MedTrace Logo

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

NCT03881228 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2024-04-15

No results posted yet for this study

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

Interventions

BEHAVIORAL

Increasing the completion of IPT

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

Sponsors & Collaborators

  • Universidad Peruana Cayetano Heredia

    lead OTHER

Principal Investigators

  • Larissa Otero, MD PhD · Universidad Peruana Cayetano Heredia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2023-08-15
Completion
2023-08-15

Countries

  • Peru

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03881228 on ClinicalTrials.gov