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

Phase

N/A

Condition

Hiv

Lung Disease

Treatment

N/A

Clinical Study ID

NCT04709159

ST/263/2020

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Evidence of TB diagnosis-either confirmed bacteriologically by Xpert MTB/RIF VersionG4 assay (Cepheid, Sunnyvale, CA, USA) or clinically diagnosed by health worker.
Evidence of a personally signed and dated informed consent document indicating thatthe participant (or a legal representative) has been informed of all pertinent aspectsof the study.
Willingness to comply with scheduled visits, treatment plan, laboratory tests, andother study procedures.
Aged 18 years or more
Mobile phone ownership
Patients who can understand Luganda, Runyankole, Swahili or English. These languagesare the languages spoken by of the majority of patients at three health. Otherlanguages may be added to the service if the anticipated demand surpasses 30 patients.

Exclusion

Exclusion Criteria:

Patient unable to use a basic feature phone or who whose clinical condition thatinterferes with appropriate use of cell phone for voice calls (e.g., deafness, severecognitive impairment)
Ongoing participation in another interventional study that the investigator believeswill 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 andExtensive drug resistant TB).
Patients with TB Meningitis or Osteoarticular TB.
Any other clinical condition that, in the opinion of the site investigator, would makethe participant unsuitable for the study or unable to meet with dosing requirements.

Study Design

October 19, 2020

July 31, 2022

Study 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

To compare TB cure rates (six months) in patients with microbiologically diagnosed TB.
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.
To assess views of care-providers towards the CFLU-TB.
To assess the cost-effectiveness of the CFLU-TB intervention in TB care
To determine and compare adherence rates between patients in the intervention arm and control arms.
To compare treatment completion (six months) in patients clinically diagnosed with TB in the intervention and control arms.
To compare knowledge about TB/HIV in patients enrolled in the intervention and control arms.
To determine the effect of CFLU-TB on adherence to clinic appointments.
To determine the level of usage of the CFLU-TB tool in patients and their care providers
To determine rifampicin-resistance rates in the intervention and control arms.

Connect with a study center

Kasangati Health Centre IV
Kampala,
Uganda
Active - Recruiting
Kisenyi Health Centre IV
Kampala,
Uganda
Active - Recruiting
Kiryandongo Hospital
Kiryandongo,
Uganda
Active - Recruiting

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