Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation

Launched by THE AURUM INSTITUTE NPC · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help prevent tuberculosis (TB) in children who live with HIV or are in close contact with someone who has TB. The study focuses on a treatment called 3HP, which consists of two medications taken once a week for three months. Currently, there are challenges in getting children to take this treatment because the pills are not designed for kids, making it hard for them to swallow. By introducing a new, dispersible form of the medication that can be mixed with water, the researchers hope to make it easier for children to take their medicine, which could improve the number of children who complete the treatment.

To participate in the study, children under 12 years old must be either living with HIV or have been in close contact with someone who has TB. Caregivers of these children, healthcare workers involved in treating pediatric patients, and policymakers managing TB programs are also included in the study. Participants will share their experiences and feedback, helping researchers understand how to better deliver this preventive treatment. The findings will help improve how TB prevention is provided to children across various countries.

Gender

ALL

Eligibility criteria

• • Clinic record review
• Inclusion Criteria:
• • Medical records of children \<12 years who are either CLHIV or who are household contacts of people with pulmonary TB and who are initiated on TPT
• Exclusion Criteria:
• • Records will be excluded for children who are contacts of a drug-resistant, have presumptive TB disease or are currently on TB treatment
• • Qualitative study
• Inclusion Criteria:
• • Adult caregiver (\>18 years) of a child \<12 years of age who is eligible for TPT
• • Healthcare worker from one of the clinics in which the study will be conducted who sees outpatient pediatric consultations including TB-exposed children
• • Policy maker or program manager who manages or is involved in PMTCT, TB and/or pediatric programming
• Exclusion Criteria:
• • Any adult caregivers, healthcare workers, policy makers or program managers who are unable or unwilling to provide informed consent for both the interview and audio-recording.