TB MONITORING ADHERENCE AND TREATMENT ENDPOINTS PROJECT:
Not Applicable
- Conditions
- Tuberculosis
- Registration Number
- PACTR201902681157721
- Lead Sponsor
- Bill and Melinda Gates Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 2610
Inclusion Criteria
All patients (children and adults) either initiating or started TB treatment within the last 7 days at selected health facilities
Adults willing and able to provide written informed consent to participate , and children, whose caregiver is willing and able to provide assent for participation
Patients agree to use the Wisepill evriMED device and to have follow up including text messaging and phone calls
Living within the study area and willing to inform the study team of any change of address during the treatment and follow-up period
Exclusion Criteria
Drug-resistant TB patients
Patients/carer of patient cannot use the Wisepill evriMed device after training
patient/care of patient does not have a functional mobile phone
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study endpoint for treatment adherence will be the percentage of patient-months where at least 20% of doses (equivalent to missing three of 15 doses) were missed (poor adherence”).
- Secondary Outcome Measures
Name Time Method Treatment success which will be measured as the proportion of patients that either have a documented cure or treatment completion by 210 days following commencement of TB treatment. We will aim to do a TB culture at the end of treatment to determine response to treatment.;TB recurrence effectiveness which will be defined as incidence of TB cases one year post intervention meeting, in patients enrolled in intervention clinics compared to SOC clinics. The definition for<br>•Confirmed tuberculosis: Culture-positive, Xpert MTB/RIF-positive, or smear-positive for M. tuberculosis from any site in adults and children<br>•Clinical tuberculosis: Started on treatment for TB in adults and children