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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis; Pediatric ALL; Behavior, Health
• Intervention / Treatment: Behavioral: Increasing the completion of IPT

Detailed Description

A cluster randomized study was designed, randomizing 10 health facilities to the intervention arm and 20 to control arm. In each, 10 children will be recruited. The mother, or the main caretaker in the intervention arm will receive the intervention package: 1) an educational booklet indicating the importance of IPT, adherence to IPT as well as information on how to give it daily for six months. Thereafter, the mother or main caretaker receives 2) a chapter of a children storybook delivered weekly and 3) SMS to remind her of the pick up, as well as weekly SMS containing a motivating message. Until March 2020, component 1 and 2 of the intervention package were delivered in person, since September 2020 and in adaptation to the SARS Cov2 pandemic, these are delivered via WhatsApp. Children in the control arm will receive the standard of care which consists of a advice and counseling given by the doctor and nurse at the health facility.

The investigators will assess the efficacy of the intervention by 1) measuring IPT completion at 6 months after treatment initiation. The secondary outcome originally planned (determining adherence to IPT by measuring isoniazid in urine at weeks 2, 8 and 24) has been cancelled in adaptation to the SARS Cov2 pandemic.

Fidelity, reach and acceptability will be measured among caretakers and staff with an in depth interview at the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 356
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larissa Otero, MD PhD; Phone Number: 513190000; Email: larissa.otero@upch.pe

Study Locations

• Peru
  • Lima, Peru
    • Instituto de Medicina Tropical Alexander von Humboldt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; at enrollment, caretakers will receive an educational booklet for caretakers explaining why IPT needs to be given; 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; weekly, caretakers will receive short messages services (SMS) reminders delivered to the caretaker for the weekly pick-up.	Behavioral: Increasing the completion of IPT; Behavioral intervention with three components to increase the completion of IPT among children
No Intervention: Standard of care; Routine care at the health facility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isoniazid preventive treatment completion at week 20 recorded in treatment card	Completion of 20 weeks of IPT as per weekly pick ups registered in TB forms	20 weeks
Questionnaire on self reported adherence to daily treatment	Self report of providing daily dose IPT to the child at home as reported by the caretaker to the question: did you give the daily dose to the child? possible answers are yes/no	24 weeks

Collaborators and Investigators

• Sponsor: Universidad Peruana Cayetano Heredia
• Investigators: Principal Investigator: Larissa Otero, MD PhD, Universidad Peruana Cayetano Heredia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 103161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All study data can be shared with other researcher for research purposes as allowed in the IRB application.
• IPD Sharing Time Frame: Upon completion of the study, for five years.
• IPD Sharing Access Criteria: Individual patient data will be submitted by the PI (Larissa Otero) upon request by other researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No