Skip to main content

Table 1 Description of scheduled study visits

From: Evaluation of adherence monitoring system using evriMED with a differentiated response compared to standard of care among drug-sensitive TB patients in three provinces in South Africa: a protocol for a cluster randomised control trial

Study Visit

Month (M) and

Day (D)

D0

(Enrolment)

M1

M2

M3

M4

M5

M6

M9

M12

M15

M18

Informed consent

√

          

Eligibility criteria verified

√

          

Of those eligible:

           

Locator information

√

√

√

√

√

√

√

√

√

√

√

Brief medical history

√

          

Risk assessment for TB

√

          

Economics questions

√

          

Stigma scale

√

     

√

   

√

Facility dispensed treatment

√

√

√

√

√

√

     

Education on the medication monitor and monitor provided to patient

√

          

Medication monitor configured to have visual and audio reminders—intervention arm only

√

          

Participants’ experience using medication monitor and adherence discussion for intervention—intervention arm only

 

√

√

√

√

√

√

    

Social harm

      

√

 

(√*)

  

Pre-treatment, two and five months routine specimens abstracted from record

      

√

    

Treatment completion history abstracted from routine records

      

√

    

TB Symptom screen**

       

√

√

√

√

Research clinic visit

       

√

√

√

√

Sputum culture and GXP

√(*)

     

√

(√)

(√)

(√)

√

  1. GXP Gene Xpert MTB/Rif
  2. (*) collect culture for those who were diagnosed via chest radiograph or clinically or have negative GXP result; **TB investigations performed if participant is symptomatic for TB; (√) sputum collected for culture and GXP if TB symptoms are reported at that visit; (√*) only done if social harm case report form was not completed at month 6