Cameroon HepB Birth Dose Feasibility Pilot

NCT ID: NCT04893616

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2021-12-31

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:

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.

Conditions

Hepatitis B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Arm

These facilities will be those selected to have the intervention carried out.

Group Type: EXPERIMENTAL

Integration of vaccination services into delivery services

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cameroon Expanded Program on Immunization

UNKNOWN

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Clinton Health Access Initiative Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ankouane Andoulo Firmin

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé

Locations

CMA Dibi

Dibi, Adamaoua Region, Cameroon

CMA Mbe

Mbé, Adamawe, Cameroon

HD Biyem-Assi

Biyem Assi, Center, Cameroon

HD Cite Verte

Cite Verte, Center, Cameroon

CMMR Etoudi

Djoungolo, Center, Cameroon

CMA Ahala

Efoulan, Center, Cameroon

CSIU Mbalmayo II

Mbalmayo, Center, Cameroon

CSC Nkoabang

Mfou, Center, Cameroon

Hospital Nicolas Barre

Nkolndongo, Center, Cameroon

HD Obala

Obala, Center, Cameroon

CSC Baham

Baham, West Region, Cameroon

HD Foumbot

Foumbot, West Region, Cameroon

HD Mifi

Mifi, West Region, Cameroon

Countries

Cameroon

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2020/09/1695/L/CNERSH/SP

Identifier Type: -

Identifier Source: org_study_id