Can Doctors Reduce COVID-19 Misinformation and Increase Vaccine Uptake in Ghana? A Cluster-randomised Controlled Trial

August 12, 2024 updated by: London School of Economics and Political Science

Can Routine Consultations be Used to Reduce COVID-19 Misinformation and Increase Vaccine Uptake? An Experimental Study in Ghana

Whilst Ghana was one of the first countries to start vaccinating its population against COVID-19, less than 30% of the population was fully vaccinated at the end of 2022. To improve COVID-19 vaccine uptake, the government has so far relied on two strategies: sensitization in communities and specific national vaccination days. Against the backdrop of strict budget constraints and the return to normalcy in health-seeking behaviours, the investigators aim to test the effectiveness of leveraging interactions of patients with the healthcare system to reduce misinformation and increase vaccination. The investigators collaborate with the Ghana Health Service to offer vaccination as a default option during routine consultations. To dispel information and encourage vaccination uptake effectively, the investigators test two interventions designed to encourage and equip front-line providers with skills to discuss COVID-19 vaccination with patients. The study evaluates the effect of the two interventions in a cluster-randomised trial where the investigators allocate 120 facilities to one of three groups: a control group where providers are not asked to offer COVID-19 vaccines; a light engagement group, where providers receive information about COVID-19 and vaccines and a light-touch vaccine monitoring device is deployed in their facility, and a communication skills building group, where providers receive all the elements of the light intervention, plus training in motivational engagement techniques to encourage vaccination. The primary outcome will be vaccination uptake and intentions. The study will also evaluate the impact of the intervention on patients' knowledge, beliefs and satisfaction. The investigators will track the effectiveness of the training on providers as well as the extent to which they apply their training to actual practice. Results will contribute to a nascent evidence base on potential ways to encourage adult vaccination during routine consultations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
    • Greater Accra
      • Accra, Greater Accra, Ghana
        • Ghana Health Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Mentally sound adults who are aged 16 years and above
  • Presenting at the health centre on the day of surveys

Exclusion Criteria:

  • Received a COVID-19 vaccination dose within last 6 months, or received 2 or more doses
  • Have fever, chills, or are experiencing severe pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Standard of care - no engagement or communication skills training for first-line providers.
Active Comparator: Doctors Light Communication

In facilities randomised to this group, all front-line health workers receiving patients in outpatient consultations over the trial duration will be asked to encourage eligible patients to get vaccinated or receive a booster of the Covid-19 vaccine.

At the start of the intervention period, all facilities will receive a visit from the District office of the Ghana Health Service. The visit will (1) remind them of the importance of covid19 vaccination to all consulting staff; (2) ask all consulting staff to have discussions with patients about Covid19 vaccination during routine consultations and (3) provide a simple tracking sheet to be used by consulting staff to record these consultations.
Behavioral: Facility engagement
A letter to the facility from the local health officials; a meeting with the facility manager and health staff to formally announce that we would like providers to encourage COVID-19 vaccinations; deploying a tracking sheet for vaccinations.
Experimental: Doctors Enhanced Communication
In addition to facility engagement described in the "Doctor light communication" group, five front-line health workers from each of the facilities in the treatment group will be invited to take part in a training providing information and developing specific communication skills to encourage patients to get vaccinated. The communication skills are based on principles rooted in Motivational Interviewing (MI) and have been used in Ghana to address vaccine hesitancy.
Behavioral: Facility engagement
A letter to the facility from the local health officials; a meeting with the facility manager and health staff to formally announce that we would like providers to encourage COVID-19 vaccinations; deploying a tracking sheet for vaccinations.
Behavioral: Motivational Interviewing, AIMS
Motivational interviewing (MI). MI is an approach to patient engagement which promotes a collaborative conversation style for strengthening a person's own motivation and commitment to change. With MI, the doctor facilitates patient exploration of potential reasons for behaviour change in the context of what is important to the patient, rather than the physician directly telling the patient what to do. MI has been found more effective than other approaches to patient engagement and health behaviour change and can be effectively taught to primary care providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
COVID-19 vaccination uptake rates in the health centre
Time Frame: 8 weeks
8 weeks
Proportion of patients who intend to get vaccinated
Time Frame: Immediately after treatment
Immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Economics and Political Science

Collaborators

Innovations for Poverty Action
Ghana Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share a complete dataset at the individual-level containing all primary and secondary study outcomes, any other variables used in the analysis, and treatment assignments. Data will be anonymised to ensure no participants can be personally identified (directly or indirectly)

IPD Sharing Time Frame

Data will be available permanently. They will become available along with the publication of the study in a journal, as we will provide a replication package as part of the publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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