Supplemental Digital Content 2.
SOP Title: TB/Helminth – FIELD WORK- Control child invitation SOP code: BRTC _TBHelminth_002_V01
1.0 Introduction
TB/helminth is a cohort of children exposed and not exposed to sputum smear-positive adult TB cases in Temeke, Dar es Salaam. The study aims at determining the prevalence and intensity of intestinal helminth in children <5 years of age exposed and not exposed to smear-positive TB cases. Furthermore to assess TB and helminths co-infection association with clinical outcomes and TB exposure outcome among children <5 years of age in the Temeke district, Dar es Salaam, Tanzania.
2.0 Objective
The objective of this SOP is to describe the randomization procedures a field worker will do to pick a control household during TB index case household visit when identifying children for possible enrolment into the TB/Helminth study.
3.0 Definition and Abbreviations GPS: Geographical Positioning System ODK: Open Data Kit
SOP: Standard Operation Procedure TB: Tuberculosis
4.0 Scope
This SOP is applicable to all staff involved in field activities such as household visits and acquiring GPS coordinates. The SOP applied to field workers, study secretary and study clinician. The visit will be declared complete when all procedures purposed for that particular visit are done and checklist is completed.
5.0 Responsibilities
The Principal Investigator will have overall responsibility for the procedures in this SOP. The study clinician will supervise the procedures on this SOP. The delegated staff responsible to perform the procedures described will be included in the site Delegation Log.
6.0 Study Procedures
All procedures and findings need to be entered into the Open Data Kit (ODK) to capture all the data generated by the study participants. A visit specific checklist and a sample collection checklist will guide through the procedures and completeness of the visit. Eligible participants who met all inclusion criteria and none of the exclusion criteria as per eligibility criteria will be enrolled into the TB-Dar study.
Visit Day Study Procedures Location Responsible Person
0 1
After visiting the index case household,
Using the sketch below visit the houses in a pattern shown below
Start by visiting the house on the right, number 1-9
Ask for the head of the household
Enquire if there is any one >15 years old on anti-TB medication
If there is, ask about TB treatment card and document Treatment number and thank the interviewee and go to the next house according to the sketch below.
If there is none proceed
Enquire if there is a child 6-59 months old in the household and
Talk to the parent or caretaker of the first under-five mentioned to you
Follow the procedures of SOP BRTC_TBHelminth_001_V01 to proceed with invitation of
parent/caretaker to Temeke District hospital for possible recruitment into the TB/Helminth study
Field Field worker
SDC 2 Figure: A sketch of the view of houses surrounding an index case household to be considered for randomization to recruit a child from a TB free household (Ref. 1).
Reference
1. Grimes DA, Schulz KF. Compared to what? Finding controls for case-control studies. The Lancet. 2005 Apr;365(9468):1429–33.