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Table 4 Visiting schedule and procedures for contacts

From: Cascade Immune Mechanisms of Protection against Mycobacterium tuberculosis (IMPAc-TB): study protocol for the Household Contact Study in the Western Cape, South Africa

 

Screening and enrolment

Visit 1

Visit 2

Visit 3

Contact 1

3-monthly follow up call (Group 8 only)

Study day

Day 0

M 3–7 days

M3 PET-CT

M3 + 7–14 days (Bronchoscopy)

72 h and day 14 post bronchoscopy

Telephonic/home visit follow up

Informed consent

including bronchoscopy, PET-CT, and genetic testing

x

     

Inclusion/exclusion criteria

x

     

Targeted physical examination

x

  

x

 

xd

TB symptom screen

x

x

   

x

Vital signs and medical history

x

 

x

x

  

Concomitant medications

x

     

Chest x-ray

x

    

xd

ECG (If clinically indicated)

   

x

  

IGRA

x

x

    

Finger prick blood (Hb, random glucose, HbA1c, if indicated)

x

 

xb

   

HIV-1 test and counselling

x

     

Sputum

(GeneXpert® & MGIT)

x

xa

   

xd

PAXgene®

   

x

  

Urine βHCG (all females)

x

 

x

xc

  

NaHep (PBMC)

  

x

x

  

Bronchoscopy (BAL)

   

xe

  

Serum

x

(SARS-CoV-2 serology)

x

(storage)

x

(SARS-CoV-2 serology)

x

  

Nasopharyngeal Swab (for SARS-CoV-2 PCR & respiratory pathogen assays)

  

x

   

PET-CT

  

x

   

Phone call and symptom check

    

x

 
  1. aGeneXpert® only for participants with new TB symptoms
  2. bOnly POC fasting glucose on PET-CT visit
  3. cIf not done within the last 14 days
  4. dOnly if TB symptom screen positive
  5. eParticipants testing SARS CoV 2 PCR positive at visit 2 will have bronchoscopy delayed until 14 days after clinical recovery or PCR negative test, whichever is longer