A trial comparing digital tools to help tuberculosis patients complete their treatment in India
| ISRCTN | ISRCTN93928296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93928296 |
| Sponsor | Indian School of Business |
| Funder | Bill and Melinda Gates Foundation |
- Submission date
- 13/08/2026
- Registration date
- 19/08/2026
- Last edited
- 18/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Tuberculosis (TB) is a common infectious disease caused by bacteria that primarily affects the lungs. It affects millions of people each year, with India accounting for a quarter of all TB cases worldwide. Standard treatment is 6 months of daily tablets, but many patients struggle to take them every day. Digital tools are widely used to help patients remember to their tablets and alert health workers to support those patients who have missed their doses. However, there is limited evidence on how well these tools work. This study compares two such commonly used tools, a daily toll-free calling system and a smart pill-box, against a simpler monthly check-in (refill monitoring), to see which best helps patients take their tablets regularly and successfully complete treatment.
Who can participate?
Patients aged 18 years and over with pulmonary TB that responds to standard first-line rifampicin-based treatment
What does the study involve?
Participants are randomly placed into one of three groups, with an equal chance of each:
1. Toll-free calling: call a free number daily after taking tablets
2. Smart pillbox: an alarm-fitted electronic pill-box that logs each opening
3. Refill monitoring (comparison group): call a free number whenever prescription is refilled, typically every month
All groups get the same free tablets, counselling at treatment initiation and follow-up: a phone call if a signal is missed for 3 days, a home visit if missed for 7 days, plus counselling and troubleshooting, if required. Additionally, each participant gets up to three urine tests at random points during treatment. At the end of 6 months, each participant's outcome is recorded based on a survey, and a sputum test.
A separate part of the study looks at why each tool works or doesn't, by interviewing some participants and health workers about their experience. The study also tracks the cost of running each approach.
What are the possible benefits and risks of participating?
Everyone receives the same free treatment and same follow-up support, so any problems can be identified and addressed sooner. Participants also receive free sputum and urine testing as part of the study. There are no notable risks, as the study only adds monitoring and counselling to usual TB care. Participants can switch home visits to phone calls, request a different time or place for follow-up, or decline current or future follow-ups if they find them inconvenient.
Where is the study run from?
Indian School of Business
When is the study starting and how long is it expected to run for?
July 2025 to October 2026
Who is funding the study?
Bill & Melinda Gates Foundation (USA)
Who is the main contact?
Prof. Sarang Deo, sarang_deo@isb.edu
Contact information
Principal investigator, Public, Scientific
Indian School of Business
Hyderabad
500111
India
| Phone | +91 (0)4023187378 |
|---|---|
| sarang_deo@isb.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Effectiveness of digital adherence technologies on treatment outcome and adherence among drug-susceptible tuberculosis patients in India |
| Study objectives | The primary objective is to evaluate the relative impact of two digital adherence management strategies - toll-free calling (99DLite) and smart pillboxes (medication event reminder-monitor [MERM]) - on TB treatment adherence and outcomes, as compared to refill monitoring. There are two sub-studies nested within this trial with the following objectives: 1. To assess the behavioral mechanisms through which each DAT strategy influences adherence and outcomes 2. To assess the relative programmatic costs and cost-effectiveness of each DAT strategy |
| Ethics approval(s) |
1. Approved 11/11/2024, Institutional Ethics Committee, Dayanand Medical College & Hospital (Civil Lines, Ludhiana, 141001, India; +91 (0)161 468 7501; ethics.dmch@gmail.com), ref: 2024-993 2. Approved 01/03/2022, Institutional Review Board, Indian School of Business (Gachibowli, Hyderabad, 500111, India; +91 (0)40 2300 7000; irbassist@isb.edu), ref: 2022-09 |
| Health condition(s) or problem(s) studied | Tuberculosis (TB) |
| Intervention | This is a three-arm non-blinded, parallel-grouped, patient randomised trial with individual-level randomisation and a 1:1:1 allocation ratio, stratified by HCW and facility type (public vs private). Participants are randomised to one of three adherence management strategies: (1) toll-free calling (99DLite), (2) smart pillboxes (MERM), or (3) control group refill monitoring. All participants receive counselling at treatment initiation. Free first-line fixed-dose combination (FDC) therapy treatment is supplied at the diagnosing facility, per prescribed refill frequency. Intervention arm 1 – 99DLite: Participants receive a medication container labelled with a toll-free number and are oriented to call daily to confirm dose intake. Missed calls for 3 consecutive days trigger a follow-up phone call; 7 consecutive days trigger a home visit. Intervention arm 2 – MERM: Participants receive an electronic pillbox with an audio-visual alarm set to their preferred dose time; opening the lid automatically logs the dose daily. A missed signal for 3 consecutive days triggers a follow-up call; 7 consecutive days triggers a home visit. Control arm – Refill Monitoring: Participants receive a toll-free number on their initial prescription and are oriented to call at time of prescription refill (expected monthly). A missed call within 3 days of the refill due date triggers a follow-up call; 7 days triggers a home visit. Follow-ups for all three arms include adherence counselling, personalised counselling on treatment challenges, and troubleshooting, if any. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 19/10/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 982 |
| Total final enrolment | 1081 |
| Key inclusion criteria | 1. Notified in the national TB platform, Nikshay, in participating study sites 2. Aged 18 years or older 3. Diagnosed with pulmonary tuberculosis 4. Microbiologically confirmed by a nucleic acid amplification test (NAAT) with rifampicin sensitivity 5. Initiated on free first-line treatment with fixed-dose combination (FDC) therapy 6. Plans to reside in the study district for the treatment duration period 7. Has daily access to a mobile phone (own or a family member's) |
| Key exclusion criteria | 1. Extrapulmonary tuberculosis without pulmonary involvement 2. Mycobacterium tuberculosis (MTB) not detected on NAAT, or diagnosed with rifampicin-resistant or multidrug-resistant tuberculosis (RR-TB/MDR-TB) at enrolment 3. More than 25 days into treatment at the time of enrolment 4. Plans to migrate to a different district during the treatment duration period 5. Was part of similar digital adherence technology (DAT) interventions in prior programs 6. Has a household member concurrently enrolled in a DAT intervention 7. Unable or unwilling to provide informed consent 8. Follow-up not feasible due to inaccessible locations (e.g., prisons) |
| Date of first enrolment | 02/07/2025 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- India
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon reasonable request |
Editorial Notes
13/08/2026: Study's existence confirmed by the Institutional Review Board, Indian School of Business.
