Hepatitis BNCT04893616
Cameroon HepB Birth Dose Feasibility Pilot
A study testing Integration of vaccination services into delivery services in people with Hepatitis B, run by Clinton Health Access Initiative Inc. at 13 sites in Cameroon.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Integration of vaccination services into delivery services
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 13 sitesCameroon
- Study dates
- 10 Jun 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Facilities will be those that have both an immunization unit as well as a maternity ward
Who cannot join
- Facilities without both units
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Cameroon13 sites
CSC Baham
Baham, West Region
HD Biyem-Assi
Biyem Assi, Center
HD Cite Verte
Cite Verte, Center
CMA Dibi
Dibi, Adamaoua Region
CMMR Etoudi
Djoungolo, Center
CMA Ahala
Efoulan, Center
HD Foumbot
Foumbot, West Region
CSIU Mbalmayo II
Mbalmayo, Center
CMA Mbe
Mbé, Adamawe
CSC Nkoabang
Mfou, Center
HD Mifi
Mifi, West Region
Hospital Nicolas Barre
Nkolndongo, Center
HD Obala
Obala, Center
About this study
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
This feasibility assessment is to provide quantitative findings of an intervention integrating immunizations into maternity and newborn care across 15 health facilities in Cameroon.
Read the 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.
- Conditions
- Hepatitis B
- Being tested
- Integration of vaccination services into delivery services
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integration of vaccination services into delivery servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | These facilities will be those selected to have the intervention carried out. Receives: Other: Integration of vaccination services into delivery services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeliness of birth dose vaccine administration
Median hours between birth and administration of oral polio and/or the BCG vaccine
Measured: 20 weeks
Secondary outcomes (1)
Coverage of birth dose vaccines
The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start10 Jun 2021
- Primary completion11 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinton Health Access Initiative Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Cameroon Expanded Program on Immunization, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Ankouane Andoulo Firmin, Principal investigator, Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893616
- Sponsor's protocol ID
- 2020/09/1695/L/CNERSH/SP
- Status last verified
- Jul 2022
- First submitted
- 17 Mar 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04893616
- Acronym / sponsor ID
- 2020/09/1695/L/CNERSH/SP
- Conditions
- Hepatitis B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Clinton Health Access Initiative Inc.University, hospital or other
- Collaborators
- Cameroon Expanded Program on Immunization, Bill and Melinda Gates Foundation
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 11 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Integration of vaccination services into delivery servicesThese facilities will be those selected to have the intervention carried out. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Facilities will be those that have both an immunization unit as well as a maternity ward
Key exclusion criteria (1 listed)
- Facilities without both units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integration of vaccination services into delivery servicesThe 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. | Other | Intervention Arm |
Primary outcome
Timeliness of birth dose vaccine administration
Time frame: 20 weeks
Median hours between birth and administration of oral polio and/or the BCG vaccine
1 secondary outcome
Coverage of birth dose vaccines
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ankouane Andoulo Firmin principal investigator
Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integration of vaccination services into delivery services in people with Hepatitis B, run by Clinton Health Access Initiative Inc. at 13 sites in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeliness of birth dose vaccine administration (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.