scholarly journals Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls: study protocol of a cluster-randomised controlled trial in western Kenya

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Garazi Zulaika ◽  
Daniel Kwaro ◽  
Elizabeth Nyothach ◽  
Duolao Wang ◽  
Emily Zielinski-Gutierrez ◽  
...  
Keyword(s):  
School Dropout ◽  
Cash Transfer ◽  
Sub Saharan Africa ◽  
School Level ◽  
Early Marriage ◽  
Western Kenya ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Adolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection. This study evaluates the impact of menstrual cups and cash transfer interventions on a composite of deleterious outcomes (HIV, HSV-2, and school dropout) when given to secondary schoolgirls in western Kenya, with the aim to inform evidence-based policy to improve girls’ health, school equity, and life-chances. Methods Single site, 4-arm, cluster randomised controlled superiority trial. Secondary schools are the unit of randomisation, with schoolgirls as the unit of measurement. Schools will be randomised into one of four intervention arms using a 1:1:1:1 ratio and block randomisation: (1) menstrual cup arm; (2) cash transfer arm, (3) cups and cash combined intervention arm, or (4) control arm. National and county agreement, and school level consent will be obtained prior to recruitment of schools, with parent consent and girls’ assent obtained for participant enrolment. Participants will be trained on safe use of interventions, with all arms receiving puberty and hygiene education. Annually, the state of latrines, water availability, water treatment, handwashing units and soap in schools will be measured. The primary endpoint is a composite of incident HIV, HSV-2, and all-cause school dropout, after 3 years follow-up. School dropout will be monitored each term via school registers and confirmed through home visits. HIV and HSV-2 incident infections and risk factors will be measured at baseline, mid-line and end-line. Intention to treat analysis will be conducted among all enrolled participants. Focus group discussions will provide contextual information on uptake of interventions. Monitoring for safety will occur throughout. Discussion If proved safe and effective, the interventions offer a potential contribution toward girls’ schooling, health, and equity in low- and middle-income countries. Trial registration ClinicalTrials.gov NCT03051789, 15th February 2017.

scholarly journals Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036096 ◽  
Author(s):  
Christine Adrion ◽  
Bjoern Weiss ◽  
Nicolas Paul ◽  
Elke Berger ◽  
Reinhard Busse ◽  
...  
Keyword(s):  
Critical Care ◽  
Intensive Care ◽  
Critical Illness ◽  
Stepped Wedge ◽  
Link Type ◽  
Cluster Randomised ◽  
Icu Discharge ◽  
Randomised Controlled ◽  
The Impact

IntroductionSurvival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium-term or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognised as post-intensive care syndrome (PICS). There are evidence-based and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients’ long-term outcomes if adhered to.Methods and analysisThe protocol of a multicentre, pragmatic, stepped wedge cluster randomised controlled, quality improvement trial is presented. During 3 predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a one-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient’s ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.Ethics and disseminationThis protocol was approved by the ethics committee of the Charité—Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed scientific journal and presented at international conferences. Study findings will also be disseminated via the website (www.eric-projekt.net).Trial registration numberClinicalTrials.gov Registry (NCT03671447).

scholarly journals B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage ofNeisseria meningitidisin adolescents

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e020988 ◽  
Author(s):  
Helen S Marshall ◽  
Mark McMillan ◽  
Ann Koehler ◽  
Andrew Lawrence ◽  
Jenny M MacLennan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
School Level ◽  
School Students ◽  
Notification Rate ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Impact ◽  
Carriage Prevalence

IntroductionSouth Australia (SA) has the highest notification rate of invasive meningococcal disease in Australia with the majority of cases due to serogroup B.Neisseria meningitidisis carried in the pharynx, with adolescents having the highest rates of carriage. A vaccine designed to offer protection against serogroup B (4CMenB) is licensed in Australia. The SA MenB vaccine carriage study aims to assess the impact of 4CMenB on carriage ofN. meningitidisin adolescents.Methods and analysisThis is a parallel cluster randomised controlled trial enrolling year 10, 11 and 12 school students (approximately 16–18 years of age) throughout SA, in metropolitan and rural/remote areas. Schools are randomised to intervention (4CMenB vaccination at baseline) or control (4CMenB vaccination at study completion) with randomisation stratified by school size and socioeconomic status, as measured by the Index of Community Socio-Educational Advantage (Australian Curriculum). Oropharyngeal swabs will be taken from all students at visit 1, and 12 months later from year 11 and 12 students. Students unvaccinated in 2017 will receive vaccine at the 12-month follow-up. Carriage prevalence ofN. meningitidiswill be determined by PCR at baseline and 12 months following 4CMenB vaccination and compared with carriage prevalence at 12 months in unvaccinated students. A questionnaire will be completed at baseline and 12 months to assess risk factors associated with carriage. The primary outcome of carriage prevalence of disease causingN. meningitidisat 12 months will be compared between groups using logistic regression, with generalised estimating equations used to account for clustering at the school level. The difference in carriage prevalence between groups will be expressed as an OR with 95% CI.Ethics and disseminationThe study was approved by the Women’s and Children’s Health Network Human Research Ethics Committee (WCHN HREC). The protocol, informed consent forms, recruitment materials, social media and all participant materials have been reviewed and approved by the WCHN HREC and updated on ClinicalTrials.gov. Results will be published in international peer-reviewed journals and presented at national and international conferences. The study findings will be provided in public forums and to study participants and participating schools.Trial registration numberACTRN12617000079347.NCT03089086; Pre-results.

