Infant ALLNCT04913714
10+10+30 Infant Vaccines Communication Via Radio in Ethiopia
A study testing 3-month radio intervention on infant vaccination in people with Infant ALL, run by Syracuse University at 2 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 1 day to 5 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant ALL
- What is being tested?
- 3-month radio intervention on infant vaccination
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Oct 2020to 31 Jan 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 1 day to 5 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother, with infant of at most 5 weeks old; Lives in the study district; Consents to participate in study
Who cannot join
- Mother, with infant of more than 5 weeks old; Does not live in study district; Does not consent to participate in study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
Read the 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.
- Conditions
- Infant ALL
- Being tested
- 3-month radio intervention on infant vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-month radio intervention on infant vaccinationBehavioural
Radio intervention comprising 10-minute drama, 10-minute discussion of the drama by trained health extension workers and 30-minute phone-in from listeners
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | A district where the radio intervention will be broadcast. Receives: Behavioral: 3-month radio intervention on infant vaccination |
| Control | No intervention | A district where the radio intervention will not be broadcast. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penta 3 vaccine coverage of infant
Infant's vaccination record or mother's recall based on interviewer-administered questionnaire
Measured: up to 3 weeks after the intervention ends
Secondary outcomes (7)
Timeliness of infant vaccines
Infant's vaccination record or mother's recall based on interviewer-administered questionnaire
Measured: 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
Measured: up to 3 weeks after the intervention ends
Perceived barriers to vaccination
Mother completes interviewer-administered questionnaire at specified times
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately before intervention starts, and up to 3 weeks after the intervention ends
Cues to action
Mother completes interviewer-administered questionnaire at specified times
Measured: Immediately before intervention starts, and up to 3 weeks after the intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start13 Oct 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant ALLStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- Jimma University, Texas A&M University, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Bernard Appiah, DrPH, Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913714
- Sponsor's protocol ID
- OPP1191306
- Status last verified
- Jun 2021
- First submitted
- 26 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon reasonable request after data analysis. Email Dr. Bernard Appiah at beappiah@syr.edu
Publications
Appiah B, Otieku E, Gebretsadik LA, Asefa Y, Kampamba M, Mamo A, Annor C, Morankar S, Mwangilwa K, Fenny AP. Cost-effectiveness evaluation of a radio campaign to improve full vaccination coverage among children under-five in Ethiopia. BMC Public Health. 2026 Jun 16. doi: 10.1186/s12889-025-25441-x. Online ahead of print.
PubMed 42298502
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10+10+30 Infant Vaccines Communication Via Radio in Ethiopia
- ClinicalTrials.gov ID
- NCT04913714
- Acronym / sponsor ID
- OPP1191306
- Conditions
- Infant ALL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,320 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- Jimma University, Texas A&M University, Bill and Melinda Gates Foundation
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 4 Jun 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.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: 3-month radio intervention on infant vaccinationA district where the radio intervention will be broadcast. |
| Control | No intervention | –A district where the radio intervention will not be broadcast. |
Who may qualify
- Ages
- 1 day to 5 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Mother, with infant of at most 5 weeks old; Lives in the study district; Consents to participate in study
Key exclusion criteria (1 listed)
- Mother, with infant of more than 5 weeks old; Does not live in study district; Does not consent to participate in study
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 |
|---|---|---|
| 3-month radio intervention on infant vaccinationRadio intervention comprising 10-minute drama, 10-minute discussion of the drama by trained health extension workers and 30-minute phone-in from listeners | Behavioural | Intervention |
Primary outcome
Penta 3 vaccine coverage of infant
Time frame: up to 3 weeks after the intervention ends
Infant's vaccination record or mother's recall based on interviewer-administered questionnaire
7 secondary outcomes
Timeliness of infant vaccines
Time frame: up to 3 weeks after the intervention ends
Full coverage of infant vaccines
Time frame: up to 3 weeks after the intervention ends
Perceived barriers to vaccination
Time frame: Immediately before intervention starts, and up to 3 weeks after the intervention ends
Perceived susceptibility to vaccine-preventable diseases in children
Time frame: Immediately before intervention starts, and up to 3 weeks after the intervention ends
Perceived benefits of infant vaccines
Time frame: Immediately before intervention starts, and up to 3 weeks after the intervention ends
Perceived severity of vaccine-preventable diseases in children
Time frame: Immediately before intervention starts, and up to 3 weeks after the intervention ends
Cues to action
Time frame: Immediately before intervention starts, and up to 3 weeks after the intervention ends
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 4 Jun 2021.
- Derived from this study: PubMed 42298502Appiah B, Otieku E, Gebretsadik LA, Asefa Y, Kampamba M, Mamo A, Annor C, Morankar S, Mwangilwa K, Fenny AP. Cost-effectiveness evaluation of a radio campaign to improve full vaccination coverage among children under-five in Ethiopia. BMC Public Health. 2026 Jun 16. doi: 10.1186/s12889-025-25441-x. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon reasonable request after data analysis. Email Dr. Bernard Appiah at beappiah@syr.edu
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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.
Bernard Appiah, DrPH principal investigator
Syracuse University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-month radio intervention on infant vaccination in people with Infant ALL, run by Syracuse University at 2 sites in 2 countries.
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 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Ethiopia. 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?
Penta 3 vaccine coverage of infant (time frame: up to 3 weeks after the intervention ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913714, which also lists 1 linked publication.
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 4 Jun 2021.