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