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

scholarly journals Shonjibon cash and counselling: a community-based cluster randomised controlled trial to measure the effectiveness of unconditional cash transfers and mobile behaviour change communications to reduce child undernutrition in rural Bangladesh

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Tanvir M. Huda ◽  
Ashraful Alam ◽  
Tazeen Tahsina ◽  
Mohammad Mehedi Hasan ◽  
Afrin Iqbal ◽  
...  
Keyword(s):  
Mobile Phone ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cash Transfers ◽  
Cash Transfer ◽  
Child Undernutrition ◽  
Change Communication ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
Unconditional Cash Transfers

Abstract Background Undernutrition is strongly associated with poverty - levels of undernutrition are higher in poor countries than in better-off countries. Social protection especially cash transfer is increasingly recognized as an important strategy to accelerate progress in improving maternal and child nutrition. A critical method to improve nutrition knowledge and influence feeding practices is through behaviour change communication intervention. The Shonjibon Cash and Counselling study aims to assess the effectiveness of unconditional cash transfers combined with a mobile application on nutrition counselling and direct counselling through mobile phone in reducing the prevalence of stunting in children at 18 months. Method The study is a longitudinal cluster randomised controlled trial, with two parallel groups, and cluster assignment by groups of villages. The cohort of mother-child dyads will be followed-up over the intervention period of approximately 24 months, starting from recruitment to 18 months of the child’s age. The study will take place in north-central Bangladesh. The primary trial outcome will be the percentage of stunted children at 18 m as measured in follow up assessments starting from birth. The secondary trial outcomes will include differences between treatment arms in (1) Mean birthweight, percentage with low birthweight and small for gestational age (2) Mean child length-for age, weight for age and weight-for-length Z scores (3) Prevalence of child wasting (4) Percentage of women exclusively breastfeeding and mean duration of exclusive breastfeeding (5) Percentage of children consuming > 4 food groups (6) Mean child intake of energy, protein, carbohydrate, fat and micronutrients (7) Percentage of women at risk of inadequate nutrient intakes in all three trimesters (8) Maternal weight gain (9) Household food security (10) Number of events for child suffering from diarrhoea, acute respiratory illness and fever (11) Average costs of mobile phone BCC and cash transfer, and benefit-cost ratio for primary and secondary outcomes. Discussion The proposed trial will provide high-level evidence of the efficacy and cost-effectiveness of mobile phone nutrition behavior change communication, combined with unconditional cash transfers in reducing child undernutrition in rural Bangladesh. Trial registration The study has been registered in the Australian New Zealand Clinical Trials Registry (ACTRN12618001975280).

scholarly journals Cash Transfers and Child Nutrition: Evidence from sub-Saharan Africa

2021 ◽  
Vol 5 (3) ◽  
Author(s):  
Oladayo Nathaniel Awojobi
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Child Nutrition ◽  
Cash Transfers ◽  
Cash Transfer ◽  
Sub Saharan Africa ◽  
Controlled Trials ◽  
Sub Saharan ◽  
Randomised Controlled ◽  
Nutritional Outcomes

This paper summarises the arguments and counterarguments within the scientific discussion on cash transfers and child nutrition. The main purpose of the research is to assess the effectiveness of cash transfers in improving nutritional outcomes in vulnerable children in sub-Saharan Africa. Systematisation of the literary sources indicates that studies have justified cash transfer as social-income support that addresses a vital social determinant of health (income) for children in low-and-middle-income countries. The methodological basis of this study is a systematic review that searched a wide range of academic and grey literature databases, including PubMed, Cochrane Library and Google Scholar. This study included cluster-randomised controlled trials (R.C.T.s), randomised controlled trials, quasi-experimental studies, mixed-methods studies, and non-randomised cluster trials. Studies included in this systematic review were screened for their eligibility. The systematic review uses the Cochrane data collection form to extract data from the included studies. It was not feasible to statistically combine the results of the studies due to the heterogeneity of most of the studies. Preferably, the review employs a narrative synthesis to present the estimated effects of cash transfers on children’s nutritional outcomes. The systematic review presents the results of data synthesis, of which eleven studies met the inclusion criteria. Overall, the evidence from the systematic review indicates that cash transfer programmes targeted at children effectively improve anthropometric and nutritional outcomes. Further research is needed to spell out the multiple pathways to how cash transfers improve children’s nutritional outcomes. Moreover, this systematic review shows the importance of cash transfers in improving child nutrition. Policymakers should continue to employ institutional mechanisms to strengthen the nutritional status of children, especially the vulnerable ones since cash transfer intervention is a temporary measure.

