Clinical trial · Interventional
Patient Centered Intervention to Prevent Tuberculosis Among Children Under Five Years Old
Patient Centered Intervention to Prevent Tuberculosis Among Children Under Five Years Old Who Are Household Contacts of Persons With Tuberculosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Isoniazid preventive therapy (IPT) reduces the risk of tuberculosis in 60%. Young children are at higher risk of developing severe forms of TB, though this can be prevented with a full course of IPT. Preliminary data indicate that 60% of eligible children start IPT, and 30% complete it. Furthermore, children can be exposed to more than one case of TB in the household. Adults exposed to TB in the household setting are not necessarily aware of their risk. Uncertainties in the decisions of staff to prescribe IPT and limited health literacy among caretakers and families contribute to this. The investigators will determine the efficacy of an intervention package to increase IPT adherence and completion among children \< 5 years old exposed to TB in the household. The investigators will assess the efficacy of the intervention by 1) measuring IPT completion at 6 months after treatment initiation and by 2) determining adherence to IPT by measuring isoniazid in urine at weeks 2, 8 and 24 in a random cluster sample of 10 health facilities and 20 control facilities with 10 children included in each facility (100 in intervention and 200 in control). The investigators will measure fidelity and reach, and acceptability among caretakers and health staff. The intervention package will consist of: 1) educational booklet for caretakers explaining why IPT needs to be given 2) a children's storybook, with weekly installments, over the 6-month course of IPT as a non-monetary incentive and 3) short messages services (SMS) reminders delivered to the caretaker for the weekly pick-up In September 2020, the protocol was updated to adapt to the COVID19 situation in Lima. One of the secondary outcome (isoniazid concentration in urine) was cancelled and the full intervention (educational booklet, weekly children storybook and weekly SMS) is now delivered through WhatsApp.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Behavior, Health | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Tuberculosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Increasing the completion of IPT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 1. at enrollment, caretakers will receive an educational booklet for caretakers explaining why IPT needs to be given 2. at enrollment and weekly for 24 weeks, caretakers will receive a children's storybook, with weekly installments, over the 6-month course of IPT as a non-monetary incentive 3. weekly, caretakers will receive short messages services (SMS) reminders delivered to the caretaker for the weekly pick-up.
- interventionNames
- Behavioral: Increasing the completion of IPT
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- Routine care at the health facility
Primary outcomes (1)
- measure
- Isoniazid preventive treatment completion at week 24 recorded in treatment card
- timeFrame
- 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Caretakers of a child who is 1) \< 5 years old 2) contact of a TB patient 3) has an IPT prescription from the TB physician and 4) has a smartphone that can use WhatsApp to receive the intervention. Exclusion Criteria: * Caretaker does not want to participate or cannot provide consent
References
Publications (1)
- DERIVEDOtero L, Zetola N, Campos M, Zunt J, Bayer A, Curisinche M, Ochoa T, Reyes M, Vega V, Van der Stuyft P, Sterling TR. Isoniazid preventive therapy completion in children under 5 years old who are contacts of tuberculosis cases in Lima, Peru: study protocol for an open-label, cluster-randomized superiority trial. Trials. 2023 Jan 24;24(1):54. doi: 10.1186/s13063-022-07062-6. PMID 36694242