NCT04913714

Brief Summary

A cohort study to investigate the effectiveness of radio intervention comprising 10-minute of drama, 10-minute of discussion led by community extension workers, and 30-minute phone-in from listeners on childhood vaccination coverage and timeliness

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 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

Study Start

First participant enrolled

October 13, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

May 26, 2021

Last Update Submit

June 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Penta 3 vaccine coverage of infant

    Infant's vaccination record or mother's recall based on interviewer-administered questionnaire

    up to 3 weeks after the intervention ends

Secondary Outcomes (7)

  • Timeliness of infant vaccines

    up to 3 weeks after the intervention ends

  • Full coverage of infant vaccines

    up to 3 weeks after the intervention ends

  • Perceived barriers to vaccination

    Immediately before intervention starts, and up to 3 weeks after the intervention ends

  • Perceived susceptibility to vaccine-preventable diseases in children

    Immediately before intervention starts, and up to 3 weeks after the intervention ends

  • Perceived benefits of infant vaccines

    Immediately before intervention starts, and up to 3 weeks after the intervention ends

  • +2 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

A district where the radio intervention will be broadcast.

Behavioral: 3-month radio intervention on infant vaccination

Control

NO INTERVENTION

A district where the radio intervention will not be broadcast.

Interventions

Radio intervention comprising 10-minute drama, 10-minute discussion of the drama by trained health extension workers and 30-minute phone-in from listeners

Intervention

Eligibility Criteria

Age1 Day - 5 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Mother, with infant of at most 5 weeks old; Lives in the study district; Consents to participate in study

You may not qualify if:

  • Mother, with infant of more than 5 weeks old; Does not live in study district; Does not consent to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Syracuse University

Syracuse, New York, 13244, United States

Location

Jimma University

Jimma, Ethiopia

Location

Study Officials

  • Bernard Appiah, DrPH

    Syracuse University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analyst did not know which group received the intervention
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 4, 2021

Study Start

October 13, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

De-identified data will be shared upon reasonable request after data analysis. Email Dr. Bernard Appiah at beappiah@syr.edu

Time Frame
After publication
Access Criteria
Will be accessible as part of open access publishing

Locations