An interventional study of Call for Life Uganda in Tuberculosis, sponsored by Makerere University. Status unknown at 3 sites in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by Makerere University · Not applicable, Interventional, and Supportive care
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 Tuberculosis receiving care at three public health facilities, Kisenyi Health Centre IV, Kasangati Health Centre IV and Kiryandongo government Hospital.
Call for Life TB will employ a mobile health Health technology called CONNECT FOR LIFE™ to provide SMS or Interactive Voice Response patient support. This support will be in the form of clinic appointment, daily pill reminders, reminders, health tips and an opportunity to report symptoms which are responded to by a call from study doctors.
Collectively, 274 patients will be randomized (1:1ratio) to Intervention Arm (daily adherence calls, a pre-appointment reminder call, health tips and 24hr symptom reporting) or Standard of care (standard practice according to the national guidelines for TB treatment). Call for Life TB will also provide for Treatment supporters of patients on the Intervention Arm to be co-registered onto the system so as to enhance Directly Observed Treatment (DOTS).
Participants will be followed up for 6 months and observational data collected at several points. Data on sociodemographics, treatment response/outcome determined at 2 and at the end of treatment. Investigators shall conduct Focus Group Discussions (FGDs) and In- Depth Interviews (IDIs) with patients and clinic staff respectively, on ease of use, acceptability and satisfaction with the intervention.
Investigators will use system data to assess uptake and adherence to the tool. Investigators shall determine differences in the proportions of patients with treatment success in the two arms. Additionally, investigators shall assess adherence to medication, TB cure rates and treatment completion. Investigators shall qualitatively determine, perception, acceptability, and satisfaction with CFLU-TB. As a measure of cost-effectiveness, investigators shall determine marginal cost effectiveness CFLU-TB with regard to treatment success. The proposed study endpoint is 6-months retention in care, treatment and appointment adherence.
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 Uganda.
Secondary Objectives
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's planned enrollment of 274 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Makerere University is the lead sponsor of 143 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants on this arm will use Interactive Voice Response (IVR) daily pill reminders, thrice-weekly health messages, clinic appointment reminders, remote symptom reporting service and a 24 hour toll-free number to access services. These participants will also have the option to co-register a caregiver who will also receive daily pill reminders, clinic appointment reminder, weekly health tips and remote symptom reporting service. In addition, these participants will receive the standard of care according to Uganda National Tuberculosis Treatment guidelines.
Other: Call for Life Uganda
These participants will receive the standard of care according to Uganda National Tuberculosis Treatment guidelines.
Call for Life™ Uganda (C4LU) is a web-based mHealth tool that provides treatment support to patients in the form of daily or weekly pill adherence reminders, health messages, clinic appointment reminders and a remote symptom reporting service. The tool interacts with patients by text message (SMS) or using voice and tone input via keypad (Interactive Voice Response - IVR) on both analogue and smart phones. The tool uses CONNECT FOR LIFE technology, which is on an open source platform developed by Grameen Foundation and the University of Southern Maine with financial support from the Bill and Melinda Gates Foundation. It was supported by Janssen, the Pharmaceutical Companies of Johnson and Johnson and was released under the terms of the MOTECH open source license agreement.
Also known as: CONNECT FOR LIFE
Treatment success
Percentage of patients with treatment success. Treatment success is the sum of the percentages of patients declared cured and those who complete treatment.
Time frame: After 6 months of treatment
TB cure for patients with bacteriologically diagnosed TB
Percentage of cured patients. TB cure is a pulmonary TB patient with bacteriologically confirmed TB at the beginning of treatment who was smear- or culture-negative in the last month of treatment and on at least one previous occasion.
Time frame: After 6 months of treatment
Treatment completion for patients with clinically diagnosed TB
Percentage of patients who complete treatment.Treatment completion is a TB patient who completed treatment without evidence of failure BUT with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative, either because tests were not done or because results are unavailable.
Time frame: After 6 months of treatment
Retention in care
Percentage of patients active in care. Retention in care is evidence of a clinic visit within 30 days of last visit appointment.
Time frame: At 2 and 6 months
Experiences of patients and care providers towards CFLU™
Themes discussed through Focus Group Discussions and In-Depth Interviews
Time frame: At baseline, 2 months and 6 months
Cost effectiveness of the CFLU™ intervention
Incremental cost per additional DALY averted as a result of improvement in treatment success using governmental and societal perspective
Time frame: At 6 months
Adherence to TB medicines
Mean adherence rates (proportion of TB medicines taken as evidenced by TB card
Time frame: At 2 months and 6 months
Appointment keeping
Proportions of patients who keep their appointment; proportions of early, on-time and late appointments)
Time frame: At 2 months and 6 months
Knowledge about HIV/TB
Mean increase in knowledge about TB/HIV
Time frame: Continuous variable
Drug resistant TB rates
Absolute numbers and proportions of patients with Rifampicin resistance by GeneXpert
Time frame: At 5 months and 6 months
Uptake of intervention
Mean call success rate
Time frame: At 2 months, 4 months and 6 months
Plan to share: No
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Makerere University