Monitoring Patient Compliance With Tuberculosis Treatment Regimens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,207
- Locations
- 11
- Primary Endpoint
- Treatment Outcomes
Study Overview
Brief Summary
In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive Reminders is an interactive SMS reminder system to help patients remember to take their TB medication. In this system, patients receive daily SMS reminders for the duration of their treatment at a pre-specified time, reminding them to take their medication. Patients are asked to reply back to the system, either through SMS or a missed call, with the time they took their medicine that day. If a response is not received within two hours, a second reminder is sent. If a response is still not received in a further two hours, a third and final reminder for the day is sent. Non-responsive patients are followed up with phone calls and a list of non-responsive patients is shared with clinics based on the parameters of non-responsiveness that they specify.
IRD seeks to determine the impact of this system on treatment outcomes and compliance to prescribed medication through administering a randomized control trial among newly diagnosed TB patients in Karachi, Pakistan.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •New, smear-positive drug susceptible TB who have been on treatment for less than two weeks
- •Access to a mobile phone (self-reported)
- •Intending to reside in Karachi for the duration of their treatment
Exclusion Criteria
- •Patients who do not have regular access to a mobile phone
- •Patients who have previously received TB treatment
- •Patients who have another member in their household who is already a part of the study
Arms & Interventions
Control
This arm will receive the regular standard of care given by TB clinics.
Interactive Reminders
Patients randomized to this arm will receive Interactive SMS reminders daily.
Intervention: Interactive Reminders (Other)
Outcomes
Primary Outcomes
Treatment Outcomes
Time Frame: After 6 to 8 months of treatment
The investigators will compare clinically reported treatment outcomes between the intervention and control groups.
Secondary Outcomes
- Physical fitness and mobility(Monthly visits for 6 to 8 months of treatment)
- Psychological Impacts(Monthly visits for 6 to 8 months of treatment)
- Self-reported medication adherence("Surprise" monthly visits during treatment)
- Sputum conversion(At 1, 2, 5, and 6/7 months of treatment)
Investigators
Shama Mohammed
Associate Researcher
Interactive Research and Development