Clinical trial NCT06511180: Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation
Official title: Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: TB - Tuberculosis
Household Contact
HIV
Children, Only
Lead sponsor: The Aurum Institute NPC
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: KNCV Tuberculosis Foundation
name: Clinton Health Access Initiative Inc.
First posted: 2024-07-19
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic record review: Routine program data for CLHIV \<12 years or children \<12 years who are household contacts of people living with TB, who are initiated on TPT.

\[A household contact is defined as a person who shared the same enclosed living space with the index patient (someone with infectious TB as defined by country guidelines) for one or more nights or for frequent or extended periods during the day during the 3 months before commencement of the current treatment episode.\]

Qualitative study: Policy makers, healthcare workers and parents/caregivers will be interviewed - (\>18 years)

Clinic-level assessment: Pharmacy managers/pharmacists, procurement and supply management staff - (\>18 years)

Brief summary: The WHO has recommended TB preventive therapy (TPT) for children living with HIV (CLHIV) and household contacts of people living with TB, however, the scale-up and implementation of TPT has been sub-optimal globally particularly in children. A safe and effective short-course TPT regimen, 3HP (rifapentine and isoniazid given once weekly for three months), is available but there is a lack of child-friendly formulations resulting in increased pill burden and there is a need to improve acceptability and adherence among children. The introduction of a dispersible rifapentine formulation has potential to improve uptake, treatment adherence and completion.

Overall goal is to generate critical knowledge to improve delivery of TPT and, more specifically, of dispersible 3HP, in children in routine programs.

This evaluation will create an important understanding of TPT uptake and completion among children and assess the impact of the introduction of a dispersible 3HP formulation. These results will provide actionable information for improving service delivery and the scale-up of TPT in the respective countries.


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.

Primary outcomes:
measure: Overarching Objective
timeFrame: 18 months
measure: Primary Objective 1
timeFrame: 18 months
Secondary outcomes:
measure: Secondary Objective 1
timeFrame: 18 months
measure: Secondary Objective 2
timeFrame: 18 months
measure: Secondary Objective 3
timeFrame: 18 months
measure: Secondary Objective 4
timeFrame: 18 months
Other outcomes:
measure: Outcome 1
timeFrame: 18 months
measure: Outcome 2
timeFrame: 18 months
measure: Outcome 3
timeFrame: 18 months
measure: Outcome 4
timeFrame: 18 months
measure: Outcome 5
timeFrame: 18 months
Locations:
Study officials:
References: