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

NCT05107479 | Completed

• 1 other identifier: 61246
• Study Type: interventional
• Target: 8,959
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19 Vaccine Knowledge; COVID-19 Vaccine Beliefs

Outcome Measures

Primary Outcomes (3)

• 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

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

• COVID-19 vaccination status

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

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

• COVID-19 vaccine promotion

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

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

Secondary Outcomes (3)

• COVID-19 vaccine administration preparedness

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

• Belief about COVID-19 vaccination safety

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

• Belief about COVID-19 vaccination efficacy

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

Study Arms (2)

Treatment

EXPERIMENTAL

The 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.

Behavioral: COVID-19 Vaccine IVR Training

Control

ACTIVE COMPARATOR

Participants in the control group will receive the intervention following a one-month delay allowing for a comparison of outcomes with the treatment group.

Behavioral: Control Condition

Interventions

COVID-19 Vaccine IVR Training BEHAVIORAL

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.

Treatment

Control Condition BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Viamo: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 25902967 BACKGROUND

• 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.

  PMID: 24953141 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Since data will be entered directly by health workers via IVR, the outcomes assessor (ie: IVR platform) will have no knowledge of the interventions assigned to individual participants. Additionally, the control group health workers will not be informed they are part of a control arm, but rather that they will receive the training after a delay.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Evaluation Director, Stanford Center for Health Education

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 4, 2021
• Study Start: November 9, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

US (1)