Cameroon HepB Birth Dose Feasibility Pilot

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Timeliness of Birth Dose Vaccines in 15 Health Facilities in Cameroon Through Integrating Immunizations Into Maternity and Newborn Care Services: A Feasibility Assessment

Conditions
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Hepatitis B

Intervention / Treatment
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* Other: Integration of vaccination services into delivery services


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Facilities will be those that have both an immunization unit as well as a maternity ward Exclusion Criteria: Facilities without both units
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>These facilities will be those selected to have the intervention carried out. | Other: Integration of vaccination services into delivery services<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |