Cameroon HepB Birth Dose Feasibility Pilot
Improving Timeliness of Birth Dose Vaccines in 15 Health Facilities in Cameroon Through Integrating Immunizations Into Maternity and Newborn Care Services: A Feasibility Assessment
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In the Cameroon Expanded Program on Immunization (EPI), the birth dose vaccine for oral polio vaccine (OPV-0) and tuberculosis vaccine (BCG), are recommended with a third birth dose vaccine for hepatitis B (HepB-BD) being considered for introduction.
Although Cameroon introduced the HepB antigen as part of the Pentavalent vaccine into the immunization program in 2005, infants are currently unprotected until the first Penta shot at six weeks. Introduction of HepB-BD is a key priority for the Cameroon government through the National Cancer Strategy document as well as the Hepatitis Prevention and Treatment Guidelines. However, the timeliness of administration of Hepatitis B vaccine within 24 hours of birth is critical to ensure the highest efficacy and prevent transmission of the virus.
While coverage rates for BCG and OPV 0 are relatively high (91% and 78% respectively), these vaccines are often administered weeks or months after birth , not within the 24-hour timeframe recommended for Hepatitis B birth dose. Therefore, there are concerns from the Cameroon National Immunization Technical Advisory Group (NITAG) and other stakeholders on the feasibility of achieving high timely coverage of HepB-BD. The timeliness of administration of the birth dose vaccines within facilities relies on many system components including integrated processes between maternity and immunization units and healthcare worker awareness of birth dose administration guidelines.
The main aim of this pilot study is to assess the feasibility of immunizing newborns with BCG and OPV0 (and eventually HepB-BD) within 24 hours of birth by integrating routine immunization into maternity and immediate newborn care in 15 facilities in Cameroon.
Further, the specific objectives of this pilot study are to:
- Integrate birth dose immunizations into maternity and immediate newborn care services
- Measure the change in proportion of newborn receiving birth doses BCG and OPV0 within 24 hours compared to baseline data
- Measure the change in average age of babies receiving birth doses of BCG and OPV0
- Assess the operational feasibility and acceptability of interventions and describe any factors (barriers and enablers) that may influence further implementation of birth dose strategies
This feasibility assessment is to provide quantitative findings of an intervention integrating immunizations into maternity and newborn care across 15 health facilities in Cameroon. Overall, in 20 weeks an intervention phase will be followed by a final assessment. The approach will utilize quantitative data from healthcare worker surveys, the birth registry and immunization registry, and maternity unit reporting forms. The study findings will be used to inform strategy on HepB-BD introduction in Cameroon as well as interventions to strengthen service delivery structures for newborns.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Adamawa
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Dibi, Adamawa, Camerún
- CMA Dibi
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Adamawe
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Mbe, Adamawe, Camerún
- CMA Mbe
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Center
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Biyem Assi, Center, Camerún
- HD Biyem-Assi
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Cite Verte, Center, Camerún
- HD Cite Verte
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Djoungolo, Center, Camerún
- CMMR Etoudi
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Efoulan, Center, Camerún
- CMA Ahala
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Mbalmayo, Center, Camerún
- CSIU Mbalmayo II
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Mfou, Center, Camerún
- CSC Nkoabang
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Nkolndongo, Center, Camerún
- Hospital Nicolas Barre
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Obala, Center, Camerún
- HD Obala
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West
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Baham, West, Camerún
- CSC Baham
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Foumbot, West, Camerún
- HD Foumbot
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Mifi, West, Camerún
- HD Mifi
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Facilities will be those that have both an immunization unit as well as a maternity ward
Exclusion Criteria:
- Facilities without both units
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention Arm
These facilities will be those selected to have the intervention carried out.
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The purpose of the work is to integrate readily available birth dose vaccinations (Oral Polio and the Tuberculosis vaccine) currently given in a separate clinic into the maternity delivery services through improved training, checklist, and job aides.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Timeliness of birth dose vaccine administration
Periodo de tiempo: 20 weeks
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Median hours between birth and administration of oral polio and/or the BCG vaccine
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20 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Coverage of birth dose vaccines
Periodo de tiempo: 20 weeks
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The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine
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20 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ankouane Andoulo Firmin, Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2020/09/1695/L/CNERSH/SP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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