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Four-country evaluation of digital adherence technologies linked to a web-based platform to support adherence to TB treatment

Adherence Support Coalition to End TB (ASCENT): four-country evaluation of digital adherence technologies for TB treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17706019
Enrollment
46446
Registered
2020-11-18
Start date
2021-01-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Tuberculosis Infections and Infestations Tuberculosis

Interventions

Randomization of the clusters, health facilities or rayons (in Ukraine), to the intervention arm or the standard of care arm in a ratio of 1:1, will be conducted using stratification and restriction i

Sponsors

KNCV TB Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult (based on country) pulmonary DS-TB patients initiated on TB treatment

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
The proportion of adult DS-TB patients with poor end of treatment outcome, defined as having documented treatment failure, lost to follow-up or death as reported in the facility/rayon TB register upon completion of treatment (approximately 6 months)

Secondary

MeasureTime frame
1. The proportion of adult DS-TB patients who are lost to follow-up during treatment as reported in the facility/rayon TB register 6 months after the initiation of therapy 2. Time to treatment completion among DS-TB patients calculated from start and completion date as reported in the facility/rayon TB register upon completion of therapy 3. The proportion of adult DS-TB patients with poor treatment outcomes, as reported in the facility/rayon TB register upon completion of therapy Intervention arm only: 4. Patterns of longitudinal technology engagement in the intensive and continuation phase, to be characterized, at a minimum, as the proportion of days upon completion of a patients treatment phase (intensive and continuation) with a dose being reported (adherence) to the platform 5. The proportion of patient events upon completion of treatment who had a differentiated response (either reminder SMS, home visit or facility visits) due to non-adherence as reported on the platform, among all patients and among non-adherent patients 6. The proportion of patients who received phone calls, home visits, and motivational counselling due to a non-adherence event as reported on the platform over the course of a patients treatment Impact modelling: 7. The change in the number of adult DS-TB patients with poor treatment outcome at the time of treatment completion compared to the current standard of care if the intervention were to be scaled up nationally, projected using simple cohort model using study data 8. The cost-effectiveness of DAT compared to standard of care from health system and societal perspectives, relative to country-specific cost-effectiveness thresholds DR-TB patients: 9. Patterns of longitudinal technology engagement in the intensive and continuation phase to be characterized, at the minimum, as the proportion of days through the end of treatment with a dose being reported (adherence) to the platform 10. The proportion of adult DR-TB patients with poor treat

Countries

Philippines, South Africa, Tanzania, Ukraine

Contacts

Public ContactDegu Jerene Dare
degu.dare@kncvtbc.org+31 (0)682102074

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026