This evaluation will be conducted in ten countries involved in the Catalyzing Pediatric TB Innovation (CaP-TB) project: Cameroon, Cote D'Ivoire, Democratic Republic of Congo, Kenya, Lesotho, Malawi, Tanzania, Uganda, Zimbabwe and India. The CaP-TB project is a project designed to use innovative methods and capacity building to strengthen the health systems of developing countries in terms of pediatric TB case detection, early accurate diagnosis and effective treatment. This project is funded by Unitaid and is implemented by Elizabeth Glaser Pediatric AIDS Foundation. EGPAF proposes to evaluate the implementation of CaP-TB in up to 450 sites in ten participating countries. This evaluation will assess the effects of CaP-TB innovative interventions on selected service delivery outcomes as compared to routine TB program in a sub-set of project sites in the ten countries.
This pre-post quasi-experimental evaluation study will be conducted in ten countries involved in the Catalyzing Pediatric TB Innovation (CaP-TB) project: Cameroon, Cote D'Ivoire, Democratic Republic of Congo, Kenya, Lesotho, Malawi, Tanzania, Uganda, Zimbabwe and India. The CaP-TB project is a project designed to use innovative methods and capacity building to strengthen the health systems of developing countries in terms of pediatric TB case detection, early accurate diagnosis and effective treatment. This project is funded by Unitaid headquartered in Geneva, Switzerland and is implemented by Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) with headquarters in Washington, D.C. and Geneva and 10 country offices. This study will assess the effects of CaP-TB innovative interventions on selected service delivery outcomes as compared to routine TB program in a sub-set of project sites in ten countries. The CaP TB project is a 4-year (October 1, 2017-September 30, 2021) Unitaid-funded project to improve pediatric TB outcomes by introducing integrated and decentralized models of pediatric TB care and strengthening access to WHO-recommended drugs and diagnostics. Integration refers to supporting TB activities, such as screening and TB sample collection for children, into non-TB health care services, such as general pediatric outpatient clinics. Decentralization refers to moving pediatric TB services from higher levels of health clinics to lower levels. Objectives of the study To evaluate the CaP TB project on the below TB service indicators and clinical outcomes for children 0-14 in facilities implementing the CaP TB project: * Number and proportion of children screened for TB among clinic attendees * Number and proportion of presumptive TB cases referred for lab-based TB diagnosis * Number and proportion of pediatric presumptive TB cases who are tested with Xpert * Number and proportion (out of all children screened) of pediatric cases diagnosed with active TB disease * Time between when a child is identified as a presumptive TB case and when the child is diagnosed with TB * Number and proportion of pediatric TB cases started on DS-TB treatment * Time between when a child is identified as a presumptive TB case and when the child is initiated on TB treatment * Number and proportion of pediatric DS-TB cases or cases treated with first-line TB treatment who achieve treatment success * Number and proportion of all TB index cases for whom successful contact tracing has been done * Number and proportion of pediatric household contacts who are negative to TB screening Study data Pre-intervention retrospective data collection Under the standard of care condition (baseline), the investigators will: * Capture data that will answer the TB service indicators and clinical outcomes listed in the primary objectives. * Capture key data points that will be needed to estimate project targets In each site, trained data collectors will retrospectively extract data from appropriate registers, logs, and in some cases patient files, for a period of 12 months starting 6 months before the start date of data extraction. After the implementation of the CaP TB project, prospective data will be collected by project-specific data collection tools and/or from existing registers. Whenever possible, the CaP TB data collection will use existing site level data collection tools to gather the data for the project.
Study Type
OBSERVATIONAL
Enrollment
4,159,533
Includes integration of TB care in non-TB entry points in facilities, decentralization from higher level clinics to lower levels, strengthening screening activities and building diagnosis and treatment capacity among healthcare workers
Sites in Centre, Littoral and West regions
Djoungolo, Cameroon
Adjame-Plateau-Attecoube, Abobo Est,Anyama , Koumassi-Port Bouet-Vridi, Treichville-Marcory
Abidjan, Côte d’Ivoire
Bandalungwa,Binza Meteo,Kikimi,Kingasani,Kinshasa, Lingwala, Masina II, Mont Ngafula II, Ndjili
Kinshasa, Democratic Republic of the Congo
Sites in Maharashtra State, Telangana State, Andhra Pradesh
Hyderabad, India
Turkana County and Homabay County sites
Nairobi, Kenya
Berea, Maseru, Mageteng, Leribe, Mohale's Hoek sites
Maseru, Lesotho
Central Region, Southern region sites
Dedza, Malawi
Singida, Tabora sites
Singida, Tanzania
Mbarara sites
Mbarara, Uganda
Harare, Manicaland, Matabeleland South
Harare, Zimbabwe
Children Screened for TB
Number and proportion of children (age 0-14) screened for TB among clinic attendees
Time frame: December 2018-September 2021
Children With Presumptive TB
Among those screened the number and proportion of children presumed to have TB.
Time frame: December 2018-September 2021
Children With Presumptive TB Referred for Lab-based TB Diagnosis
Number and proportion of presumptive TB cases referred for lab-based TB diagnosis
Time frame: December 2018-September 2021
Children With Presumptive TB Tested Using GeneXpert
Number and proportion of pediatric (0-14 years) presumptive TB cases who are tested with GeneXpert
Time frame: December 2018-September 2021
Children Initiated on TB Preventive Therapy
Number and proportion of pediatric patients started on preventive therapy of those who are eligible for preventive therapy
Time frame: December 2018-September 2021
Children Completing TB Preventive Therapy
Number and proportion of pediatric patients on preventive treatment who completed therapy
Time frame: December 2018-September 2021
Children Diagnosed With Active TB
Number of pediatric cases diagnosed with active TB disease among children with presumptive TB
Time frame: December 2018-September 2021
Children Initiated on TB Treatment
Number and proportion of pediatric TB cases started on DS-TB treatment
Time frame: December 2018-September 2021
Children Achieving Treatment Success
Number and proportion of pediatric DS-TB cases who achieve treatment success
Time frame: December 2018-September 2021
TB Contacts Successfully Traced
Number and proportion of all TB index cases for whom successful contact tracing has been done
Time frame: December 2018-September 2021
TB Contacts Screened Negative for TB
Number and proportion of pediatric household contacts who are negative to TB screening
Time frame: December 2018-September 2021
TB Contacts Eligible for Preventive Therapy
Number and proportion of screened negative pediatric contacts eligible for preventive therapy
Time frame: December 2018-September 2021
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