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Integrating pediatric TB services into child healthcare services in Africa: study protocol for the INPUT
Lise Denoeud-Ndam1, Rose Otieno-Masaba2, Boris Tchounga3
1EGPAF, Geneva, Switzerland. ldenoeud@pedaids.org.
Insights
Integrating tuberculosis (TB) services into child healthcare improves diagnosis in young children. This study assessed the effectiveness of this integrated approach for pediatric TB diagnosis in Cameroon and Kenya.
Area of Science:
- Pediatric infectious diseases
- Public health interventions
- Global health
Background:
- Tuberculosis (TB) is a leading cause of mortality in children globally, with over 1 million cases annually.
- Accurate diagnosis of active TB in young children presents significant challenges.
- The INPUT study addresses these challenges by evaluating integrated TB services.
Purpose of the Study:
- To assess the effectiveness of integrating TB services into routine child healthcare.
- To improve TB diagnosis capacities in children under 5 years of age.
- To evaluate the impact on TB screening, diagnosis, and treatment initiation.
Main Methods:
- A stepped-wedge cluster-randomized trial in 12 clusters across Cameroon and Kenya.
- Comparison of standard TB care versus integrated TB services (training, supervision, job aids, logistics).
- Enrollment of children under 5 with presumptive TB; prospective data abstraction from medical records.
Main Results:
- Primary outcome: proportion of TB cases diagnosed in children under 5 attending child healthcare services.
- Secondary outcomes: number screened, diagnosed, initiated on treatment, and completing treatment.
- Evaluation of cost-effectiveness, acceptability, and implementation fidelity.
Conclusions:
- Study enrollment and follow-up are ongoing, with findings expected by mid-2021.
- Results will inform innovative approaches for integrating TB services into child healthcare.
- Dissemination to national, regional, and international audiences is planned.
Background:
Tuberculosis is among the top-10 causes of mortality in children with more than 1 million children suffering from TB disease annually worldwide. The main challenge in young children is the difficulty in establishing an accurate diagnosis of active TB. The INPUT study is a stepped-wedge cluster-randomized intervention study aiming to assess the effectiveness of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age.
Methods:
Two strategies will be compared: i) The standard of care, offering pediatric TB services based on national standard of care; ii) The intervention, with pediatric TB services integrated into child healthcare services: it consists of a package of training, supportive supervision, job aids, and logistical support to the integration of TB screening and diagnosis activities into pediatric services. The design is a cluster-randomized stepped-wedge of 12 study clusters in Cameroon and Kenya. The sites start enrolling participants under standard-of-care and will transition to the intervention at randomly assigned time points. We enroll children aged less than 5 years with a presumptive diagnosis of TB after obtaining caregiver written informed consent. The participants are followed through TB diagnosis and treatment, with clinical information prospectively abstracted from their medical records. The primary outcome is the proportion of TB cases diagnosed among children < 5 years old attending the child healthcare services. Secondary outcomes include: number of children screened for presumptive active TB; diagnosed; initiated on TB treatment; and completing treatment. We will also assess the cost-effectiveness of the intervention, its acceptability among health care providers and users, and fidelity of implementation.
Discussion:
Study enrolments started in May 2019, enrolments will be completed in October 2020 and follow up will be completed by June 2021. The study findings will be disseminated to national, regional and international audiences and will inform innovative approaches to integration of TB screening, diagnosis, and treatment initiation into child health care services.
Trial Resistration:
NCT03862261, initial release 12 February 2019.
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