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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tuberculosis
• Intervention / Treatment: Other: Call for Life Uganda

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 274
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dathan M Byonanebye, MBChB,M.MED; Phone Number: +256777913313; Email: byonanebyemd@gmail.com
• Study Contact Backup: Name: Rosalind P Ratanshi, MMBS,PhDFRCP; Phone Number: +256752323253; Email: rp549@medschl.cam.ac.uk

Study Locations

• Uganda
  • Kampala, Uganda
    • Recruiting
    • Kasangati Health Centre IV
    • Contact: Mackline Hope, MBcHB; Phone Number: +256772659941; Email: hmacjkline@idi.co.ug
  • Kampala, Uganda
    • Recruiting
    • Kisenyi Health Centre IV
    • Contact: Mackline Hope, MBcHB; Phone Number: +256772659941; Email: hmackline@idi.co.ug
  • Kiryandongo, Uganda
    • Recruiting
    • Kiryandongo Hospital
    • Contact: Mackline Hope, MBcHB; Phone Number: +256772659941; Email: hmackline@idi.co.ug

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention; 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; 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.; Other Names: CONNECT FOR LIFE
NO_INTERVENTION: Standard; These participants will receive the standard of care according to Uganda National Tuberculosis Treatment guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Makerere University
• Investigators: Principal Investigator: Dathan Byonanebye Mirembe, MBChB, M.MED, Infectious Diseases Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2020
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (ACTUAL): January 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: mHealth; Tuberculosis; TB
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: ST/263/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No