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

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ClinicalTrials.gov Identifier: NCT03881228
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

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 sample of 40 children (20 in each arm). 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

Condition or disease Intervention/treatment Phase
Tuberculosis Pediatric ALL Behavior, Health Behavioral: Increasing the completion of IPT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Patient Centered Intervention to Prevent Tuberculosis Among Children Under Five Years Old Who Are Household Contacts of Persons With Tuberculosis
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: Intervention
  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
Behavioral intervention with three components to increase the completion of IPT among children

No Intervention: Standard of care
Routine care at the health facility



Primary Outcome Measures :
  1. Isoniazid preventive treatment completion at week 24 recorded in treatment card [ Time Frame: 24 weeks ]
    Completion of 24 weeks of IPT as per weekly pick ups registered in TB forms


Secondary Outcome Measures :
  1. Isoniazid preventive treatment completion at week 20 recorded in treatment card [ Time Frame: 20 weeks ]
    Completion of 20 weeks of IPT as per weekly pick ups registered in TB forms

  2. Questionnaire on self reported adherence to daily treatment [ Time Frame: 24 weeks ]
    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

  3. Isoniazid concentration in biological specimens [ Time Frame: 24 weeks ]
    Isoniazid concentration in urine and hair



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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  • Caretaker does not want to participate or cannot provide consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881228


Locations
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Peru
Instituto de Medicina Tropical Alexander von Humboldt Not yet recruiting
Lima, Peru
Contact: Larissa Otero, PhD    51940709888    larissa.otero@upch.pe   
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia

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Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT03881228     History of Changes
Other Study ID Numbers: 103161
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All study data can be shared with other researcher for research purposes as allowed in the IRB application.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Upon completion of the study, for five years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections