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

The Aurum Institute NPC

Status: Not yet enrolling

Conditions: TB - Tuberculosis; HIV; Children, Only; Household Contact

Study type: Observational

Funder types: Other

Identifiers

NCT06511180

AUR2-7-428

ERC.0004119 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,200 participants in 6 patient groups

Children <12 years who are eligible for TPT - HHC

Description:

No intervention. Clinic record review: Data will be retrospectively abstracted from routine medical files using a standardised data collection tool that will document TPT uptake and outcomes

Policy makers/Program managers

Description:

No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations.

Healthcare Workers

Description:

No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations.

Caregivers

Description:

No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations.

Pharmacy managers/pharmacists

Description:

No intervention. Clinic assessment: We will assess provider barriers and facilitators to prescribing the new dispersible 3HP (single dispersible formulations of isoniazid and rifapentine) through a survey tool which will collect information on the flow of TPT from national supply to the clinic and dispensing to the child.

Procurement managers/Supply managers

Description:

No intervention. Clinic assessment: We will assess provider barriers and facilitators to prescribing the new dispersible 3HP (single dispersible formulations of isoniazid and rifapentine) through a survey tool which will collect information on the flow of TPT from national supply to the clinic and dispensing to the child.