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

Infant ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04913714
• Other study ID #: OPP1191306
• Status: Completed
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: June 2021
• Source: Syracuse University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1320
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infant ALL

Intervention

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

Locations

Country	Name	City	State
Ethiopia	Jimma University	Jimma
United States	Syracuse University	Syracuse	New York

Sponsors (4)

Lead Sponsor	Collaborator
Syracuse University	Bill and Melinda Gates Foundation, Jimma University, Texas A&M University

Countries where clinical trial is conducted

United States,  Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cues to action	Mother completes interviewer-administered questionnaire at specified times	Immediately before intervention starts, and up to 3 weeks after the intervention ends