Patient Centered Intervention to Prevent Tuberculosis Among Children Under Five Years Old

NCT03881228 | Completed

• 1 other identifier: 103161
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

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

Tuberculosis; Pediatric ALL; Behavior, Health

Outcome Measures

Primary Outcomes (1)

• Isoniazid preventive treatment completion at week 24 recorded in treatment card

  Completion of 24 weeks of IPT as per weekly pick ups registered in TB forms

  24 weeks

Secondary Outcomes (2)

• Isoniazid preventive treatment completion at week 20 recorded in treatment card

  20 weeks

• Questionnaire on self reported adherence to daily treatment

  24 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Increasing the completion of IPT

Standard of care

NO INTERVENTION

Routine care at the health facility

Interventions

Increasing the completion of IPT BEHAVIORAL

Behavioral intervention with three components to increase the completion of IPT among children

Intervention

Eligibility Criteria

• Age: 1 Day - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Caretaker does not want to participate or cannot provide consent

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead

Study Sites (1)

Instituto de Medicina Tropical Alexander von Humboldt

Lima, Peru

Location

Related Publications (1)

• Otero 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 DERIVED

MeSH Terms

Conditions

Tuberculosis; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Health Behavior

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Study Officials

• Larissa Otero, MD PhD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 19, 2019
• Study Start: December 1, 2019
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: April 15, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Upon completion of the study, for five years.
• Access Criteria: Individual patient data will be submitted by the PI (Larissa Otero) upon request by other researchers.

Locations

PE (1)