Impact of Mobile Health Interactive Software on Tuberculosis Outcomes; The Call for Life (CFLU-TB) Project
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Tuberculosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 diag...
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.
Tracking Information
- NCT #
- NCT04709159
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dathan Byonanebye Mirembe, MBChB, M.MED Infectious Diseases Institute
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