Besigye, Fred and Adriko, Moses and Vennervald, Birgitte J and Tukahebwa, Edridah M and Bond, Simon and Wilson, Shona
(2025).
Impact of Increased Praziquantel Frequency on Childhood Fibrosis in Persistent Schistosomiasis Morbidity Hotspots Baseline Parasitology and WASH Infrastructure: 2019 - 2021.
[Data Collection]. Colchester, Essex:
UK Data Service.
10.5255/UKDA-SN-857375
Schistosomiasis remains a major public health problem in many developing countries, Uganda inclusive. It affects the poorest people, living in remote, marginal and rural areas, and causes life-long disability, disfigurement, reduced economic productivity and social stigma. In Hoima District, communities on the shores of Lake Albert retain high infection intensities levels. This is despite concerted efforts to provide annual community wide preventative chemotherapy through mass drug administration (MDA) programmes, with the latest reported coverage rates for districts with Lake Albert shores being above the WHO target of 75% of those eligible for treatment (currently school aged children and adults). Failure to gain control of infection in primary school children can result in the development of persistent morbidity that can be life threatening in adulthood. Without improved intervention we will fail to meet the Sustainable Development Goal 3 aim of promoting well being for all. The data is the baseline parasitology results from a phase IV clinical trial that was at the core of the FibroScHot research programme. The trial aimed to optimise treatment frequency amongst school-aged children living in Lake Albert schistosomiasis transmission hotspots.
Data description (abstract)
Treatment guidelines for schistosomiasis recommend increasing frequency of preventative chemotherapy (PC) administration of praziquantel to twice per annum in persistent hotspots of transmission, in combination with integrated control strategies. FibroScHot was an individual randomised superiority trial designed to examine twice per annum and four times per annum treatment frequency. It was conducted in two primary schools, Buhirigi and Kaiso, in Hoima District Uganda – a designated Schistosoma mansoni high transmission area in which PC is targeted at children and adults. Schistosoma mansoni egg counts were one of the FibroScHot trial outcomes. Outcomes were measured at baseline (2020 and 2021) prior to commencement of scheduled trial treatments with praziquantel and again at the 2-year outcome visit. The data presented here are the demographic data for the trial participants and egg counts based upon one stool collected at baseline. Also provided are the results from a questionnaire on WASH infrastructure in the surrounding communities that was implemented in November 2019.
| Data creators: |
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| Contributors: |
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| Sponsors: |
European and Developing Countries Clinical Trial Partnership 2 Programme
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| Grant reference: |
RIA2017NIM-1842
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| Topic classification: |
Health
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| Keywords: |
UGANDA, SCHOOL-AGE POPULATION, HEALTH, GASTROINTESTINAL DISORDERS, PRIMARY SCHOOLS
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| Project title: |
Impact of increased praziquantel frequency on childhood fibrosis in persistent schistosomiasis morbidity hotspots (FibroScHot) - WP2 Clinical Trial
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| Alternative title: |
FibroScHot
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| Grant holders: |
Dr Shona Wilson, Department of Pathology, University of Cambridge, Dr Edridah Tukahebwa, Vector Control Division, Uganda Ministry of Health, Prof Fred Nuwaha, School of Public Health, Makerere University, Prof Birgitte J Vennervald, University of Copenhagen, Prof Joanne Webster, Royal Veterinary College, Dr Simon Bond, Cambridge University Hospitals NHS Foundation Trust, Dr Stephen Cose, LSHTM
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| Project dates: |
| From | To |
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| 1 August 2018 | 31 August 2024 |
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| Date published: |
15 Nov 2024 17:46
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| Last modified: |
06 Jan 2025 12:17
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| Collection period: |
| Date from: | Date to: |
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| 17 November 2019 | 2 April 2021 |
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| Geographical area: |
Hoima District |
| Country: |
Uganda |
| Data collection method: |
Enrolment into the FibroScHot trial was conducted regardless of Schistosoma mansoni infection status from two schools, Buhirigi and Kaiso in Hoima District, Uganda. Recruitment was initially from the P2 and P3 classes, with later expansion into other classes. Each child was assigned a unique identifier upon enrolment. Age and length of residency in the area were included in the inclusion criteria, along with consent and assent for participation. In total 735 individuals were eligible for inclusion. Biological sex according to the school register was recorded for all participants at enrolment. Due to the COVID-19 pandemic parasitology sampling was split between 2020 and 2021 in Buhirigi Primary. All stool sampling for Kaiso was undertaken in 2021. In total stool samples for Schistosoma mansoni eggs counts were collected from 700 individuals at baseline. Stool samples were processed using the Kato-Katz technique for intestinal schistosome egg counts. When stool sample volume allowed, two slides per stool were prepared. WASH infrastructure availability in the surrounding communities was assessed in November 2019 by implementation of the core questions on household drinking water and sanitation from the 2018 joint monitoring programme (JMP) for water supply and sanitation questionnaire developed by WHO and UNICEF. Prior to implementation the questions were translated into Alur (the main local language). Fifty parents/guardians from Kaiso and 48 parents/guardians from Buhirigi of children attending the P2 class participated. Participants were selected by inviting the parent/guardian of every 4th child on the register. The study code they were provided with was not linked to their child. |
| Observation unit: |
Individual |
| Kind of data: |
Numeric |
| Type of data: |
Cohort and longitudinal studies |
| Resource language: |
English |
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| Data sourcing, processing and preparation: |
All trial data was transferred from source data forms used at point of collection/examination to triplicate paper Case Report Forms (pCRF). Data transfer was checked and signed off by the trial Data Manager and all clinical data entered onto the pCRF assessed for validity by a clinical team member. Data was subsequently transferred to programmed electronic CRF held on MACRO Clinical Trial Software (hosted by Ennov). Eligibility and egg count data from interim data downloads were quality assured by the trial monitor. Quality assurance was completed upon soft lock by the trial statistical team. This open access database was generated from a download of the hard locked database by the Clinical Trials Unit Programmer on 16th September 2024. Further quality assurance checks were run prior to the generation of processed variables for open access. Data generated for this database by processing the hard locked data include the year of school collection and Schistosoma mansoni egg counts per gramme of faeces calculated from the counts from maximum 1 stool, 2 x Kato-Katz slides per stool. The data for six individuals for whom we do not hold consent and/or assent to share their data have been removed from the original data set. The R code for the checks and the data processing conducted on the downloaded hard-locked database are available on the Cambridge Clinical Trials Unit GitHub: https://github.com/cam-ctu/FibroScHot_DataShare/. The WASH questionnaire data was transferred from original paper based data logs to MS Excel by the Database Manager. Data entry against the data logs was quality assured by the primary author of this data collection prior to analysis.
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| Rights owners: |
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| Contact: |
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| Notes on access: |
The UK Data Archive has granted a dissemination embargo. The embargo will end on 21 February 2025 and the data will then be available in accordance with the access level selected.
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| Publisher: |
UK Data Service
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| Last modified: |
06 Jan 2025 12:17
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