scholarly journals mHealth tool to improve community health agent performance for child development: study protocol for a cluster-randomised controlled trial in Peru

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e028361 ◽  
Author(s):  
Christopher Michael Westgard ◽  
Natalia Rivadeneyra ◽  
Patricia Mechael
Keyword(s):  
Child Development ◽  
Child Health ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Child Rearing ◽  
Development Indicators ◽  
Cluster Randomised ◽  
Health And Development ◽  
Randomised Controlled ◽  
The Impact

IntroductionCultivating child health and development creates long-term impact on the well-being of the individual and society. The Amazon of Peru has high levels of many risk factors that are associated with poor child development. The use of ‘community health agents’ (CHAs) has been shown to be a potential solution to improve child development outcomes. Additionally, mobile information and communication technology (ICT) can potentially increase the performance and impact of CHAs. However, there is a knowledge gap in how mobile ICT can be deployed to improve child development in low resource settings.Methods and analysisThe current study will evaluate the implementation and impact of a tablet-based application that intends to improve the performance of CHAs, thus improving the child-rearing practices of caregivers and ultimately child health and development indicators. The CHAs will use the app during their home visits to record child health indicators and present information, images and videos to teach key health messages. The impact will be evaluated through an experimental cluster randomised controlled trial. The clusters will be assigned to the intervention or control group based on a covariate-constrained randomisation method. The impact on child development scores, anaemia and chronic malnutrition will be assessed with an analysis of covariance. The secondary outcomes include knowledge of healthy child-rearing practices by caregivers, performance of CHAs and use of health services. The process evaluation will report on implementation outcomes. The study will be implemented in the Amazon region of Peru with children under 4. The results of the study will provide evidence on the potential of a mHealth tool to improve child health and development indicators in the region.Ethics and disseminationThe study received approval from National Hospital ‘San Bartolome’ Institutional Ethics Committee on 8 November 2018 (IRB Approval #15463–18) and will be disseminated via peer-reviewed publications.Trial registration numberISRCTN43591826.

scholarly journals Social capital is associated with lower mosquito vector indices: secondary analysis from a cluster randomised controlled trial of community mobilisation for dengue prevention in Mexico

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Víctor Alvarado-Castro ◽  
Sergio Paredes-Solís ◽  
Elizabeth Nava-Aguilera ◽  
Arcadio Morales-Pérez ◽  
Miguel Flores-Moreno ◽  
...  
Keyword(s):  
Social Capital ◽  
Multivariate Analysis ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Cluster Randomised Controlled Trial ◽  
Community Mobilisation ◽  
Cluster Randomised ◽  
Camino Verde ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Control of the Aedes aegypti mosquito is central to reducing the risk of dengue, zika, chikungunya, and yellow fever. Randomised controlled trials, including the Camino Verde trial in Mexico and Nicaragua, demonstrate the convincing impact of community mobilisation interventions on vector indices. These interventions might work through building social capital but little is known about the relationship between social capital and vector indices. Methods A secondary analysis used data collected from 45 intervention clusters and 45 control clusters in the impact survey of the Mexican arm of the Camino Verde cluster randomised controlled trial. Factor analysis combined responses to questions about aspects of social capital to create a social capital index with four constructs, their weighted averages then combined into a single scale. We categorised households as having high or low social capital based on their score on this scale. We examined associations between social capital and larval and pupal vector indices, taking account of the effects of other variables in a multivariate analysis. We report associations as odds ratios and 95% confidence intervals. Results The four social capital constructs were involvement, participation, investment, and communication. Among the 10,112 households, those in rural communities were much more likely to have a high social capital score (OR 4.51, 95% CIca 3.26–6.26). Households in intervention sites had higher social capital, although the association was not significant at the 5% level. Households with high social capital were more likely to be negative for larvae or pupae (OR 1.38, 95% CIca 1.12–1.69) and for pupae specifically (OR 1.37, 95% CIca 1.08–1.74). There was interaction between intervention status and social capital; in multivariate analysis, a combined variable of intervention/high social capital remained associated with larvae or pupae (ORa l.56, 95% CIca 1.19–2.04) and with pupae specifically (ORa 1.65, 95% CIca 1.20–2.28). Conclusion This is the first report of an association of high social capital with low vector indices. Our findings support the idea that the Camino Verde community mobilisation intervention worked partly through an interaction with social capital. Understanding such interactions may help to maximise the impact of future community mobilisation interventions.

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