Children, Only, HIV, Household Contact, TB - Tuberculosis
Conditions
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.
Interventions
None listed
Sponsors
Johns Hopkins University
KNCV Tuberculosis Foundation
Clinton Health Access Initiative Inc.
The Aurum Institute NPC
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overarching Objective | 18 months | 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. |
| Primary Objective 1 | 18 months | To quantify the TPT care cascade from identification, screening, eligibility, treatment initiation to completion among children \<12 years of age, stratified by regimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Objective 1 | 18 months | To quantify the prescription of the new dispersible 3HP vs other regimens among children \<12 years. |
| Secondary Objective 2 | 18 months | To explore policy makers, healthcare workers and caregivers' insights on different regimens and formulations. |
| Secondary Objective 3 | 18 months | To assess provider-level barriers and facilitators to delivery of the new dispersible 3HP regimen. |
| Secondary Objective 4 | 18 months | To determine the impact of the new dispersible 3HP on supply chain and changes needed to accommodate them. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Outcome 2 | 18 months | Proportion of children \<12 years initiated on TPT who complete treatment, stratified by regimen. |
| Outcome 3 | 18 months | Caregiver experience with and attitudes towards the new dispersible 3HP formulation. |
| Outcome 4 | 18 months | Barriers and facilitators of the new dispersible 3HP experienced by healthcare workers and policy makers. |
| Outcome 5 | 18 months | Logistics and supply chain issues related to country level procurement, forecasting and distribution to clinic level for the dispersible 3HP. |
| Outcome 1 | 18 months | Any uptake of TPT defined as proportion of eligible children who are initiated on TPT, stratified by regimen |
Contacts
Primary ContactViolet Chihota
Backup ContactRachel Mukora
Outcome results
None listed