Browse the DeWorm3 protocols, standard operating procedures, training aids and case report forms.
Disclaimer: Content provided on this site contains the most recent version of the file at the time of Intervention Phase completion.
TRIAL PROTOCOLS
DeWorm3 trial protocol
PLoS Neglected Tropical Diseases 12(1), 2018
DeWorm3 implementation science protocol
PLoS Neglected Tropical Diseases 12(1), 2018
SITE READINESS
Advisory boards are essential to the success of research trials as they help build and sustain overall support from communities affected by the study. How do you create and manage advisory boards?
SOP 101 Community Advisory Board
SOP 102 Implementation Science Advisory Board
Stakeholder mapping is undertaken to identify individuals who influence or are affected by implementation of community-wide MDA for STH. How do you create a stakeholder map?
SOP 103 Baseline Stakeholder mapping
Pre-trial sensitisation encourages maximum support and engagement in the trial by stakeholders. How are sensitisation activities executed?
SOP 104 Pre-trial sensitisation
Benin radio announcement (French .mp3)
Benin radio announcement (English translation .pdf)
Benin newspaper article (French and English translation .pdf) - Fraternité 13/12/2017
Benin newspaper article (French and English translation .pdf) - La Nation 13/12/2017
Study supplies should be available in good time and in good condition. How do we procure, order, store and keep an inventory to ensure efficient study supply use?
SOP 105 Study supplies procurement, ordering, storage, and inventory
Staff recruitment should be handled in a transparent, objective and equitable manner. How do we recruit staff to ensure the best applicants are chosen to meet the need of the trial?
CENSUS AND CLUSTER DEMARCATION
A baseline census is done so that at the end of the trial the results can be compared to see what has changed. The census also allows the households to be divided into clusters - the intervention arm and the control arm - based on baseline infection prevalence.
Informed consent must be obtained from eligible participants before starting the trial. How do we ensure we have informed consent?
SOP 201 Census informed consent
A baseline census is carried out to quantify the population size of the trial site and to establish a socio-demographic database to create a sampling frame and inform cluster demarcation. How is the census administered in the community?
SOP 202 Administrating the baseline census
SOP 203 Administrating the census update
All schools within the trial boundaries are surveyed to create a cluster school database and assess the presence and status of WASH facilities. How is a school facility survey administered?
LONGITUDINAL MONITORING SURVEY
As with the baseline census, informed consent must be received from eligible participants. Data from stool samples collected at time points in the longitudinal cohorts will assess rates of change in STH prevalence, quantify reinfection and validate the models. How is the baseline longitudinal monitoring survey administered?
SOP 303 Administering the first longitudinal monitoring survey (incl eligibility and consent)
What are the procedures for treating individuals in control clusters identified as positive cases (children with any intensity STH infection and adults with moderate to high intensity STH infection)?
SOP 304 Follow-up procedures with positive cases
SOP 305 Administering follow-up longitudinal monitoring surveys
MODELLING
An all-in-one python class for the stochastic modelling of transmission and treatment of Soil-Transmitted Helminthiasis (STH) developed by Imperial College London can be found here.
CROSS-SECTIONAL MONITORING SURVEY
At three points during the study period, a cross-sectional survey of randomly selected participants is undertaken with new selection taking place each time. How are the cross-sectional surveys administered?
MDA DELIVERY AND COVERAGE SURVEY
How do we ensure participation from the community?
SOP 503 Sensitisation and IEC for community-based deworming
Who is eligible for treatment?
SOP 506 Pre-MDA screening for treatment eligibility during community-wide treatment
How is albendazole distributed in communities?
SOP 507 Administration of albendazole in communities
How is albendazole distributed in schools?
SOP 508 Administration of albendazole in schools
How is the treatment data captured digitally?
SOP 509 Completion of the SurveyCTO MDA treatment log
SOP 510 Completion of the SurveyCTO MDA2 treatment log
What happens when there is an adverse event?
SOP 511 Surveillance/reporting of adverse events and serious adverse events
Once the MDA is completed, a survey must be taken to ensure high participation rates. How is the coverage survey administrated?
LAB WORK
How are sample aliquots prepared?
SOP 706 Stool sample reception, aliquoting and storage
How are samples prepared for Kato Katz?
SOP 707 Kato Katz preparation and analysis (prevalence, intensity, and fertilized eggs)
IMPLEMENTATION SCIENCE
Implementation Science is run co-currently with the trial protocol. The study involves working in-country to identify barriers to research uptake.
Systematic participant selection is vital to attain and evaluate a representative set of perspectives, experiences, and opinions. How do we select participants?
SOP 801 Participant selection for individual interviews
SOP 802 Participant selection for focus group discussions
SOP 807 Participant selection for structural readiness survey
Informed consent must be obtained from eligible participants before starting the trial. How do we ensure we have informed consent?
SOP 803 Individual interviews informed consent
SOP 804 Focus group discussions informed consent
Focus groups and individual interviews are used to collect descriptive data regarding a specific topic. How do we ensure we collect data using the same procedures across all interviews and groups?
SOP 805 Conducting focus group discussions
SOP 806 Conducting individual interviews
Structural readiness drives the psychological readiness of different stakeholders in the health system to implement community-wide MDA. How to we survey the 'readiness' of stakeholders?
SOP 808 Conducting structural readiness surveys
In order to better understand the way in which MDA is delivered in each cluster, process mapping takes place in all clusters following each round of MDA. In-depth process mapping is undertaken in six of these clusters. How do we choose the six clusters in which do conduct in-depth process mapping?
SOP 809 Cluster selection for indepth process mapping
Once the clusters are chosen for in-depth process mapping, activities are carried out in conjunction with relevant Ministries. How do we conduct in-depth process mapping?
SOP 810 Conducting indepth process mapping
How are routine workflow tracking worksheets completed in each cluster?
SOP 811 Conducting routine workflow tracking worksheets
How do we collect and compile financial cost data?
How do we collect data about project workers?
SOP 813 Collecting demographic information from project workers
How do we complete a stakeholder mapping exercise?
SOP 814 Endline Stakeholder Mapping
How do we select participants for midline and endline qualitative research?
SOP 815 Participant selection for midline and endline qualitative research
DATA MANAGEMENT
How do data managers initialize data collection devices and provide settings for the mobile devices and data collection application, SurveyCTO Collect?
SOP 901 SurveyCTO installation and Set Up on Smartphones
How do data managers print household ID stickers for the baseline census, individual sampling and census updates?
SOP 902 Printing of household ID barcodes
Site registries are required for the population of the SurveyCTO surveys. These registries include the Field Officer Registry, Village Registry, and School Registry. How are the registries loaded into the SurveyCTO forms?
SOP 903 Creating site registries for populating SurveyCTO surveys
Census and survey data are used to visualise households during activities using the software QGIS. How are the geopoints mapped in QGIS from the census data?