Cameroon HepB Birth Dose Feasibility Pilot

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04893616
• Other study ID #: 2020/09/1695/L/CNERSH/SP
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Clinton Health Access Initiative Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 31, 2021
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Facilities without both units

Related Conditions & MeSH terms

• Hepatitis B

Intervention

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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Clinton Health Access Initiative Inc.	Bill and Melinda Gates Foundation, Cameroon Expanded Program on Immunization

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeliness of birth dose vaccine administration	Median hours between birth and administration of oral polio and/or the BCG vaccine	20 weeks
Secondary	Coverage of birth dose vaccines	The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine	20 weeks