Research tool kit

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. As the trial is ongoing, please check in regularly for updated documents.

DeWorm3_SOP_timeline-two-column

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?

SOP 106 Recruitment procedures

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?

SOP 204 Administrating the school facility survey

Following the baseline population census, cluster boundaries can be defined. How are cluster boundaries established?

SOP 205 Establishing cluster boundaries

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)

SOP 305 Administering follow-up longitudinal monitoring surveys

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?

SOP 403 Administering the baseline cross-sectional survey
SOP 405 Follow-up procedures with positive cases (adults with mod/heavy intensity infections in control arms)
SOP 406 Administering follow-up cross sectional surveys

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

How is albendazole distributed in communities?

SOP 507 Administration of albendazole in communities

How is the treatment data captured digitally?

SOP 509 Completion of the CW-MDA SurveyCTO Treatment Forms

How is albendazole distributed in schools?

SOP 510 Administration of albendazole in schools

What happens when there is an adverse event?

SOP 511 Adverse event, serious adverse event reporting

Once the MDA is completed, a survey must be taken to ensure high participation rates. How is the coverage survey administrated?

SOP 512 Administration of coverage survey

SPECIMAN COLLECTION AND SHIPMENT

How are samples packaged?

SOP 603 Sample packaging and shipment (10% QC check)

How are samples collected?

SOP 604 Dry blood spot collection (final follow-up survey)

LAB WORK

How are sample aliquots prepared?

SOP 706 Stool sample aliquoting and storage

How are samples prepared for Kato Katz?

SOP 707 Kato Katz preparation and analysis (prevalence, intensity, and fertilized eggs)

What are the lab procedures?

SOP 710 Primer quality control 
SOP 711 DNA isolation
SOP 712 qPCR procedures
SOP 713 Resistance Monitoring

How to we maintain quality control?

SOP 714 Preparation for shipping samples for QA/QC
SOP 715 Corrective action in quality control
SOP 716 Internal QA/QC procedures
SOP 717 External QA/QC procedures

How do we test for morbidity?

SOP 718 Dry blood spot analysis

How do we check treatment coverage?

SOP 719 Urine analysis

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?

SOP 812 Cost collection

How do we collect data about project workers?

SOP 813 Collecting demographic information from project workers

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? 

SOP 904 Mapping geopoints in QGIS

SOP 906 Cluster randomization codes

SOP 907 Data management QA/QC

SOP 908 Random selection of barcode samples for KK

SOP 909 Randomization process for longitudinal monitoring survey

SOP 910 Random selection of participants for the cross-sectional survey

SOP 911 Randomization process for coverage survey