Assessing the feasibility, acceptability and impact of a conversational mhealth platform supporting TB treatment adherence

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202501746484460

Enrollment

1000

Registered

2025-01-30

Start date

2025-02-03

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Tuberculosis

Interventions

Control group

Treatment group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients newly diagnosed (treatment naive) with pulmonary DS TB (Based on culture test) Own a (smart) mobile phone (for intervention sample) Age 18 or older Able to understand written and verbal information regarding the study (documents will be available in English, Afrikaans and isiXhosa) Able to give written informed consent

Exclusion criteria

Exclusion criteria: Patients with extrapulmonary TB Patients with multidrug-resistant TB Patients with co-morbidities requiring substantial additional acute medical, or psychiatric intervention Patients younger than 18 Patients unable to understand written or verbal information regarding the study

Design outcomes

Primary

Measure	Time frame
The difference in proportion of patients with adverse outcomes at the end of treatment. The outcomes are mortality, loss to follow up based on routine data and culture positivity within the last month of treatment	—

Secondary

Measure	Time frame
Understanding of the feasibility, acceptability, and fidelity of use of the interventions and the extent to which these meet patients' needs.;Difference in the cost per patient treated and successfully treated between study arms;Cure. Patient whose baseline smear (or culture) was positive at the beginning of treatment and is smear (or culture) negative in the last month of treatment and on at least one previous occasion at least 30 days prior. Captured via routine data and complemented with laboratory data.;Treatment Completed. Patient with no baseline smear (or culture) or whose baseline smear (or culture) was positive at the beginning and has completed treatment but does not have a negative smear (or culture) in the last month of treatment and on at least one previous occasion more than 30 days prior. Captured via routine data and complemented with laboratory data.;Mortality. Patient who dies for any reason during the course of TB treatment. Deaths captured via routine data.;Treatment failure. Patient whose baseline culture was positive and remains or becomes positive again at 5 months or later during treatment. Captured via routine data and complemented with laboratory data.;Loss to follow up. Patient whose treatment was interrupted for two consecutive months or more during the treatment period. Captured via routine data and complemented by PHDC data to track silent transfers;Nucleic acid amplification test result, and or smear and or culture status;Smear and or culture status ;Quality of Life. Complete validated WHOQOL-BREF questionnaire (0, 5m; physical, psychological, social relationships, and environmental health domains);Wellness check questionnaire;Lung function - 3 minute test;Karnofsky Performance Score;TB Score I and II ;HIV/ART status;CD4 count;% doses taken based on box-opening from silent MERM;Estimated number of missed doses based on late collection / missed appointment;Estimate missed doses from remaining doses projected vs actual;Self-reported medi	—

Measure

Time frame

Understanding of the feasibility, acceptability, and fidelity of use of the interventions and the extent to which these meet patients' needs.;Difference in the cost per patient treated and successfully treated between study arms;Cure. Patient whose baseline smear (or culture) was positive at the beginning of treatment and is smear (or culture) negative in the last month of treatment and on at least one previous occasion at least 30 days prior. Captured via routine data and complemented with laboratory data.;Treatment Completed. Patient with no baseline smear (or culture) or whose baseline smear (or culture) was positive at the beginning and has completed treatment but does not have a negative smear (or culture) in the last month of treatment and on at least one previous occasion more than 30 days prior. Captured via routine data and complemented with laboratory data.;Mortality. Patient who dies for any reason during the course of TB treatment. Deaths captured via routine data.;Treatment failure. Patient whose baseline culture was positive and remains or becomes positive again at 5 months or later during treatment. Captured via routine data and complemented with laboratory data.;Loss to follow up. Patient whose treatment was interrupted for two consecutive months or more during the treatment period. Captured via routine data and complemented by PHDC data to track silent transfers;Nucleic acid amplification test result, and or smear and or culture status;Smear and or culture status ;Quality of Life. Complete validated WHOQOL-BREF questionnaire (0, 5m; physical, psychological, social relationships, and environmental health domains);Wellness check questionnaire;Lung function - 3 minute test;Karnofsky Performance Score;TB Score I and II ;HIV/ART status;CD4 count;% doses taken based on box-opening from silent MERM;Estimated number of missed doses based on late collection / missed appointment;Estimate missed doses from remaining doses projected vs actual;Self-reported medi

—

Countries

South Africa

Contacts

Public ContactRonelle Burger

Professor Stellenbosch University

rburger@sun.ac.za+27218083106

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026