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COVID-19 Vaccine KnowledgeNCT05107479

Effectiveness of Interactive Voice Response for COVID-19 Vaccination Training in the Democratic Republic of the Congo

A study testing COVID-19 Vaccine IVR Training in people with COVID-19 Vaccine Knowledge and COVID-19 Vaccine Beliefs, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study seeks to evaluate the effectiveness of a remote training course delivered via interactive voice response (IVR) to the mobile phones of frontline providers in the Democratic Republic of the Congo (DRC) during the COVID-19 pandemic. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
COVID-19 Vaccine IVR Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,959 participants
Where
1 siteUnited States
Study dates
9 Nov 2021to 10 Feb 2022
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Identified by the DRC Ministry of Health as priority health worker to receive the training

Who cannot join

  • Not identified by the DRC Ministry of Health as priority health worker to receive the training

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Effectiveness of Interactive Voice Response (IVR) for COVID-19 Vaccination Training of Frontline Health Workers: Experimental Evidence From the Democratic Republic of the Congo

This study seeks to evaluate the effectiveness of a remote training course delivered via interactive voice response (IVR) to the mobile phones of frontline providers in the Democratic Republic of the Congo (DRC) during the COVID-19 pandemic. The randomized trial will examine the impact of the training on health workers' knowledge, beliefs and intended behaviors related to COVID-19 vaccines and vaccine administration. Potential enrollees will be consented first, after which the participants assigned to the treatment group will be invited to participate in the training over a one month period, while the control group will receive the intervention following a month delay, which will allow for the comparison of knowledge and beliefs with a group that is controlled for bias introduced by time. We hypothesize that the training will lead to increased knowledge about vaccines, lower vaccine hesitancy, and increased preparedness to administer vaccines among trained health workers.

Read the detailed description

Background:

As COVID-19 continues to pose a significant threat worldwide, training health workers to administer the COVID-19 vaccine and encourage uptake of the vaccine is essential to limiting the number of deaths and ultimately ending the pandemic. Providing adequate training to health workers in low- and middle-income countries (LMICs) had already been logistically and economically challenging, but the onset of the pandemic has intensified the challenge of providing critical and rapidly evolving health information to health workers at a time when it is needed most, particularly in low bandwidth areas where access to accurate sources of information are limited.

A growing body of research suggests that effective and efficient training can be provided through mobile health (mHealth) solutions. The rapid expansion of mobile phone technology available throughout LMICs has enabled the scaling of health education delivery via mobile phone. However, while app-based learning has grown in popularity, drawbacks include limited access to smartphones and the data costs to access the internet, if available. Interactive voice response (IVR) systems pose an alternative solution by employing pre-recorded audio files in local languages, allowing users to receive information from mobile phones without the need for internet access.

Aims:

In this study, we investigate the effectiveness of an IVR training intervention for improving knowledge of COVID-19 vaccines and vaccine administration among health workers in the Democratic Republic of the Congo (DRC). We will also examine differences in effectiveness across subgroups including by geographic region, professional roles (e.g., nurses, physicians) and type of health worker facility.

Methods:

We are collaborating with Viamo, a global social enterprise that has established IVR systems in more than 23 countries, to conduct a randomized controlled trial to measure the effects of the IVR remote training on health workers' knowledge and beliefs about COVID-19 vaccines and preparedness to administer vaccines. In coordination with the DRC Ministry of Health, Viamo has identified roughly 9,000 facility-based health workers prioritized for participation. Participants will be randomized 1:1 into a treatment and a control group, stratified by geographic region and professional roles to ensure equal representation across regions and types of health workers.

The participants in the treatment group will receive the intervention at the start of the study while the participants in the control group will receive the intervention following a one-month delay, which will allow for the comparison of knowledge, attitudes and practices with a group that is controlled for bias introduced by time. The duration of the study for participants will be roughly one month, which is the time it takes to complete the 5 required IVR training modules and a baseline and endline survey.

Intervention:

Training content is being developed by Viamo in collaboration with the Stanford Center for Health Education and the DRC Ministry of Public Health. The intervention consists of 5 IVR-based modules conveying information about COVID-19 vaccines and vaccine administration best practices. Module topics include the following: 1) the importance of COVID-19 vaccines and recipient eligibility, 2) overview of and differences between approved COVID-19 vaccines , 3) surveillance of adverse vaccine events, 4) organizing a vaccination site, and safe storage and handling COVID-19 vaccines, and 5) micro planning and communication strategies for COVID-19 vaccination efforts. The training will be offered in five local languages: French, Lingala, Swahili, Kikongo, and Tshiluba.

Sample size calculation:

The DRC Ministry of Health identified roughly 9,000 health workers located in 13 focal provinces for prioritization of the training. With a total sample size of 9,000 (including both arms), we estimate a minimum detectable effect size (MDES) of 5.6 percentage points (at 80 percent power and a 5 percent significance level). Because of the voluntary nature of the IVR training participation, we anticipate a response rate of lower than 50 percent. At 80 percent power and 5 percent significance, a sample size of 2900 participants (over both arms) is needed to detect a 10 percent difference.

Data collection and training:

Data will be collected via the IVR platform. Treatment and control groups will complete a baseline and endline survey administered at the same time. The baseline survey will include a brief knowledge assessment, questions about participants' vaccination status, beliefs about COVID-19 vaccines, and preparedness to administer vaccines. The baseline also includes demographic and background questions about participants' prior work experience. The endline survey includes a more extensive knowledge assessment and questions about participants' vaccination status, beliefs about COVID-19 vaccines, and preparedness to administer vaccines.

