NCT03881228

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

Completed NA Last updated 15 April 2024

What this trial tests

NA trial testing Increasing the completion of IPT in Tuberculosis in 356 participants. Completed in 15 August 2023.

Timeline

1 December 2019

Primary endpoint
15 August 2023

15 August 2023

Quick facts

Lead sponsor	Universidad Peruana Cayetano Heredia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	356
Start date	1 December 2019
Primary completion	15 August 2023
Estimated completion	15 August 2023
Sites	1 location across Peru

Drugs / interventions tested

• Increasing the completion of IPT

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →
• Pediatric ALL — all drugs for Pediatric ALL →
• Behavior, Health — all drugs for Behavior, Health →

Sponsor

Universidad Peruana Cayetano Heredia — full company profile →

Who can join

Adults 1 Day to 100, any sex, with Tuberculosis or Pediatric ALL. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Otero L, Zetola N, Campos M, Zunt J, et al · · 2023 · cited 2× · PMID 36694242 · DOI 10.1186/s13063-022-07062-6