation design. Overall type I error risk should be strictly controlled. The absence of selective publication of results and selection bias should be ensured
School-based group interpersonal therapy for adolescents with depression in nepal: protocol for a phase III realist cluster-randomised controlled trial.
Get PDFBACKGROUND: Depression is a leading cause of disability among adolescents, with the burden disproportionately affecting low- and middle-income countries (LMICs) where access to mental health care is limited. Interpersonal therapy (IPT), a structured psychological intervention, has shown promise in treating adolescent depression but there is limited evidence from LMICs and research on how it works and in which contexts it works best. This protocol describes a realist cluster-randomised controlled trial (cRCT) assessing the effectiveness, cost-utility and mechanisms of school-based group IPT for adolescents with depression in Nepal.
METHODS: This superiority phase III cRCT will be conducted in 48 public secondary schools across Chitwan and Nawalpur districts, with schools randomised 1:1 to intervention or enhanced usual care. Adolescents aged 13–19 with depression (Patient Health Questionnaire modified for adolescents, PHQ-A score ≥11) will be recruited from grades 7–9. The intervention comprises two individual and ten weekly group IPT sessions delivered by trained lay facilitators. Adolescents will be surveyed pre-randomisation (baseline) and five (midline), 17 (endline) and 32 weeks (follow-up) post randomisation. The primary outcome is depression severity at 17 weeks post-randomisation assessed using the PHQ-A. Secondary outcomes include anxiety, post-traumatic stress disorder, functional impairment, school attendance and quality of life. Intermediate outcomes including hope, emotion regulation, and social support will be assessed to examine mechanisms of change. A priori hypotheses concerning IPT’s mechanisms and contextual factors influencing these (context-mechanism-outcome configurations) will be refined through analysis of qualitative process data and tested in mediation, moderation and moderated mediation analyses of trial data. Economic evaluation will estimate cost-utility and benefit-cost ratios from both provider and modified societal perspectives. The process evaluation will assess fidelity, reach, and acceptability in various school settings.
DISCUSSION: This trial is the first to integrate realist evaluation into a cRCT of a psychological intervention for adolescents in a LMIC and has potential to advance research and practice by elucidating how IPT works in a real-world context. If IPT is effective in Nepal, it could be scaled up through the education system as a part of a comprehensive school mental health care package.
TRIAL REGISTRATION: ISRCTN52852397 (registered 21/03/2025)
Piloting the Schistosomiasis Practical and Precision Assessment approach in five health districts of the N'zérékoré region, Republic of Guinea.
Get PDFBACKGROUND: In Guinea, N'Zérékoré region has historically been endemic for both Schistosoma mansoni and S. haematobium. Following eight years of mass treatment with praziquantel to treat schistosomiasis, as part of a multi-country project, the country was selected to pilot the Schistosomiasis Practical and Precision Assessment (SPPA) approach. The SPPA pilot was conducted in five health districts in the forest region. The main objectives were to determine the current infection status and treatment strategy for each health sub-district and to evaluate the feasibility of the SPPA approach.
METHODOLOGY/PRINCIPAL FINDINGS: A cross-sectional study among children aged 10-14 years of age was conducted. In each health district, a systematic sample of 15 schools were selected with 32 school children selected randomly from each. Stool and urine samples were collected from each child. Two Kato-Katz slides were examined for S. mansoni and soil transmitted helminthiasis (STH) and one urine filtration slide and one hemastix for S. haematobium infections and microhaematuria, respectively. Of the 2400 children targeted for inclusion, 2325 provided samples (96.9%). The combined prevalence of Schistosoma species across the five health districts was 66.4%. S. mansoni had a high prevalence of 66.1% with four health districts above 50%. S. haematobium had a low prevalence of 4.3%. The overall prevalence of any combined STH (Ascaris lumbricoides, Trichuris trichiura or hookworm) was 11.7%. Sex, age and contact with a freshwater body during the last week before the survey, were not statistically significant in their association with schistosomiasis.
CONCLUSION: The results of the SPPA indicate that schistosomiasis remains homogeneously high across all five health districts. Consequently, it is recommended to maintain annual treatment in each sub-health district, and to extend treatment to whole communities aged two years of age and over, while strengthening critical cross-sectoral interventions such as behaviour change and environmental management
Financial incentives to improve uptake of partner treatment for sexually transmitted infections in antenatal care: a cluster randomised trial in Zimbabwe.
