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

This feasibility assessment is to provide quantitative findings of an intervention integrating immunizations into maternity and newborn care across 15 health facilities in Cameroon.

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Other: Integration of vaccination services into delivery services

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:

1. Integrate birth dose immunizations into maternity and immediate newborn care services
2. Measure the change in proportion of newborn receiving birth doses BCG and OPV0 within 24 hours compared to baseline data
3. Measure the change in average age of babies receiving birth doses of BCG and OPV0
4. 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cameroon
  • Adamawa
    • Dibi, Adamawa, Cameroon
      • CMA Dibi
  • Adamawe
    • Mbe, Adamawe, Cameroon
      • CMA Mbe
  • Center
    • Biyem Assi, Center, Cameroon
      • HD Biyem-Assi
    • Cite Verte, Center, Cameroon
      • HD Cite Verte
    • Djoungolo, Center, Cameroon
      • CMMR Etoudi
    • Efoulan, Center, Cameroon
      • CMA Ahala
    • Mbalmayo, Center, Cameroon
      • CSIU Mbalmayo II
    • Mfou, Center, Cameroon
      • CSC Nkoabang
    • Nkolndongo, Center, Cameroon
      • Hospital Nicolas Barre
    • Obala, Center, Cameroon
      • HD Obala
  • West
    • Baham, West, Cameroon
      • CSC Baham
    • Foumbot, West, Cameroon
      • HD Foumbot
    • Mifi, West, Cameroon
      • HD Mifi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Facilities will be those that have both an immunization unit as well as a maternity ward

Exclusion Criteria:

• Facilities without both units

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinton Health Access Initiative Inc.
• Collaborators: Bill and Melinda Gates Foundation; Cameroon Expanded Program on Immunization
• Investigators: Principal Investigator: Ankouane Andoulo Firmin, Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): December 11, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Hepatitis B
• Other Study ID Numbers: 2020/09/1695/L/CNERSH/SP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No