NCT06191211

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 7, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

December 29, 2023

Last Update Submit

August 12, 2024

Conditions

Keywords

Vaccination HesitancyCommunication

Outcome Measures

Primary Outcomes (2)

  • COVID-19 vaccination uptake rates in the health centre

    8 weeks

  • Proportion of patients who intend to get vaccinated

    Immediately after treatment

Study Arms (3)

Control group

NO INTERVENTION

Standard of care - no engagement or communication skills training for first-line providers.

Doctors Light Communication

ACTIVE COMPARATOR

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

Doctors Enhanced Communication

EXPERIMENTAL

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: Motivational Interviewing, AIMSBehavioral: Facility engagement

Interventions

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.

Doctors Enhanced Communication

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.

Doctors Enhanced CommunicationDoctors Light Communication

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghana Health Service

Accra, Greater Accra Region, Ghana

Location

MeSH Terms

Conditions

COVID-19Vaccination HesitancyCommunication

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2023

First Posted

January 5, 2024

Study Start

February 7, 2024

Primary Completion

May 15, 2024

Study Completion

May 15, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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)

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
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.

Locations