Status:
UNKNOWN
Impact of Mobile Health Interactive Software on Tuberculosis Outcomes; The Call for Life (CFLU-TB) Project
Lead Sponsor:
Makerere University
Conditions:
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will be an open-label Randomized Controlled Trial (RCT) to determine the effect of Call for Life TB (CFLU-TB) on Tuberculosis (TB) treatment success in patients with non-drug resistant Tube...
Detailed Description
Objectives of the study: To determine the effect of CFLU-TB on TB treatment success (treatment completion and cure rates) in patients with TB receiving care at three public health facilities in Ugand...
Eligibility Criteria
Inclusion
- Evidence of TB diagnosis-either confirmed bacteriologically by Xpert MTB/RIF Version G4 assay (Cepheid, Sunnyvale, CA, USA) or clinically diagnosed by health worker.
- Evidence of a personally signed and dated informed consent document indicating that the participant (or a legal representative) has been informed of all pertinent aspects of the study.
- Willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Aged 18 years or more
- Mobile phone ownership
- Patients who can understand Luganda, Runyankole, Swahili or English. These languages are the languages spoken by of the majority of patients at three health. Other languages may be added to the service if the anticipated demand surpasses 30 patients.
Exclusion
- Patient unable to use a basic feature phone or who whose clinical condition that interferes with appropriate use of cell phone for voice calls (e.g., deafness, severe cognitive impairment)
- Ongoing participation in another interventional study that the investigator believes will interfere with study procedures or assessment of outcomes of this study.
- Patients who are critically ill.
- Patients with drug resistant TB (Rifampicin resistant, Multi-drug resistant and Extensive drug resistant TB).
- Patients with TB Meningitis or Osteoarticular TB.
- Any other clinical condition that, in the opinion of the site investigator, would make the participant unsuitable for the study or unable to meet with dosing requirements.
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT04709159
Start Date
October 19 2020
End Date
July 1 2022
Last Update
January 26 2021
Active Locations (3)
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1
Kasangati Health Centre IV
Kampala, Uganda
2
Kisenyi Health Centre IV
Kampala, Uganda
3
Kiryandongo Hospital
Kiryandongo, Uganda