TB MONITORING ADHERENCE AND TREATMENT ENDPOINTS PROJECT:

Conditions

Tuberculosis

Adrian Steulet, Piotr Hippner, Noriah Maraba, Lauren Jennings, Israel Rabothata et al. (12 authors)

BMC Infectious Diseases2026-01-07

Treatment adherence and clinical outcomes amongst in people with drug-susceptible tuberculosis using medication monitor and differentiated care approach compared with standard of care in South Africa: a cluster randomized trial.

Charalambous S, Maraba N, Jennings L, Rabothata I, Cogill D, Mukora R, Hippner P, Naidoo P, Xaba N, Mchunu L, Velen K, Orrell C, Fielding KL.

2024-07-2712 citations

10.1016/j.eclinm.2024.102745

Qualitative study exploring the feasibility of using medication monitors and a differentiated care approach to support adherence among people receiving TB treatment in South Africa

Rachel Mukora, Noriah Maraba, Catherine Orrell, Lauren Jennings, Pren Naidoo et al. (10 authors)

BMJ Open2023-03-0117 citations

10.1136/bmjopen-2022-065202

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.

Maraba N, Orrell C, Chetty-Makkan CM, Velen K, Mukora R, Page-Shipp L, Naidoo P, Mbatha MT, Fielding KL, Charalambous S.

2021-06-0910 citations

10.1186/s13063-021-05337-y

Interventions

medical monitor EvriMed Device and differentiated care approach

Enhanced standard of care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients (children and adults) either initiating or started TB treatment within the last 7 days at selected health facilities Adults willing and able to provide written informed consent to participate , and children, whose caregiver is willing and able to provide assent for participation Patients agree to use the Wisepill evriMED device and to have follow up including text messaging and phone calls Living within the study area and willing to inform the study team of any change of address during the treatment and follow-up period

Exclusion criteria

Exclusion criteria: Drug-resistant TB patients Patients/carer of patient cannot use the Wisepill evriMed device after training patient/care of patient does not have a functional mobile phone

Design outcomes

Primary

Measure	Time frame
The primary study endpoint for treatment adherence will be the percentage of patient-months where at least 20% of doses (equivalent to missing three of 15 doses) were missed (“poor adherence”).	—

Secondary

Measure	Time frame
Treatment success which will be measured as the proportion of patients that either have a documented cure or treatment completion by 210 days following commencement of TB treatment. We will aim to do a TB culture at the end of treatment to determine response to treatment.;TB recurrence effectiveness which will be defined as incidence of TB cases one year post intervention meeting, in patients enrolled in intervention clinics compared to SOC clinics. The definition for • Confirmed tuberculosis: Culture-positive, Xpert MTB/RIF-positive, or smear-positive for M. tuberculosis from any site in adults and children • Clinical tuberculosis: Started on treatment for TB in adults and children	—

Measure

Time frame

Treatment success which will be measured as the proportion of patients that either have a documented cure or treatment completion by 210 days following commencement of TB treatment. We will aim to do a TB culture at the end of treatment to determine response to treatment.;TB recurrence effectiveness which will be defined as incidence of TB cases one year post intervention meeting, in patients enrolled in intervention clinics compared to SOC clinics. The definition for • Confirmed tuberculosis: Culture-positive, Xpert MTB/RIF-positive, or smear-positive for M. tuberculosis from any site in adults and children • Clinical tuberculosis: Started on treatment for TB in adults and children

—

Countries

South Africa

Contacts

Public ContactRene Wills

Regulatory Manager

rwills@auruminstitute.org+270105901399

Outcome results

None listed