All surveys will be completed directly by participants via IVR calls direct to participants' mobile phones. Surveys and training content will include audio prompts to overcome literacy barriers and will be offered in one of five local languages, selected by participants directly.

Participants will be trained on how to use the IVR technology on their mobile devices at the start of the study. Callers interact with pre-recorded audio files in their local languages and can choose what information they want to receive using their mobile phone keypads ("For more information on prevention, please press 1").

While the intervention group will be invited to begin the IVR training immediately after completing the baseline survey, the control arm will have a roughly one month delay before receiving the intervention. Besides the short delay, every aspect for treatment and control arms will remain the same.

Data Analysis:

The primary analysis will be based on intention-to-treat at the unit of the individual CHW. The analysis will include randomization strata fixed effects and control for baseline covariates to improve precision of estimates. Because we will have granular by-module completion data across participants, we will also conduct a treatment-on-the-treated instrumental variables analysis to examine the impact of the training on outcomes, among participants completing the training.

Being tested
COVID-19 Vaccine IVR Training, Control Condition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID-19 Vaccine IVR TrainingBehavioural

    The intervention consists of 5 interactive voice response (IVR) modules conveying information about COVID-19 vaccines and vaccine administration best practices. Module topics include the following: 1) the importance of COVID-19 vaccines and recipient eligibility, 2) overview of and differences between approved COVID-19 vaccines , 3) surveillance of adverse vaccine events, 4) organizing a vaccination site, and safe storage and handling COVID-19 vaccines, and 5) micro planning and communication strategies for COVID-19 vaccination efforts. The training will be offered in five local languages: French, Lingala, Swahili, Kikongo, and Tshiluba.

  • Control ConditionBehavioural

    The control arm will receive the COVID-19 Vaccine IVR Training after an estimated month-long delay. The control arm will be told upon completion of the baseline survey that the training will commence at a later estimated date and will not receive any additional information until the treatment group completes training.

Study groups in NCT05107479
Study groupRoleWhat they receive
TreatmentExperimentalThe participants in the treatment group will be invited to participate in a 5-module IVR training covering an overview of available COVID-19 vaccines and best practices for vaccine administration.
Receives: Behavioral: COVID-19 Vaccine IVR Training
ControlActive comparatorParticipants in the control group will receive the intervention following a one-month delay allowing for a comparison of outcomes with the treatment group.
Receives: Behavioral: Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COVID-19 vaccine knowledge

    Standardized score on an assessment of 10 knowledge questions about COVID-19 vaccines and vaccine administration, drawn directly from the IVR curriculum

    Measured: Collected after the estimated 1 month time period to complete the IVR training

  2. COVID-19 vaccination status

    Current vaccination status (i.e., having received at least one dose of a COVID-19 vaccine)

    Measured: Collected after the estimated 1 month time period to complete the IVR training

  3. COVID-19 vaccine promotion

    Whether participant has ever encouraged someone to receive a COVID-19 vaccine

    Measured: Collected after the estimated 1 month time period to complete the IVR training

Secondary outcomes (3)
  1. COVID-19 vaccine administration preparedness

    Agreement (on 3 point likert scale) with statement that participant feels confident and prepared to administer COVID-19 vaccines. Scale options: 1-disagree (minimum), 2-unsure, 3-agree (maximum), with maximum representing the better outcome.

    Measured: Collected after the estimated 1 month time period to complete the IVR training

  2. Belief about COVID-19 vaccination safety

    Agreement (on 3 point likert scale) with statement that COVID-19 vaccines are safe. Scale options: 1-disagree (minimum), 2-unsure, 3-agree (maximum), with maximum representing the better outcome.

    Measured: Collected after the estimated 1 month time period to complete the IVR training

  3. Belief about COVID-19 vaccination efficacy

    Agreement (on 3 point likert scale) with statement that COVID-19 vaccines are effective. Scale options: 1-disagree (minimum), 2-unsure, 3-agree (maximum), with maximum representing the better outcome.

    Measured: Collected after the estimated 1 month time period to complete the IVR training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2021
  2. Study start9 Nov 2021
  3. Primary completion10 Feb 2022
  4. Study completion10 Feb 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized trial with baseline covariate adjustment and stratification. The randomization unit is the health worker. The randomization will be stratified by province, health worker role, and whether the health worker holds a supervisory role to ensure balance of intervention versus control across characteristics. The following baseline characteristics will be measured and adjusted for in the main analysis of primary outcomes to increase statistical efficiency: 1) age, 2) gender, 3) years of work experience in healthcare, 4) prior vaccination experience, 5) facility type, 6) COVID-19 vaccination status, 7) COVID-19 vaccine knowledge, and 8) COVID-19 vaccine beliefs.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
8,959 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05107479
Sponsor's protocol ID
61246
Status last verified
Feb 2022
First submitted
11 Oct 2021
Last updated
21 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Arie S. Can mobile phones transform healthcare in low and middle income countries? BMJ. 2015 Apr 22;350:h1975. doi: 10.1136/bmj.h1975. No abstract available.

    PubMed 25902967
  • Agarwal S, Labrique A. Newborn health on the line: the potential mHealth applications. JAMA. 2014 Jul 16;312(3):229-30. doi: 10.1001/jama.2014.6371. No abstract available.

    PubMed 24953141

Questions about this trial

What is this clinical trial studying?

A study testing COVID-19 Vaccine IVR Training in people with COVID-19 Vaccine Knowledge and COVID-19 Vaccine Beliefs, run by Stanford University at 1 site in United States.

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 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

COVID-19 vaccine knowledge (time frame: Collected after the estimated 1 month time period to complete the IVR training). The study lists 3 primary outcomes in all. 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 NCT05107479, which also lists 2 linked publications.

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 21 Feb 2022.

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