Get PDFBACKGROUND: Partner treatment is an essential component of sexually transmitted infection (STI) case management. We aimed to compare the uptake of partner treatment for STIs within antenatal care in Zimbabwe, with and without the provision of a financial incentive. METHODS: The present cluster randomised trial was embedded within a prospective study (IPSAZ) evaluating point-of-care STI screening among pregnant women in Harare, Zimbabwe. Any pregnant woman attending one of two study clinics for antenatal care was eligible for participation in the IPSAZ study. For the current embedded trial, the study population was those women enrolled and screened in the IPSAZ study who were diagnosed with a curable STI or treated for an STI syndrome (index participants), between Jan 23 and Oct 23, 2023. Clinic days were randomised (1:1) by computer-based randomisation to be an intervention (incentive) day or non-intervention (standard-of-care control) day. On intervention days, index participants were offered partner slips that entitled their partners to US$3 in compensation if they attended the same clinic for treatment. On control days, non-incentivised partner slips were offered. Participants were masked to the intervention before receipt of partner slips, while researchers including outcome assessors were unmasked. The primary outcome was the proportion of index participants, among those who took at least one partner slip, who had at least one partner attend the study clinic for treatment within 28 days of index diagnosis. This outcome was compared across the intervention and control groups by individual-level logistic regression, with robust standard errors to account for clustering, and analysed by intention to treat. Thematic analysis of two focus group discussions with pregnant women and 57 semi-structured interviews with pregnant women, partners, health-care staff, and intervention team members was also conducted. The parent IPSAZ study was registered on ClinicalTrials.gov (NCT05541081), and the current embedded trial was registered on the Pan African Clinical Trials Registry (PACTR202302702036850), both of which have been completed. FINDINGS: Between Jan 23 and Oct 23, 2023, 323 participants were diagnosed with a curable STI or treated for an STI syndrome. 156 (48%) of these index participants were randomly assigned to receive incentivised partner slips and 167 (52%) to receive standard-of-care control partner slips across 171 clusters (85 intervention clusters and 86 control clusters). Overall uptake of one or more partner slips by index participants was 91% (294 of 323 participants), with 87% uptake (136 of 156) in the intervention group and 95% uptake (158 of 167) in the control group. The median age of the 294 index participants who took partner slips was 24 years (IQR 21-29). No notable imbalances were observed in participant characteristics between the trial groups. Partners attended the clinic for treatment within 28 days of index diagnosis for 39 (29%) of 136 index participants who took at least one partner slip in the intervention group, and for 42 (27%) of 158 in the control group (odds ratio 1·11 [95% CI 0·66-1·86]; p=0·69). We identified potential barriers across the pathway from index diagnosis to partner treatment. Barriers to pregnant women informing partners included perceived risks of informing partners and complex relationship structures. Barriers to partner attendance were both structural, including time and costs, and cultural, including how men perceived clinics and their engagement with health care. Crucially, partners were not always aware of the availability of incentives. INTERPRETATION: Financial incentives did not address barriers to index participants informing partners, and ultimately did not improve partner attendance for STI treatment. Multifaceted packages addressing barriers for both the index individual and partner, and influencing multiple points in the partner notification and treatment pathway, are likely required to facilitate partner treatment. FUNDING: Wellcome Trust
Recombinant production platform for Group A Streptococcus glycoconjugate vaccines.
Get PDFGroup A Streptococcus (Strep A) is a human-exclusive bacterial pathogen killing annually more than 500,000 patients, and no current licensed vaccine exists. Strep A bacteria are highly diverse, but all produce an essential, abundant, and conserved surface carbohydrate, the Group A Carbohydrate, which contains a rhamnose polysaccharide (RhaPS) backbone. RhaPS is a validated universal vaccine candidate in a glycoconjugate prepared by chemical conjugation of the native carbohydrate to a carrier protein. We engineered the Group A Carbohydrate biosynthesis pathway to enable recombinant production using the industry standard route to couple RhaPS to selected carrier proteins within Escherichia coli cells. The structural integrity of the produced recombinant glycoconjugate vaccines was confirmed by Nuclear Magnetic Resonance (NMR) spectroscopy and mass spectrometry. Purified RhaPS glycoconjugates elicited carbohydrate-specific antibodies in mice and rabbits and bound to the surface of multiple Strep A strains of diverse M-types, confirming the recombinantly produced RhaPS glycoconjugates as valuable vaccine candidates
Estimating the need for diabetic retinopathy services in north India: evidence from a population-based survey in the catchment population of an eye care provider in central Uttar Pradesh.
