Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 1:19 PM
Study NCT ID:
NCT04709159
Status:
UNKNOWN
Last Update Posted:
2021-01-26
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Mobile Health Interactive Software on Tuberculosis Outcomes; The Call for Life (CFLU-TB) Project
Sponsor:
Makerere University
Organization:
Study Overview
Official Title:
Impact of Mobile Health Interactive Software on Tuberculosis Treatment Outcomes: The Call for Life (CFLU-TB) Project
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CFLU-TB
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: