Patient Centered Intervention to Prevent Tuberculosis Among Children Under Five Years Old
Primary Purpose
Tuberculosis, Pediatric ALL, Behavior, Health
Status
Recruiting
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Increasing the completion of IPT
Sponsored by
About this trial
This is an interventional prevention trial for Tuberculosis
Eligibility Criteria
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
Sites / Locations
- Instituto de Medicina Tropical Alexander von HumboldtRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Standard of care
Arm Description
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.
Routine care at the health facility
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT03881228
First Posted
March 14, 2019
Last Updated
May 19, 2022
Sponsor
Universidad Peruana Cayetano Heredia
1. Study Identification
Unique Protocol Identification Number
NCT03881228
Brief Title
Patient Centered Intervention to Prevent Tuberculosis Among Children Under Five Years Old
Official Title
Patient Centered Intervention to Prevent Tuberculosis Among Children Under Five Years Old Who Are Household Contacts of Persons With Tuberculosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Peruana Cayetano Heredia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pediatric ALL, Behavior, Health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Routine care at the health facility
Intervention Type
Behavioral
Intervention Name(s)
Increasing the completion of IPT
Intervention Description
Behavioral intervention with three components to increase the completion of IPT among children
Primary Outcome Measure Information:
Title
Isoniazid preventive treatment completion at week 24 recorded in treatment card
Description
Completion of 24 weeks of IPT as per weekly pick ups registered in TB forms
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Isoniazid preventive treatment completion at week 20 recorded in treatment card
Description
Completion of 20 weeks of IPT as per weekly pick ups registered in TB forms
Time Frame
20 weeks
Title
Questionnaire on self reported adherence to daily treatment
Description
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
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Larissa Otero, MD PhD
Phone
513190000
Email
larissa.otero@upch.pe
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa Otero, MD PhD
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Medicina Tropical Alexander von Humboldt
City
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larissa Otero, PhD
Phone
513190000
Email
larissa.otero@upch.pe
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Patient Centered Intervention to Prevent Tuberculosis Among Children Under Five Years Old
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