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Community trial of new methods in tuberculosis treatment management

Cluster randomized trial of using mobile text messaging and a medication monitor in tuberculosis (TB) case management

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46846388
Enrollment
4176
Registered
2011-07-21
Start date
2011-06-01
Completion date
Unknown
Last updated
2016-10-17

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

This is a cluster randomised non blinded trial. Clusters are defined as a county or district. This is a four armed trial, three intervention arms and one control arm: 1. Mobile phone Patients are prov

Sponsors

China Center for Disease Control and Prevention (China)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. TB patients, smear-positive or smear-negative, recruited from the study clusters (county/district) 2. Willing to participate in the study 3. Conscious without any mental disease 4. Conscious without any visual, auditory or language impairment 5. At least 18 years old 6. Patient or family member is able to read a short message service (SMS)/ text and use medication monitor after training

Exclusion criteria

Exclusion criteria: 1. Does not meet inclusion criteria 2. Patients with tuberculosis pleurisy 3. Patients with no sputum smear data at tuberculosis diagnosis

Design outcomes

Primary

MeasureTime frame
The mean proportion of months a patient has at least 3 doses missed (this is based on pill count data from the medication monitor box)

Secondary

MeasureTime frame
1. The mean proportion of months a patient has at least 7 doses missed 2. The mean proportion of overall missed doses 3. Proportion of patients defined as non-adherent (at least 10% of doses missed) 4. Proportion of patients defaulting during TB treatment 5. Proportion of smear positive TB cases who become smear negative at 2 months 6. The proportion of patients with treatment outcome of cure or completed treatment

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026