Impact of Mobile Health Interactive Software on Tuberculosis Outcomes; The Call for Life (CFLU-TB) Project

Tuberculosis Clinical Trial

— CFLU-TB  

Official title:

Impact of Mobile Health Interactive Software on Tuberculosis Treatment Outcomes: The Call for Life (CFLU-TB) Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04709159
• Other study ID #: ST/263/2020
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: July 2022

Study information

• Verified date: January 2021
• Source: Makerere University
• Contact: Dathan M Byonanebye, MBChB,M.MED
• Phone: +256777913313
• Email: byonanebyemd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 Uganda. Secondary Objectives 1. To compare TB cure rates (six months) in patients with microbiologically diagnosed TB. 2. To determine the effect of enhanced TB treatment support with CFLU-TB on 2- and 6-month retention in patients receiving TB treatment at Kisenyi Health Center IV. 3. To assess views of care-providers towards the CFLU-TB. 4. To assess the cost-effectiveness of the CFLU-TB intervention in TB care 5. To determine and compare adherence rates between patients in the intervention arm and control arms. 6. To compare treatment completion (six months) in patients clinically diagnosed with TB in the intervention and control arms. 7. To compare knowledge about TB/HIV in patients enrolled in the intervention and control arms. 8. To determine the effect of CFLU-TB on adherence to clinic appointments. 9. To determine the level of usage of the CFLU-TB tool in patients and their care providers 10. To determine rifampicin-resistance rates in the intervention and control arms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• Call for Life Uganda
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.

Locations

Country	Name	City	State
Uganda	Kasangati Health Centre IV	Kampala
Uganda	Kisenyi Health Centre IV	Kampala
Uganda	Kiryandongo Hospital	Kiryandongo

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence to TB medicines	Mean adherence rates (proportion of TB medicines taken as evidenced by TB card	At 2 months and 6 months
Secondary	Appointment keeping	Proportions of patients who keep their appointment; proportions of early, on-time and late appointments)	At 2 months and 6 months
Secondary	Knowledge about HIV/TB	Mean increase in knowledge about TB/HIV	Continuous variable
Secondary	Drug resistant TB rates	Absolute numbers and proportions of patients with Rifampicin resistance by GeneXpert	At 5 months and 6 months
Secondary	Uptake of intervention	Mean call success rate	At 2 months, 4 months and 6 months