Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 主要终点
- Overarching Objective
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Overarching Objective
时间窗: 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
时间窗: 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.
次要结局
- Secondary Objective 3(18 months)
- Secondary Objective 2(18 months)
- Secondary Objective 1(18 months)
- Secondary Objective 4(18 months)