Get PDFOBJECTIVE: The aim of this study was to assess the prevalence of diabetic retinopathy (DR) and retina screening coverage among people with diabetes in the catchment area of a high-volume eye care organisation in north India. DESIGN: A population-based cross-sectional study using Rapid Assessment of Avoidable Blindness survey, including the DR module. SETTING: A customised rural district in the catchment of Dr Shroff's Charity Eye Hospital in Uttar Pradesh in north India. PARTICIPANTS: 4095 people of age 50 years and above were enrolled using a two-staged cluster sampling, 3867 (94.4%) participated; 2167 (52.9%) were women. 3803 of 4095 (92.9%) participants were assessed for diabetes. People with already diagnosed diabetes and anyone with a random blood glucose ≥200 mg/dL were offered dilated fundus examination. PRIMARY AND SECONDARY OUTCOMES: Primary and secondary outcomes were the prevalence of DR and screening coverage for DR, respectively. RESULTS: The prevalence of diabetes was 7.0% (95% CI 5.9% to 8.0%). 50.2% of all people with diabetes were newly detected. The prevalence of any DR among people with diabetes who consented to dilated pupillary examination was 22.8% (51 of 224), (95% CI 18.2% to 27.3%). 5.8% (13/224) of people with diabetes were found to have sight-threatening DR and only 15.4% (2/13) had received treatment. 84.8% of people with previously diagnosed diabetes had never had their eyes tested for DR; this was significantly higher in women (90.2% vs 76.0%, respectively, p10 years and poor glycaemic control (OR of 1.8 and 1.6, respectively), but this was not found to be statistically significant. CONCLUSION: The prevalence of DR in this predominantly rural setting was found to be higher than the national average. Coverage of retinal screening and treatment was found to be very low. Working with general health providers to increase detection of people with diabetes and leveraging vision centres to improve DR screening coverage is needed in this region
Effects and costs of a multi-component menstrual health intervention (MENISCUS) on mental health problems, educational performance, and menstrual health in Ugandan secondary schools: an open-label, school-based, cluster-randomised controlled trial.
Get PDFBACKGROUND: Menstrual health is a human rights issue, affecting many aspects of life including mental health, wellbeing, and education. We assessed the effectiveness and costs of a school-based, multi-component menstrual health intervention (MENISCUS) to improve mental health problems and educational performance among in-school adolescents. METHODS: We conducted a parallel-arm, cluster-randomised trial in secondary schools in Wakiso and Kalungu districts in Uganda. Schools were eligible for inclusion if they had both male and female students; senior 1-4 classes; day or mixed day and boarding students; at least minimal water, sanitation, and hygiene (WASH) facilities; and enrolments of 50-125 female Senior 1 students in Wakiso district and 40-125 female Senior 1 students in Kalungu district. Schools were randomised (1:1) to the intervention or control condition, stratified by district and baseline mean school examination score. The intervention included creating action groups, strengthening teacher-delivered puberty education, distributing menstrual kits, supporting student-led drama skits, providing pain-management strategies, and improving school water and sanitation facilities. The control condition was provision of printed government menstrual health materials. Schools, participants, and implementors, including the study clinician who monitored adverse events, could not be masked to allocation status. Primary outcomes were mental health problems using the Strength and Difficulties Questionnaire (SDQ) Total Difficulties Score and independently assessed educational performance at individual level, assessed in all female participants at endline. We estimated cluster-intention-to-treat intervention effects using mixed-effects models accounting for school clustering and adjusted for randomisation strata and baseline school-level means of outcomes. The study was registered at the ISRCTN registry, ISRCTN45461276 and is completed. FINDINGS: 60 randomly selected schools (44 from Wakiso and 16 from Kalungu) were randomly assigned (30 per group) to the intervention or the control group, and none withdrew. Between March 21 and July 5, 2022, 3841 female students participated in baseline assessments (89·7% of those eligible) and between June 5 and Aug 22, 2023, 3356 participated in endline assessments (1666 in the control group and 1690 in the intervention group). Female participants had a median age of 16 years (IQR 15-16). At endline, there was no evidence of a difference in mental health problems (mean SDQ score, 10·8 in the intervention group vs 10·7 in the control group; adjusted mean difference [aMD] 0·05 [95% CI -0·40 to 0·50]) nor educational performance (mean z score, 0·20 in the intervention group vs 0·12 in the control group; aMD 0·05 [95% CI -0·10 to 0·19]), despite improvements to menstrual health. The annual implementation cost was US$85 per Senior 2 female student. One participant had a serious adverse event (severe anaemia secondary to excess vaginal bleeding), which was deemed to be possibly related to the intervention. INTERPRETATION: Improving multiple dimensions of menstrual health in secondary schools in Uganda is important for health and human rights but is not sufficient to improve mental health or educational performance over 1 year. FUNDING: UK Foreign, Commonwealth and Development Office; Medical Research Council; Department of Health and Social Care; and Wellcome