Clinical trial NCT04893616: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Lead sponsor: Clinton Health Access Initiative Inc.
Sponsor class: OTHER
Collaborators: name: Cameroon Expanded Program on Immunization
name: Bill and Melinda Gates Foundation
First posted: 2021-05-19
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Timeliness of birth dose vaccine administration
timeFrame: 20 weeks
Secondary outcomes:
measure: Coverage of birth dose vaccines
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Dibi
country: Cameroon
facility: CMA Dibi
state: Adamawa
city: Mbe
country: Cameroon
facility: CMA Mbe
state: Adamawe
city: Biyem Assi
country: Cameroon
facility: HD Biyem-Assi
state: Center
city: Cite Verte
country: Cameroon
facility: HD Cite Verte
state: Center
city: Djoungolo
country: Cameroon
facility: CMMR Etoudi
state: Center
city: Efoulan
country: Cameroon
facility: CMA Ahala
state: Center
city: Mbalmayo
country: Cameroon
facility: CSIU Mbalmayo II
state: Center
city: Mfou
country: Cameroon
facility: CSC Nkoabang
state: Center
city: Nkolndongo
country: Cameroon
facility: Hospital Nicolas Barre
state: Center
city: Obala
country: Cameroon
facility: HD Obala
state: Center
city: Baham
country: Cameroon
facility: CSC Baham
state: West
city: Foumbot
country: Cameroon
facility: HD Foumbot
state: West
city: Mifi
country: Cameroon
facility: HD Mifi
state: West
Study officials:
affiliation: Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé
name: Ankouane Andoulo Firmin
role: PRINCIPAL_INVESTIGATOR
References: