An interventional study of Integration of vaccination services into delivery services in Hepatitis B, sponsored by Clinton Health Access Initiative Inc.. Completed at 13 sites in Cameroon. Per ClinicalTrials.gov, last updated 2022-07-25.
Sponsored by Clinton Health Access Initiative Inc. · Not applicable, Interventional, and Health services research
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.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's enrollment of 13 is below the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Clinton Health Access Initiative Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
These facilities will be those selected to have the intervention carried out.
Other: Integration of vaccination services into delivery services
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.
Timeliness of birth dose vaccine administration
Median hours between birth and administration of oral polio and/or the BCG vaccine
Time frame: 20 weeks
Coverage of birth dose vaccines
The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine
Time frame: 20 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Clinton Health Access Initiative Inc.