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

NCT06511180 | Not Yet Recruiting

• 2 other identifiers: AUR2-7-428ERC.0004119
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Overarching Objective

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

  18 months

• Primary Objective 1

  To quantify the TPT care cascade from identification, screening, eligibility, treatment initiation to completion among children \<12 years of age, stratified by regimen.

  18 months

Secondary Outcomes (4)

• Secondary Objective 1

  18 months

• Secondary Objective 2

  18 months

• Secondary Objective 3

  18 months

• Secondary Objective 4

  18 months

Other Outcomes (5)

• Outcome 1

  18 months

• Outcome 2

  18 months

• Outcome 3

  18 months

Study Arms (6)

Children <12 years who are eligible for TPT - HHC

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

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

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

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

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

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• The Aurum Institute NPC: lead
• Johns Hopkins University: collaborator
• KNCV Tuberculosis Foundation: collaborator
• Clinton Health Access Initiative Inc.: collaborator

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Central Study Contacts

Violet Chihota

CONTACT

+27 (0) 82 319 1559; vchihota@auruminstitute.org

Rachel Mukora

CONTACT

+27 (0) 83 784 3107; rmukora@auruminstitute.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 19, 2024
• Study Start: August 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07