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Table 2 Summary of activities in the intervention and standard of care arms

From: Evaluation of implementation and effectiveness of digital adherence technology with differentiated care to support tuberculosis treatment adherence and improve treatment outcomes in Ethiopia: a study protocol for a cluster randomised trial

Activities Intervention arms Standard of Care arm
Counselling for TB adherence at treatment start Patient education on adherence counselling will be provided as per standard of care Patient education on adherence counselling will be provided as per standard of care
Registration and informed consent [research activity] Adult patients satisfying the inclusion criteria and who consent to be enrolled into the study will provide written informed consent
Patient will be registered on ASCENT adherence platform and upon registration receive confirmation verbally and/or by text message
Adult patients satisfying the inclusion criteria and who consent to be enrolled into the study will provide written informed consent
Data collection for the socio-demographic case report [research activity] Tool delivered by the HCW Tool delivered by the HCW
Explain DAT as a support tool for intervention Delivered by HCW (standardised script) and pictorial booklet Not applicable
TB treatment supervision Self-administration of TB medication with support of DAT As per standard of care (DOT at health facility or patient’ home or workplace, or self-administration)
TB medication provision As per standard of care As per standard of care
Daily dosing reminder A reminder message to patient will be sent if a dose was not recorded on the platform*
Depending on patient preference, the smart pill box can also remind participants using LED and/or sound
No reminder
Follow-up visits for treatment Participants will be provided a return date to visit the health facility for refill As per standard of care in the facility
Follow-up visit for treatment reminders Depending on the DAT-, patient- and HCW preferences, participants can receive a reminder for follow-up visit via text message* or via smart pill box No reminder
Adherence data Information on adherence will be collected via the DAT and available via the ASCENT adherence platform to health HCW As per standard of care (pill counts, patient treatment cards, etc.). Daily adherence data will only be available from those undergoing the facility-based DOT
Follow up visit during treatment HCWs have access to the ASCENT adherence platform and will use the patient’ adherence calendar for counselling
Routine sputum collection at 2, 5 and 6 months
As per standard of care in the facility
Routine sputum collection at 2, 5 and 6 months
Education and motivational messages Participants can receive periodic educational and motivational messages* None
Telephone follow up 6 months after the end of treatment Participants will be telephoned by research staff and a brief questionnaire conducted to ascertain if TB treatment has been restarted since the end of treatment* (among those eligible) Participants will be telephoned by research staff and a brief questionnaire conducted to ascertain if TB treatment has been restarted since the end of treatment* (among those eligible)
Follow up visit 6 months after the end of treatment for sputum collection Participants will be reminded of their appointment 2–3 days before the scheduled date (among those eligible). On attendance at the facility (same as the enrolment facility) sputum will be collected by the HCW for culture Participants will be reminded of their appointment 2–3 days before the scheduled date (among those eligible). On attendance at the facility (same as the enrolment facility) sputum will be collected by the HCW for culture
  1. *Among patients with a mobile phone