Cameroon HepB Birth Dose Feasibility Pilot
Primary Purpose
Hepatitis B
Status
Completed
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
Integration of vaccination services into delivery services
Sponsored by
About this trial
This is an interventional health services research trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria:
- Facilities will be those that have both an immunization unit as well as a maternity ward
Exclusion Criteria:
- Facilities without both units
Sites / Locations
- CMA Dibi
- CMA Mbe
- HD Biyem-Assi
- HD Cite Verte
- CMMR Etoudi
- CMA Ahala
- CSIU Mbalmayo II
- CSC Nkoabang
- Hospital Nicolas Barre
- HD Obala
- CSC Baham
- HD Foumbot
- HD Mifi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Arm
Arm Description
These facilities will be those selected to have the intervention carried out.
Outcomes
Primary Outcome Measures
Timeliness of birth dose vaccine administration
Median hours between birth and administration of oral polio and/or the BCG vaccine
Secondary Outcome Measures
Coverage of birth dose vaccines
The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine
Full Information
NCT ID
NCT04893616
First Posted
March 17, 2021
Last Updated
July 22, 2022
Sponsor
Clinton Health Access Initiative Inc.
Collaborators
Cameroon Expanded Program on Immunization, Bill and Melinda Gates Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04893616
Brief Title
Cameroon HepB Birth Dose Feasibility Pilot
Official Title
Improving Timeliness of Birth Dose Vaccines in 15 Health Facilities in Cameroon Through Integrating Immunizations Into Maternity and Newborn Care Services: A Feasibility Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
December 11, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinton Health Access Initiative Inc.
Collaborators
Cameroon Expanded Program on Immunization, Bill and Melinda Gates Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
These facilities will be those selected to have the intervention carried out.
Intervention Type
Other
Intervention Name(s)
Integration of vaccination services into delivery services
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timeliness of birth dose vaccine administration
Description
Median hours between birth and administration of oral polio and/or the BCG vaccine
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Coverage of birth dose vaccines
Description
The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine
Time Frame
20 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Facilities will be those that have both an immunization unit as well as a maternity ward
Exclusion Criteria:
Facilities without both units
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ankouane Andoulo Firmin
Organizational Affiliation
Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMA Dibi
City
Dibi
State/Province
Adamawa
Country
Cameroon
Facility Name
CMA Mbe
City
Mbe
State/Province
Adamawe
Country
Cameroon
Facility Name
HD Biyem-Assi
City
Biyem Assi
State/Province
Center
Country
Cameroon
Facility Name
HD Cite Verte
City
Cite Verte
State/Province
Center
Country
Cameroon
Facility Name
CMMR Etoudi
City
Djoungolo
State/Province
Center
Country
Cameroon
Facility Name
CMA Ahala
City
Efoulan
State/Province
Center
Country
Cameroon
Facility Name
CSIU Mbalmayo II
City
Mbalmayo
State/Province
Center
Country
Cameroon
Facility Name
CSC Nkoabang
City
Mfou
State/Province
Center
Country
Cameroon
Facility Name
Hospital Nicolas Barre
City
Nkolndongo
State/Province
Center
Country
Cameroon
Facility Name
HD Obala
City
Obala
State/Province
Center
Country
Cameroon
Facility Name
CSC Baham
City
Baham
State/Province
West
Country
Cameroon
Facility Name
HD Foumbot
City
Foumbot
State/Province
West
Country
Cameroon
Facility Name
HD Mifi
City
Mifi
State/Province
West
Country
Cameroon
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Cameroon HepB Birth Dose Feasibility Pilot
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