Clinical trial NCT04709159: Impact of Mobile Health Interactive Software on Tuberculosis Outcomes; The Call for Life (CFLU-TB) Project
Official title: Impact of Mobile Health Interactive Software on Tuberculosis Treatment Outcomes: The Call for Life (CFLU-TB) Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis
Keywords: mHealth
Tuberculosis
TB
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment success
timeFrame: After 6 months of treatment
Secondary outcomes:
measure: TB cure for patients with bacteriologically diagnosed TB
timeFrame: After 6 months of treatment
measure: Treatment completion for patients with clinically diagnosed TB
timeFrame: After 6 months of treatment
measure: Retention in care
timeFrame: At 2 and 6 months
measure: Experiences of patients and care providers towards CFLU™
timeFrame: At baseline, 2 months and 6 months
measure: Cost effectiveness of the CFLU™ intervention
timeFrame: At 6 months
measure: Adherence to TB medicines
timeFrame: At 2 months and 6 months
measure: Appointment keeping
timeFrame: At 2 months and 6 months
measure: Knowledge about HIV/TB
timeFrame: Continuous variable
measure: Drug resistant TB rates
timeFrame: At 5 months and 6 months
measure: Uptake of intervention
timeFrame: At 2 months, 4 months and 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Kasangati Health Centre IV
city: Kampala
country: Uganda
facility: Kisenyi Health Centre IV
city: Kiryandongo
country: Uganda
facility: Kiryandongo Hospital
Study officials:
affiliation: Infectious Diseases Institute
name: Dathan Byonanebye Mirembe, MBChB, M.MED
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.