Tuberculosis
Conditions
Interventions
EvriMed Device medical monitor and differentiated response to patient adherence
medication sleeves or label and differentiated response to patient adherence
Standard of care
Sponsors
KNCV Tuberculosis Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults (=18 years, male and female) with pulmonary DS-TB Adult with pulmonary DS-TB who are initiated on TB treatment using fixed dose combination (FDC) at the health facility Adult with pulmonary DS-TB who have provided informed consent.
Exclusion criteria
Exclusion criteria: Patients who expect to leave the study area at any time during the treatment or follow up period Critically ill patients receiving in-patient care or palliative care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of adult pulmonary DS-TB participants with unfavourable outcome, defined as poor end of treatment outcome (lost to follow-up, death or treatment failure) or treatment recurrence up to 6 months after the scheduled end of treatment (defined as restarting TB treatment or sputum culture positive 12 months after enrolment). Each intervention arm will be compared to the standard of care arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patterns of longitudinal technology engagement in the intensive and continuation phases. ;To describe the fidelity and characteristics associated with successful use of to the intervention among adult pulmonary DS-TB participants, including web-based platform usage statistics, technology failures or inability to engage with the DAT and cell phone access. ;To describe the longitudinal technology engagement (smart pill box and video supported treatment) and interim treatment outcomes among DR-TB participants enrolled;To project the direct and indirect epidemiological impact of scale-up of (i) smart pill box and (ii) medication sleeve, with daily monitoring and differentiated response to patient adherence compared with the standard of care as measured by the change in unfavourable outcome in the intervention relative to the standard of care among adult pulmonary DS-TB participants;To estimate the cost-effectiveness of the two interventions from a health system perspective compared to the standard of care among adult pulmonary DS-TB participants;To explore the institutional feasibility and acceptability of implementing (i) smart pill box and (ii) medication sleeve for daily monitoring, with differentiated response to patient adherence in adult DS-TB and DR-TB participants (smart pill box only). ;The proportion of adult pulmonary DS-TB participants who have poor treatment outcome (lost to follow-up, death during treatment or treatment failure). Each intervention arm will be compared to the standard of care arm. ;The proportion of adult pulmonary DS-TB participants who are lost to follow-up during treatment. Each intervention arm will be compared to the standard of care arm.;The proportion of adult pulmonary DS-TB participants with unfavourable outcome (comparing the two intervention arms). | — |
Countries
Ethiopia
Contacts
Public ContactGediyon Teferra
Acting Manager
Outcome results
None listed