10+10+30 Infant Vaccines Communication Via Radio in Ethiopia

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

Study Overview

• Status: Completed
• Conditions: Infant ALL
• Intervention / Treatment: Behavioral: 3-month radio intervention on infant vaccination

Detailed Description

The evaluation is conducted in 2 districts located in the Oromia region of Ethiopia. One of the districts will be allocated to receive the 3-month radio intervention while the other district that will not have access to the radio intervention will serve as the control.

Data collection includes survey of mothers at two "key" times: at baseline (when infants are at most 5 weeks old; but before beginning the intervention) and at endline (including examination of infant vaccination records) at most 21 days after the end of the radio intervention. The same mothers and infants to be followed at endline.

• Study Type: Interventional
• Enrollment (Actual): 1320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Jimma, Ethiopia
    • Jimma University
• United States
  • New York
    • Syracuse, New York, United States, 13244
      • Syracuse University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; A district where the radio intervention will be broadcast.	Behavioral: 3-month radio intervention on infant vaccination; Radio intervention comprising 10-minute drama, 10-minute discussion of the drama by trained health extension workers and 30-minute phone-in from listeners
No Intervention: Control; A district where the radio intervention will not be broadcast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeliness of infant vaccines	Infant's vaccination record or mother's recall based on interviewer-administered questionnaire	up to 3 weeks after the intervention ends
Full coverage of infant vaccines	Infant's vaccination record or mother's recall based on a questionnaire	up to 3 weeks after the intervention ends
Perceived barriers to vaccination	Mother completes interviewer-administered questionnaire at specified times	Immediately before intervention starts, and up to 3 weeks after the intervention ends
Perceived susceptibility to vaccine-preventable diseases in children	Mother completes interviewer-administered questionnaire at specified times	Immediately before intervention starts, and up to 3 weeks after the intervention ends
Perceived benefits of infant vaccines	Mother completes interviewer-administered questionnaire at specified times	Immediately before intervention starts, and up to 3 weeks after the intervention ends
Perceived severity of vaccine-preventable diseases in children	Mother completes interviewer-administered questionnaire at specified times	Immediately before intervention starts, and up to 3 weeks after the intervention ends
Cues to action	Mother completes interviewer-administered questionnaire at specified times	Immediately before intervention starts, and up to 3 weeks after the intervention ends

Collaborators and Investigators

• Sponsor: Syracuse University
• Collaborators: Bill and Melinda Gates Foundation; Texas A&M University; Jimma University
• Investigators: Principal Investigator: Bernard Appiah, DrPH, Syracuse University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: OPP1191306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared upon reasonable request after data analysis. Email Dr. Bernard Appiah at beappiah@syr.edu
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: Will be accessible as part of open access publishing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No