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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 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. |
|
| Standard | No Intervention | These participants will receive the standard of care according to Uganda National Tuberculosis Treatment guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Call for Life Uganda | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 6 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dathan M Byonanebye, MBChB,M.MED | Contact | +256777913313 | byonanebyemd@gmail.com | |
| Rosalind P Ratanshi, MMBS,PhDFRCP | Contact | +256752323253 | rp549@medschl.cam.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Dathan Byonanebye Mirembe, MBChB, M.MED | Infectious Diseases Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasangati Health Centre IV | Recruiting | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34120649 | Derived | Byonanebye DM, Mackline H, Sekaggya-Wiltshire C, Kiragga AN, Lamorde M, Oseku E, King R, Parkes-Ratanshi R. Impact of a mobile phone-based interactive voice response software on tuberculosis treatment outcomes in Uganda (CFL-TB): a protocol for a randomized controlled trial. Trials. 2021 Jun 13;22(1):391. doi: 10.1186/s13063-021-05352-z. |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D019002 | CD56 Antigen |
| ID | Term |
|---|---|
| D019006 | Neural Cell Adhesion Molecules |
| D015816 | Cell Adhesion Molecules, Neuronal |
| D015815 | Cell Adhesion Molecules |
| D008562 | Membrane Glycoproteins |
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Randomized Controlled Trial with two arms. Interventional Arm will receive the intervention (daily pill reminders, health messages, clinic appointment reminders, remote symptom reporting service, toll-free number to call in to receive services, plus the option to co-register a caregiver who will receive the same services as the patient) as well as standard of care. The Control arm will have patients who will receive only standard of care available at the TB clinics as per the Uganda National Tuberculosis Treatment guidelines.
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|
| 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. |
| 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. | At 2 and 6 months |
| Experiences of patients and care providers towards CFLU™ | Themes discussed through Focus Group Discussions and In-Depth Interviews | 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 | At 6 months |
| Adherence to TB medicines | Mean adherence rates (proportion of TB medicines taken as evidenced by TB card | At 2 months and 6 months |
| Appointment keeping | Proportions of patients who keep their appointment; proportions of early, on-time and late appointments) | At 2 months and 6 months |
| Knowledge about HIV/TB | Mean increase in knowledge about TB/HIV | Continuous variable |
| Drug resistant TB rates | Absolute numbers and proportions of patients with Rifampicin resistance by GeneXpert | At 5 months and 6 months |
| Uptake of intervention | Mean call success rate | At 2 months, 4 months and 6 months |
| Kisenyi Health Centre IV | Recruiting | Kampala | Uganda |
|
| Kiryandongo Hospital | Recruiting | Kiryandongo | Uganda |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D000945 | Antigens, Differentiation, T-Lymphocyte |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D015415 | Biomarkers |