Table 2 Summary of activities in the intervention and standard of care arms
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 6Â 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 |