NCT04893616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

March 17, 2021

Last Update Submit

July 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Timeliness of birth dose vaccine administration

    Median hours between birth and administration of oral polio and/or the BCG vaccine

    20 weeks

Secondary Outcomes (1)

  • Coverage of birth dose vaccines

    20 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Other: Integration of vaccination services into delivery services

Interventions

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 Arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Facilities without both units

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CMA Dibi

Dibi, Adamaoua Region, Cameroon

Location

CMA Mbe

Mbé, Adamawe, Cameroon

Location

HD Biyem-Assi

Biyem Assi, Center, Cameroon

Location

HD Cite Verte

Cite Verte, Center, Cameroon

Location

CMMR Etoudi

Djoungolo, Center, Cameroon

Location

CMA Ahala

Efoulan, Center, Cameroon

Location

CSIU Mbalmayo II

Mbalmayo, Center, Cameroon

Location

CSC Nkoabang

Mfou, Center, Cameroon

Location

Hospital Nicolas Barre

Nkolndongo, Center, Cameroon

Location

HD Obala

Obala, Center, Cameroon

Location

CSC Baham

Baham, West Region, Cameroon

Location

HD Foumbot

Foumbot, West Region, Cameroon

Location

HD Mifi

Mifi, West Region, Cameroon

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Ankouane Andoulo Firmin

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

May 19, 2021

Study Start

June 10, 2021

Primary Completion

December 11, 2021

Study Completion

December 31, 2021

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

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.

Locations