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| Name | Class |
|---|---|
| Cameroon Expanded Program on Immunization | UNKNOWN |
| Bill and Melinda Gates Foundation | OTHER |
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This feasibility assessment is to provide quantitative findings of an intervention integrating immunizations into maternity and newborn care across 15 health facilities in Cameroon.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | These facilities will be those selected to have the intervention carried out. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integration of vaccination services into delivery services | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Timeliness of birth dose vaccine administration | Median hours between birth and administration of oral polio and/or the BCG vaccine | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Coverage of birth dose vaccines | The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine | 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ankouane Andoulo Firmin | Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMA Dibi | Dibi | Adamaoua Region | Cameroon | |||
| CMA Mbe |
Data on individual participant data will not be shared with other researchers. All reports will have data aggregated to the facility level. No personal identifiers will be gathered.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 27, 2021 | May 17, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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|
| Mbé |
| Adamawe |
| Cameroon |
| HD Biyem-Assi | Biyem Assi | Center | Cameroon |
| HD Cite Verte | Cite Verte | Center | Cameroon |
| CMMR Etoudi | Djoungolo | Center | Cameroon |
| CMA Ahala | Efoulan | Center | Cameroon |
| CSIU Mbalmayo II | Mbalmayo | Center | Cameroon |
| CSC Nkoabang | Mfou | Center | Cameroon |
| Hospital Nicolas Barre | Nkolndongo | Center | Cameroon |
| HD Obala | Obala | Center | Cameroon |
| CSC Baham | Baham | West Region | Cameroon |
| HD Foumbot | Foumbot | West Region | Cameroon |
| HD Mifi | Mifi | West Region | Cameroon |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |