scholarly journals Village-Integrated Eye Worker trial (VIEW): rationale and design of a cluster-randomised trial to prevent corneal ulcers in resource-limited settings

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021556 ◽  
Author(s):  
Kieran S O’Brien ◽  
Raghunandan Byanju ◽  
Ram Prasad Kandel ◽  
Bimal Poudyal ◽  
Mariya Gautam ◽  
...  
Keyword(s):  
Community Health ◽  
San Francisco ◽  
Negative Binomial ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Corneal Ulceration ◽  
Resource Limited Settings ◽  
Corneal Ulcers ◽  
Cluster Randomised ◽  
Resource Limited

IntroductionCorneal opacity is a leading cause of blindness worldwide. In resource-limited settings, untreated traumatic corneal abrasions may result in infection and ultimately, opacity. Although antimicrobial treatment of corneal ulcers may successfully cure infections, the scarring that accompanies the resolution of infection can still result in visual impairment. Prevention may be the optimal approach for reducing corneal blindness. Studies have employed community health workers to provide prompt administration of antimicrobials after corneal abrasions to prevent infections, but these studies were not designed to determine the effectiveness of such a programme.Methods and analysisThe Village-Integrated Eye Worker trial (VIEW) is a cluster-randomised trial designed to assess the effectiveness of a community health worker intervention to prevent corneal ulcers. Twenty-four Village Development Committees (VDCs) in Nepal were randomised to receive a corneal ulcer prevention programme or to no intervention. Female Community Health Volunteers (FCHVs) in intervention VDCs are trained to diagnose corneal abrasions, provide antimicrobials and to refer participants when needed. An annual census is conducted over 3 years in all study VDCs to assess the incidence of corneal ulceration via corneal photography (primary outcome). Masked outcome assessors grade corneal photographs to determine the presence or absence of incident corneal opacities. The primary analysis is negative binomial regression to compare the incidence of corneal ulceration by study arm.Ethics and disseminationThe University of California San Francisco Committee on Human Research, Nepal Netra Jyoti Sangh and the Nepal Health Research Council have given ethical approval for the trial. The results of this trial will be presented at local and international meetings and submitted to peer-reviewed journals for publication.Trial registration numberNCT01969786; Pre-results.

scholarly journals Protocol for a cluster randomised trial in Madhya Pradesh, India: Community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2)

2020 ◽  
Author(s):  
Arjun Agarwal ◽  
Rukmini Banerji ◽  
Peter Boone ◽  
Diana Elbourne ◽  
Ila Fazzio ◽  
...  
Keyword(s):  
Community Health ◽  
Rural Areas ◽  
Controlled Trial ◽  
Health Centre ◽  
Randomised Trial ◽  
First Grade ◽  
Madhya Pradesh ◽  
Cluster Randomised Trial ◽  
Education Intervention ◽  
Cluster Randomised

Abstract Background Rural areas of India exhibit high neonatal mortality, and low literacy and numeracy. We assess the effect of a complex package of health interventions on neonatal survival, and the effect of out-of-school-hours teaching on children’s literacy and numeracy, in rural Madhya Pradesh. Methods/Design This is a cluster-randomised controlled trial with villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial villages receiving the health intervention are controls for the education intervention, and vice versa. Clusters 196 villages in Satna district, Madhya Pradesh, India: each at least five kilometres from a Community Health Centre, a population below 2,500, and at least 15 children eligible for the education intervention. Participants CHAMPION2 - resident married women under 50 without a family planning operation, provided they are enumerated pre-randomisation, or marry a man enumerated pre-randomisation. STRIPES2 - resident children born 16June 2010-15June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020.

scholarly journals Protocol for a cluster randomised trial in Madhya Pradesh, India: Community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2)

2020 ◽  
Author(s):  
Arjun Agarwal ◽  
Rukmini Banerji ◽  
Peter Boone ◽  
Diana Elbourne ◽  
Ila Fazzio ◽  
...  
Keyword(s):  
Community Health ◽  
Rural Areas ◽  
Controlled Trial ◽  
Health Centre ◽  
Randomised Trial ◽  
First Grade ◽  
Madhya Pradesh ◽  
Cluster Randomised Trial ◽  
Education Intervention ◽  
Cluster Randomised

Abstract Background Rural areas of India exhibit high neonatal mortality, and low literacy and numeracy. We assess the effect of a complex package of health interventions on neonatal survival, and the effect of out-of-school-hours teaching on children’s literacy and numeracy, in rural Madhya Pradesh.Methods/Design This is a cluster-randomised controlled trial with villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial villages receiving the health intervention are controls for the education intervention, and vice versa.Clusters 196 villages in Satna district, Madhya Pradesh, India: each at least five kilometres from a Community Health Centre, a population below 2,500, and at least 15 children eligible for the education intervention. Participants CHAMPION2 - resident married women under 50 without a family planning operation, provided they are enumerated pre-randomisation, or marry a man enumerated pre-randomisation. STRIPES2 - resident children born 16June 2010-15June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020.

scholarly journals Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e039895
Author(s):  
Rebecca Crowder ◽  
Alex Kityamuwesi ◽  
Noah Kiwanuka ◽  
Maureen Lamunu ◽  
Catherine Namale ◽  
...  
Keyword(s):  
San Francisco ◽  
Randomised Trial ◽  
Scale Up ◽  
Treatment Completion ◽  
Routine Care ◽  
Cluster Randomised Trial ◽  
Institutional Review Boards ◽  
Stepped Wedge ◽  
Tb Treatment ◽  
Cluster Randomised

IntroductionLow-cost digital adherence technologies (DATs) such as 99DOTS have emerged as an alternative to directly observed therapy (DOT), the current standard for tuberculosis (TB) treatment supervision. However, there are limited data to support DAT scale-up. The ‘DOT to DAT’ trial aims to evaluate the effectiveness and implementation of a 99DOTS-based TB treatment supervision strategy.Methods and analysisThis is a pragmatic, stepped-wedge cluster randomised trial, with hybrid type 2 effectiveness-implementation design. The trial will include all adults (estimated N=1890) treated for drug-susceptible pulmonary TB over an 8-month period at 18 TB treatment units in Uganda. Three sites per month will switch from routine care (DOT) to the intervention (99DOTS-based treatment supervision) beginning in month 2, with the order determined randomly. 99DOTS enables patients to be monitored while self-administering TB medicines. Patients receive daily automated short message service (SMS) dosing reminders and confirm dosing by calling toll-free numbers. The primary effectiveness outcome is the proportion of patients completing TB treatment. With 18 clusters randomised into six steps and an average cluster size of 15 patients per month, the study will have 89% power to detect a 10% or greater increase in treatment completion between the routine care and intervention periods. Secondary outcomes include more proximal effectiveness measures as well as quantitative and qualitative assessments of the reach, adoption and implementation of the intervention.Ethics and disseminationEthics approval was granted by institutional review boards at Makerere University School of Public Health and the University of California San Francisco. Findings will be disseminated through peer-reviewed publications, presentations at scientific conferences and presentations to key stakeholders.Trial registration numberPACTR201808609844917.

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